Yourlawyer.com (Fosamax News) http://www.yourlawyer.com/topics/overview/fosamax Fri, 20 Nov 2009 23:25:57 -0800 pixel-app en Judge Rules not to Dismiss 24 Fosamax Lawsuits http://www.yourlawyer.com/articles/read/16964 Thu, 10 Sep 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16964 Fosamax lawsuits filed by people who took the drug for less than  three years will not be dismissed.   In a ruling released yesterday, U.S. District Judge John Keenan also said that testimony from two plaintiffs' experts is admissible at trial.

Fosamax is one of a number of drugs used to treat osteoporosis known as bisphosphonates. Bisphosphonates have been linked to a side effect known as Osteonecrosis of the Jaw (ONJ). Also known as Dead Jaw Syndrome, ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.

In 2005, the Food & Drug Administration (FDA) ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ. Since then, more than 1,200 plaintiff groups have filed 900 Fosamax lawsuits in courts around the country.

Merck & Co. had sought the dismissal of Fosamax lawsuits involving plaintiffs who had taken the drug for less than three years.  But in his ruling, Judge Keenan wrote that whether there is a three- year threshold is a “genuine issue of fact for trial," Bloomberg.com said.

According to Reuters, Judge Keenan ruled that he would allow plaintiffs to introduce testimony by two doctors to show that the drug can cause jaw damage after less than three years of continuous use.  The judge said that the evidence is sufficiently reliable to allow a rational jury to establish such a connection.

However, the judge also ruled that testimony of a third plaintiffs' expert would not be allowed because the witness had previously said Fosamax doesn’t cause ONJ in patients who take the drug for less than a three year  period.  According to Bloomberg.com, that witness - Dr. Robert Marx - began changing his stance on the three-year limit in 2008.

Meanwhile, Dow Jones is reporting that  Judge Keenan has also called for a one-day cooling-off period in the first Fosamax lawsuit to go to trial after jury deliberations became tense. On Tuesday, Judge Keenan had asked jurors to continue deliberations after they indicated that they were at an impasse.  But on Wednesday, an attorney for the plaintiff asked for a mistrial, saying one juror had indicated in a note that she was being intimidated and had been threatened, Dow Jones said.  The juror's note claimed she had been the subject of threats of physical violence and had a chair thrown at her.

]]> First Fosamax Trial Starts Today http://www.yourlawyer.com/articles/read/16866 Tue, 11 Aug 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16866 Fosamax jaw damage lawsuits is scheduled to go to trial today in a Manhattan federal courtroom. According to Bloomberg.com, the Fosamax lawsuit is the first of  three so-called bellwether cases, the outcomes of which may determine if there will be out-of-court settlements in other cases.

Fosamax is one of a number of drugs used to treat osteoporosis known as bisphosphonates.  Other drugs in this class include Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa.  

Bisphosphonates have been linked to a side effect known as Osteonecrosis of the Jaw (ONJ).  Also known as Dead Jaw Syndrome, ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include:  jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.

In 2005, the Food & Drug Administration (FDA) ordered that the  label for Fosamax and other bisphosphonates be updated to include warnings about ONJ.  Since then, more than 1,200 plaintiff groups have filed 900 Fosamax lawsuits in courts around the country.

Plaintiffs in the lawsuits claim Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, Bloomberg.com said.  They also claim that when Merck updated the label in 2005, the company still failed to adequately warn about the drug's risks.  An attorney for some plaintiffs told Bloomberg.com that Merck was the only drug company not to use the language for the warning that the FDA requested

The first Fosamax lawsuit slated for trial involves a 71-year-old Florida woman who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006, Reuters said.  According to the Reuters report, two other Fosamax lawsuits are scheduled  to go to trial later this year, one in federal court and another in a state court in Alabama.  

]]> Fosamax, Other Osteoporosis Drugs Linked to Cancer http://www.yourlawyer.com/articles/read/15777 Fri, 02 Jan 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15777 Fosamax (generically known as alendronate)  may be among the bone drugs that carry such a risk.  About 10 million Americans—the vast majority of whom are female—suffer from osteoporosis, said Reuters.

Reuters reports that Diane Wysowski of the FDA's drug risk assessment division advised researchers to review links between bisphosphonates and an increased cancer risk.  Health Day News explained that bisphosphonates are used to reduce the risk of bone fracture, while increasing bone mass in patients suffering from osteoporosis and are used to decelerate bone "turnover" in cancer patients whose disease reached the bones as well as those suffering from multiple myeloma, a type of blood cancer.  Bisphosphonates such as Fosamax have also been linked to an increased risk of atrial fibrillation, thigh bone fractures, and inflammatory eye disease, said HealthDayNews.

Wysowski discussed a letter in yesterday’s New England Journal of Medicine in which 23 patients developing esophageal tumors have been reported since Fosamax was first marketed in 1995, says Reuters; eight patients died.  Wysowski added, said Reuters, there seems to be a two-year period between initiating Fosamax and developing the cancer.  Also, said Reuters, in Europe and Japan, 21 cases involving Fosamax have been reported with six cases linked to Procter & Gamble's Actonel (risedronate) and Didronel (etidronate), and Roche's Boniva (ibandronate); six patients have died.

Fosamax and other bisphosphonates treatment involves patients remaining upright for at least one-half hour following dosing because of the well-established side effect of esophagitis, inflammation of the esophagus, reports Reuters.  Wysowski also warned physicians should not prescribe bisphosphonates to patients with Barrett's esophagus, a condition in which an esophageal change common in acid reflux patients occurs and that is also known to increase cancer risks, added Reuters.

Meanwhile, HealthDayNews reports that oral osteoporosis drugs are linked, in much greater incidence than was first believed to osteonecrosis of the jaw (ONJ); the risk is increased with the higher-dose intravenous (IV) form of bisphosphonates.  Dr. Parish Sedghizadeh, an assistant professor of clinical dentistry at the University of Southern California School of Dentistry in Los Angeles, told HealthDayNews that his clinic has seen a seriously marked increase in such cases:  In the past the clinic would see one case annually and is now seeing one to four cases weekly.  

The findings prompted his investigation and are published in yesterday’s Journal of the American Dental Association, said HealthDayNews.  According to HealthDayNews, OSJ is known to cause pain, soft-tissue swelling, infection, loose teeth, and exposed bone and can occur in patients taking Fosamax as short as one year and tends to occur following invasive dental work.

Last year, the FDA posted an alert on its Website stating that patients being treated with bisphosphonates might develop “disabling pain” in the muscles, joints, and bones—a known risk detailed in the warning label; in some cases, the pain is reported to be "incapacitating" for normal movement like walking.

]]> Zometa, Reclast, Boniva Infusions Linked to Eye Inflammation http://www.yourlawyer.com/articles/read/15219 Fri, 26 Sep 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/15219 Zometa, Reclast and Boniva infusions have been linked to a rare inflammatory eye disease, according to a letter published in the "New England Journal of Medicine" (NEJM).  The Australian doctors who authored the letter wrote that infusions of these drugs should be "used with caution, or avoided altogether, in patients with acute ocular inflammation or a history of inflammatory eye disease or uveitis."   

Zometa, Reclast and Boniva are part of a class of drugs known as bisphosphonates, which also includes Fosamax, Didronel, Boniva, Aredia, Actonel, and Skelid.  They were first approved by the Food & Drug Administration (FDA) to reduce the risk of bone fracture and to increase bone mass in people with osteoporosis.  Bisphosphonates are also administered via infusion to slow bone turnover in people who have cancer that has spread to their bones, and to lower excessive levels of calcium in the blood in some people with cancer.  Bisphosphonates are also used to treat Paget's disease of bone.

According to the letter in the NEJM, a 57-year-old man who received an infusion of zoledronic acid (Zometa or Reclast) and three people who received infusions of Boniva developed inflammatory eye disease.  All four reported cases were treated with corticosteroids and improved in days.

Inflammatory eye disease is only the latest of a variety of side effects linked to bisphosphonates. Earlier this year Canadian researchers published a study that linked the drugs to bone necrosis, a painful condition where bone tissue dies.  Several studies have also linked  prolonged Fosamax use to an increased the risk of  low-energy femur fractures.

The FDA also issued an advisory this year  that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain.  The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. LastOctober, the FDA announced it would be conducting a safety review of Fosamax and other  bisphosphonates after a study published the previous May in the NEJM found that patients taking these drugs had high rates of atrial fibrillation.

The FDA has also had the makers of Fosamax and other bisphosphonates  include a warning about their association with Osteonecrosis of the Jaw (ONJ) on their labeling.  ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue.

]]> Another Study Links Fosamax to Fractures http://www.yourlawyer.com/articles/read/14752 Mon, 14 Jul 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14752 Fosamax—generically known as bisphosphonate alendronate—use may increase the risk of femur fractures, the large thigh bone that connects the leg to the hip.  Continued evidence indicates that long-term alendronate use may overly suppress bone metabolism, which limits the repair of microdamage and increases fracture risk, Dr. Joseph M. Lane and colleagues report in the Journal of Orthopaedic Trauma.
 
To investigate this risk, the team reviewed all 70 patients with femoral fractures who were admitted to their Level 1 trauma center 2002-2007.  The average patient was 75 years of age, the majority of the patients were women, and 25 patients—36 percent—were treated with alendronate.  Also, 19 of 20 patients suffering from the same fracture pattern were taking alendronate.  The other patient was later diagnosed with cancer.  The study also reported that the average duration of alendronate use was significantly longer in those with femoral stress fractures than in the six treated patients without this type of fracture, 6.9 years versus 2.5 years, respectively.  Otherwise, there were no significant differences in age, race, weight, or osteoporosis history among = those without and without this fracture patter.

Lane and his associates have called for more research to determine if this effect is associated with all bisphosphonate drugs and if it became apparent first with alendronate because this drug has been available for the longest time and is the most widely used.  Lane advises that, "physicians prescribing bisphosphonates for longer durations should monitor patients for indications of bone regeneration." Lane recommends that bisphosphonates be discontinued until levels return to normal if a blood test shows a low level of bone turnover.

Meanwhile, earlier this year Canadian researchers issued a warning that bisphosphonates, sold under the names of Didrocal, Actonel, and Fosamax can lead to bone necrosis, a painful and disfiguring condition that results in bone death.  The study found that such drugs almost tripled the risk of developing bone necrosis.  The study was conducted by researchers at the University of British Columbia (UBC) and McGill University and is the largest study of its kind into the connection between bone necrosis and specific brands of bisphosphonates:  Didrocal, Actonel, and Fosamax.  Prior to that warning, the U.S. Food and Drug Administration (FDA) issued a warning about bisphosphonates and its link to a higher possibility of severe and sometimes incapacitating bone, joint, and muscle pain.  "I think the study's important just basically to let the public know if they do experience any severe, unusual pain they could tell their health professional," said Dr. Mahyar Etminan, the principle investigator from the University of British Columbia.

Use of bisphosphonates has increased as the population has aged and Etminan reported that use will likely further increase due to a possible link between estrogen use and breast cancer, prompting women to switch from estrogen therapy to bisphosphonate therapy to stop bone fractures from occurring.  The drugs like Didrocal, Actonel, and Fosamax are also becoming easier to take, with once-a-month and once-a-year doses now available.

]]> Another Fosamax Side Effect: Low Energy Femur Fractures http://www.yourlawyer.com/articles/read/14517 Thu, 05 Jun 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14517 Fosamax, a popular drug for treating osteoporosis, has been linked to a rare type of femur fracture.  Though the study was small, it is just the latest research to link Fosamax to a disturbing side effect.

Fosamax has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues.  One of the most serious is its association with ONJ.  In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition.  ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue.

Earlier this year, the FDA warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain.  The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. In October, the FDA announced it would be conducting a safety review of Fosamax and other osteoporosis drugs in its class, known as bisphosphonates, after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

Now a small, observational study published in the current issue of the "Journal of Orthopedic Trauma" of 70 patients who sustained low-energy femur fractures -which occur when someone falls from a standing height or less - indicates Fosamax might play a role in such injuries. The femur is the long bone of the thigh.

According to the Wall Street Journal, of the patients in the study, twenty-five patients (36%) were taking Fosamax on average for four years or more. The Fosamax patients’ fractures had some distinct characteristics: Nineteen (76%) of the 25 patients had a simple fracture with a straight line across the bone and a beak-like overhang on one side. Also, the patients’ bones didn’t look like typical osteoporotic bone; they  looked strong.

Andrew Neviaser, lead author of the paper and a third-year surgical resident at the Hospital for Special Surgery in N.Y., told The Wall Street Journal that the study indicates that doctors should be aware that some patients who take Fosamax are vulnerable to these types of fractures, and should closely monitor them.

This study is not the first time Fosamax has been linked to such fractures.  In March, the New England Journal of Medicine published a letter written by Joseph M. Lane, MD, chief of the metabolic bone disease service at New York Hospital and colleagues which  reported 15 cases of unusual bone fractures in postmenopausal women who had been taking Fosamax for more than five years.  These women had also suffered from fractures along the length of the femur after falls from standing position or lower. And ten of the patients also had a distinct and unusual fracture pattern. Those ten patients had been taking Fosamax for more than seven years on average; the other five patients averaged less than three years of Fosamax use.

]]> Fosamax Dead Jaw Syndrome Tied to Microbial Biofilms http://www.yourlawyer.com/articles/read/14328 Fri, 02 May 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14328 Fosamax, new research says. These biofilms, a mix of bacteria and sticky extracellular material, are causing jaw tissue infections in patients taking bisphosphonate drugs like Fosamax, Actonel and Boniva, according to a study conducted at the USC School of Dentistry. Earlier this year, another group of researchers linked biofilms to eye infections that were caused by recalled Renu with MoistureLoc Contact Lens solution in 2006.

Osteoporosis drugs are known to carry a number of side effects, including Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the labels for Fosamax and similar drugs was updated to include warnings about ONJ.

The USC researchers said ONJ occurs  when bacteria-laden biofilms infect the jaw after the bone is exposed, typically because of a tooth extraction or injury. The team used powerful scanning electron microscopes to study patients' jawbone samples. The images revealed biofilm bacteria sprawling over pitted tissue. The scientists are now trying to determine why bisphosphonate drugs seem to open the door for biofilm-associated infections of the jaw.

This is not the first time biofilms have been linked to serious side effects.  In 2006, Bausch & Lomb issued a worldwide recall of Renu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness.  Earlier this year, researchers with the Center for Medical Mycology found the strain of Fusarium responsible for the Renu with MoistureLoc outbreak had the ability to form biofilms.  Biofilms are clusters of microbes held together by a glue like matrix.   This structure made the Fusarium extremely resistant to contact lens solutions and the body’s own immune system.

Not all cells can form biofilms, and unfortunately for Renu victims, contact lens solutions are not required to be tested against microbes with this ability.  In fact, Renu with MoistureLoc and other contact lens solutions are tested against a rare type of fungus obtained from a patient in Nigeria in 1970s.

]]> Study Ties Fosamax to Heart Disorder http://www.yourlawyer.com/articles/read/14309 Wed, 30 Apr 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14309 Fosamax, a popular drug used to treat osteoporosis, may be linked to an increased risk of a heart disorder called atrial fibrillation, according to newly published research.  The study raises new concerns about Fosamax, which has also been linked to bone necrosis and other side effects.

Fosamax, manufactured by Merck, was approved by the Food & Drug Administration (FDA) in 1995, and is prescribed to treat osteoporosis and Paget's disease. Fosamax is a type of drug known as a bisphosphonate.  Fosamax is known to carry a number of side effects, including Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.

In January 2008, the FDA  warned that Fosamax had also been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain.  The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur.  The severe musculoskeletal pain associated with Fosamax can occur within days, months, or years after starting treatment with the drug.  While some patients have experienced complete relief of symptoms after discontinuing Fosamax, others have reported that the pain continued.  The risk factors for and incidence of severe musculoskeletal pain associated with Fosamax are unknown.

Now, a study conducted by researchers at the University of Washington has found that treatment with Fosamax could double the risk of atrial fibrillation.  Atrial fibrillation - a chronic, irregular heartbeat - causes fatigue, dizziness and fainting, but it isn't life-threatening.  Women who had taken the drug had an 86% higher risk of atrial fibrillation than those who never took Fosamax, the study found. But these results  were far from conclusive, doctors say. Fosamax accounted for 3% of the atrial fibrillation cases, and 97% were the result of other causes. The researchers said their findings showed a need for more study on this potential Fosamax side effect.

The University of Washington study is not the first to link a bisphosphonate to atrial fibrillation.  The FDA is already looking into the risk, prompted by research published in the May 7 issue of the New England Journal of Medicine  that found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on bisphosphonates found that there appeared to be 50 percent more risk of the heart rhythm irregularity in women who took the drugs than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

]]> Fosamax, Other Osteoporosis Drugs Linked to Bone Weakness http://www.yourlawyer.com/articles/read/14079 Fri, 21 Mar 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14079 Fosamax, the popular osteoporosis drug, may cause bone weakness in some patients that could cause them to suffer bone fractures from minor falls.  According to a letter published in the March 20 issue of the New England Journal of Medicine, the side effect, seen in a small number of Fosamax patients who took the drug for five years, is likely also associated with other similar drugs, known as bisphosphonates.

Bisphosphonates, sold under the brand names Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa,  are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonate drugs are used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously in higher doses and usually for longer periods of time.

A letter written by Joseph M. Lane, MD, chief of the metabolic bone disease service at New York Hospital and professor of special surgery at Weill Medical College of Cornell University and colleagues,  reports on 15 cases of unusual bone fractures in postmenopausal women who had been taking Fosamax for more than five years. All had fractures along the length of the femur, the long bone in the thigh, after falls from standing position or lower. Ten of the patients had a distinct and unusual fracture pattern. These patients had been taking Fosamax for more than seven years on average; the other five patients averaged less than three years of Fosamax use.

According to Dr. Lane, "People on prolonged bisphosphonates — and Fosamax is the only one we have seen so far — after five to seven years are at risk of fractures in the long bone of the leg.  They complained of thigh pain for months before the breaks. So it seems they start off with a stress fracture that is unrecognized, and it goes on to full fracture."

Other medical practitioners have reported similar side effects with long-term use of Fosamax and other bisphosphonates, and many are starting to recommend that such patients take "drug holidays."  This involves bisphosphonate patients who have been taking the drugs for four years going off of them for a year or two.  They return to treatment after it can be determined that bone turnover - the rate at which old bone is replaced by new - is increasing.  This practice is typical in Europe and in Australia, and is becoming more common in a growing number of U.S. bone centers.

Bisphosphonates have been linked to a variety of other safety problem, including Osteonecrosis of the Jaw (ONJ).  Also known as Dead Jaw Syndrome, ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.

Last October, the Food & Drug Administration (FDA) announced that it was reviewing bisphosphonates after studies showed patients taking the drugs ran a higher risk of irregular heartbeat.  Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

Then in January, the FDA warned that bisphosphonates had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain.  he FDA recommended that healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

]]> More Fosamax Side Effects This Time Bone Necrosis http://www.yourlawyer.com/articles/read/13832 Wed, 06 Feb 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13832
"I think the study's important just basically to let the public know if they do experience any severe, unusual pain they could tell their health professional," said Dr. Mahyar Etminan, the principle investigator from the University of British Columbia.

The incidence of bone necrosis is rare, diagnosed in about one in 20,000 people a year, but it is serious and extremely painful and does lead to permanent loss of the blood supply to the bones.  Without blood, the bone tissue dies and causes the bone to collapse.  If necrosis involves the bones near a joint, it often leads to collapse of the joint surface.  What happens is, "The drugs basically hang around in bone for a long period of time and cut off blood supply to the bone, which eventually dies off and becomes necrotic," Etminan explained.

The recent study was collaboration between UBC, The Vancouver Coastal Health Research Institute, and McGill University in Montreal and was based on the health records of 88,000 Quebec residents over a period of seven years.  The team decided to take on the research after academic papers began linking necrosis of the jaw with the use of bisphosphonates.  Etminan said the study allows patients and their doctors to look at the positives and negatives of taking this class of medication.

Meanwhile, use of bisphosphonates medications such as Didrocal, Actonel, and Fosamax has increased as the population has aged.  Etminan said that use will likely further increase due to a possible link between estrogen use and breast cancer, prompting women to switch from estrogen therapy to bisphosphonate therapy to stop bone fractures from occurring.  The drugs like Didrocal, Actonel, and Fosamax are also becoming easier to take, with once-a-month and once-a-year doses now available.

"Our study's take-home message is that you know if you experience severe pain, it may not be because of your osteoarthritis or even osteoporosis and just check it out and make sure it's nothing serious," he said.

The disease primarily affects the shoulders, knees, and hips at the joints.  Etminan said therapy for bone necrosis ranges from non-invasive treatments such as taking anti-inflammatories to invasive surgery involving total joint replacement, depending on the seriousness of the condition.

]]> Another Fosamax Lawsuit http://www.yourlawyer.com/articles/read/13773 Tue, 29 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13773 Fosamax has been named in a lawsuit filed by a Connecticut woman who claims the osteoporosis drug caused multiple stress fractures and suppressed bone regeneration in her legs.  JoAnn Moranski, who took Fosamax for 10 years, is just the latest plaintiff to file suit against Merck as a result of health problems caused by the medication.  Another 400 plaintiffs have Fosamax lawsuits pending that allege the bone medication caused a bone-wasting condition known as osteonecrosis of the jaw (ONJ).

Fosamax, a popular osteoporosis drug, has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues.  One of the most serious is its association with ONJ.  In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition.  ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include:  jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.

Hundreds of patients have sued Merck, claiming that their ONJ was caused by Fosamax.  Earlier this month, a federal judge refused to grant class action status to a group of ONJ lawsuit plaintiffs in Pennsylvania, Florida and Louisiana who wanted Merck to establish a Fosamax medical monitoring fund.  Because of the judge’s decision in this matter, it is expected that the number of Fosamax Dead Jaw Syndrome lawsuits currently making their way through the courts is likely to explode.

But ONJ isn’t the only problem associated with Fosamax.  Just a few weeks ago, the FDA warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain.  The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. In October, the FDA announced it would be conducting a safety review of Fosamax and other osteoporosis drugs in its class, known as bisphosphonates, after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

Despite its safety problems, Fosamax netted Merck sales of nearly $3 billion in 2007.  But the company’s patent protection on Fosamax runs out next month, meaning cheaper generic versions of the drug could soon cut into Merck’s sales.

]]> Fosamax Class Action Ruling Expected to Result in Many More Dead Jaw Syndrome Lawsuits Against Merck http://www.yourlawyer.com/articles/read/13648 Wed, 09 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13648 Fosamax patients concerned that they are at risk for Osteonecrosis of the Jaw (ONJ) will have to file individual lawsuits against Fosamax maker Merck if they want to force the company to pay for medical monitoring for the condition, also known as Dead Jaw Syndrome.   That’s because a federal judge has refused to grant class action status to a group of Fosamax lawsuit plaintiffs in Pennsylvania, Florida and Louisiana who wanted Merck to establish a Fosamax medical monitoring fund.  Because of the judge’s decision in this matter, it is expected that the number of Fosamax Dead Jaw Syndrome lawsuits currently making their way through the courts is likely to explode.

Fosamax, a popular osteoporosis drug, has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues.  One of the most serious is its association with ONJ or Dead Jaw Syndrome.  In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition.  ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include:  jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.

Earlier this week, the FDA warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain.  The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. In October, the FDA announced it would be conducting a safety review of Fosamax and other osteoporosis drugs in its class, known as bisphosphonates, after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

In a ruling dated last Thursday, U.S. District Judge John Keenan denied motions to approve classes of current and former users of the popular drug in Pennsylvania, Florida and Louisiana who have not been diagnosed with Dead Jaw Syndrome. "The court finds that class-treatment of these claims is inappropriate because they present too many individual questions of fact particular to each class member's claim," Keenan wrote in a 41-page ruling.

Had the motion for class action status been approved, current and former Fosamax users could have sued Merck for the costs of medical monitoring as a group, under one complaint.   But now, they will have to seek Fosamax medical monitoring in individual lawsuits.   Because of Judge Keenan’s ruling, it is now estimated that the number of Fosamax cases in federal and state courts would increase to 1,500 to 2,000 by the end of the year from roughly 460 now.  The first federal Fosamax cases are expected to go to trial at the end of the year,

]]> Actonel, Fosamax, other Osteoporosis Drugs Draw FDA Pain Warning http://www.yourlawyer.com/articles/read/13627 Mon, 07 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13627 Fosamax and other anti-osteoporosis drugs known as bisphosphonates have been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain, the Food & Drug Administration (FDA) warned today.  Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the FDA said that the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and impairment, and necessitating the use of analgesics.

Bisphosphonate, sold under the brand names Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa,  are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonate drugs are used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously in higher doses and usually for longer periods of time.

According to today’s FDA warning, the severe musculoskeletal pain associated with bisphosphonates may occur within days, months, or years after starting a bisphosphonate.  Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.  The FDA recommended that healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

Bisphosphonates have been linked to a variety of other safety problems.  In October, the FDA announced that it was reviewing the drugs after studies showed patients taking bisphosphonates ran a higher risk of irregular heartbeat.  Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

Fosamax has also been linked to Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.

]]> Fosamax, Reclast, Other Osteoporosis Drugs to Undergo FDA Safety Review http://www.yourlawyer.com/articles/read/13167 Tue, 02 Oct 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/13167 FDA  safety review of bisphosphonates, a class of drugs often used to increase bone mass in order to treat osteoporosis, was prompted after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

Bisphosphonates are used to increase bone mass and reduce fracture risk in patients with osteoporosis. They also are also used to slow bone turnover in patients with a disorder called Paget's disease and to treat bone metastases and lower blood calcium in cancer patients.  There are currently 8 bisphosphonates approved for use in the US.  They are Fosamax, Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.

Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women.  Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn't take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

A second study published in the same issue of the New England Journal of Medicine cast doubt on another bisphosphonate, Reclast.  In a study of 7,736 postmenopausal women with bone-thinning osteoporosis, the risk of a serious case of irregular heart rhythm was more than double that in the other patients.

In announcing the bisphosphonate safety review, the FDA said that it was “unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time."  The agency will be seeking additional data on the possible atrial fibrillation risks associated with these drugs, and it expects the safety review of bisphosphonates to take about 12 months.

This is not the first time that the safety of Fosamax has been questioned.  The drug has been linked to Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue.  In 2005, the Fosamax label was updated to include warnings about ONJ.

]]> Dentists concerned about cases of decaying jaw bones http://www.yourlawyer.com/articles/read/12411 Tue, 19 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12411
The technical name for dying jaw bone is osteonecrosis of the jaw , known as ONJ. Symptoms, which may take weeks or months to appear, include pain, loose teeth, exposed jaw bone in the mouth and drainage, according to the American Dental Association Web site.

The drugs being linked to the condition are known as bisphosphonates. They include Fosamax, Actonel and Boniva, which come in pill form, as well as other bone-strengthening medications given through IVs. The oral drugs are often prescribed for osteoporosis patients. The IV versions are more commonly prescribed for patients dealing with cancers that may attack their bones.

“This is a big topic with us right now,” said Terre Haute dentist Dr. Aaron Luttrell, president of the Western Indiana Dental Society.

The ADA is warning dentists to avoid “invasive dental procedures” in patients on IV bisphosphonates and is recommending a “conservative” approach to dental procedures for any patients using oral bisphosphonates. The organization also recommends anyone planning to begin taking bisphosphonate therapy have any dental procedures done before taking the drugs.

Some cases of ONJ have appeared after someone using bisphosphonates has had a tooth pulled or some other dental procedure, but other cases have appeared “spontaneously,” according to a recent article in Dental Economics.

“We’ve seen about five or six patients” with ONJ, said Dr. Michael Deady, a Terre Haute-based oral surgeon. All his patients were on oral bisphosphonates, mostly Fosamax, he said. Some of the cases appeared linked to previous dental procedures, others appeared “spontaneously,” he said.

“Experimental data is a little bit lacking,” on how exactly bisphosphonates are linked to ONJ, said Dr. Don-John Summerlin, a professor of oral and maxillofacial pathology at the IU Medical Center in Indianapolis. “There’s a lot we don’t know yet,” he said.

One prominent theory, however, holds that because bisphosphonates impede cells in the body that remove old bone tissue while allowing cells that add new bone tissue to continue to function as usual, a patient’s bones “become denser and denser,” Summerlin said.

And while this makes bones tougher to break, it may also make it more difficult for them to heal or naturally rebuild themselves, especially after a dental procedure such as a tooth extraction, according to James H. Foulkes, a Terre Haute dentist and former president of the Academy of General Dentistry.

Why the problem affects jaw bones and not so much other bones may be because of the “unique” quality of that bone, according to Luttrell. The jaw bone breaks down and rebuilds itself more than other bones, he said.

“As far as the dental profession is concerned, there is a definite link [between ONJ and bisphosphonates] and there is no question about that,” Foulkes said. “Our controversy is how to deal with it.”

Lawyers are seizing on the data linking Fosamax a best selling osteoporosis drug and other bisphosphonates to ONJ and are advertising to represent ONJ patients who have taken bisphosphonate drugs, whether orally or through an IV. Locally, at least one firm is advertising for such clients.

As of May of this year, Merck and Co. Inc., the pharmaceutical company that makes Fosamax, reported 15 ONJ-related lawsuits had been filed against it, according to CNNMoney.com. In one case, “seven figures” are being sought in damages, CNN reported.

Of the more than 20 million Americans using oral bisphosphonates, the number of reported cases of ONJ seems still to be in the hundreds or few thousands. As of May 2005, just 800 cases had been reported to the FDA, according to Medscape Medical News.

ONJ is “extremely rare,” said Merck spokesman Skip Irvine. “Merck estimates the worldwide cumulative reporting rate … is less than one [case] in 100,000 patient treatment years,” he said.

Merck did a 10-year clinical trial of Fosamax before winning FDA approval in 1995. In that trial, involving 17,000 patients, no cases of ONJ were reported, Irvine said.

But this does not have area dentists sleeping any easier.

“I don’t know how many people really know what’s going on,” Deady said when asked about the low number of reported cases. “If I’ve seen six cases. It’s pretty scary,” he said.

“We’re afraid it may be the tip of the iceberg,” Foulkes said. The fact that the population is aging and more and more people are using bisphosphonates to not only treat but sometimes to try and prevent osteoporosis, means it’s possible more cases may be just over the horizon, he said.

“Intuitively,” IU’s Summerlin said, he believes the risk of ONJ is increasing, but, he adds, he has no data to say that “factually.”

“I would say ‘don’t panic,’” Summerlin said. And, in the case of cancer patients using IV bisphosphonates, he believes the risk of some bone loss is probably greatly outweighed by the benefits of the drugs.

“I don’t think anyone can produce absolute data saying how significant the problem is. I think it is a minority of the patients that have this problem,” but even a small percentage of the millions using bisphosphonates “could be a large number of people,” he said.]]> Jaw disease may be linked to osteoporosis drugs http://www.yourlawyer.com/articles/read/12034 Mon, 31 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12034
Almost 95 percent of the known cases have occurred among cancer patients taking the drugs, called bisphosphonates, prescribed intravenously at doses often more than 10 times than recommended for osteoporosis. Most of the time, the condition called osteonecrosis of the jaw has followed dental surgery or tooth extraction, but in some instances, the problem has emerged spontaneously.

Doctors reported the first case in 2003, and since then, about 400 instances have been described in medical journals. However, no one really knows how often it occurs. Compared with the number of people taking the drugs, the risk appears very small. Even if the number affected stretches into the thousands, in 2005 alone, more than 22 million prescriptions were dispensed for Fosamax, the most popular oral bisphosphonate.

"I still feel that they're pretty safe drugs," said Dr. Elizabeth Shane, a specialist in bone diseases at Columbia University, and president of the American Society for Bone and Mineral Research. "It's extremely important to remember that doctors prescribe bisphosphonates for a reason."

People with cancer use bisphosphonates to help reduce bone pain, protect against overloads of calcium in the blood, or help control malignancy that has spread to the skeleton. Those with osteoporosis use them orally, in much lower doses, to help prevent painful and sometimes deadly fractures.

Still, Shane said, some people getting the drugs have become fearful. "My anecdotal experience is that people are terrified, and they're stopping these drugs," she said. "The incidence is still very low, especially in patients just taking the oral medicine."

To address the many unknowns about the condition, Shane and the bone and mineral research society has assembled a group of experts in bone diseases, dentistry, epidemiology, and other areas to examine the condition.

Although infrequent, osteonecrosis in the jaw can become devastating if it appears. Two-thirds of the time, patients are tormented by pain that can be severe, according to a recent summary of knowledge published in the Annals of Internal Medicine. Affected patients can have mouth ulcers that won't heal and sores that reach to the skin.

Treatment for the condition is unclear.

"There's really no good management," said Dr. Jenny He, a specialist in bone metabolism and endodontics at Baylor College of Dentistry-Texas A&M Health Science Center in Dallas. "Patients usually need to go on very long term antibiotic treatment."

If doctors know little about treatment, they understand even less about why it occurs. Bisphosphonates work by targeting the cells that constantly remodel internal bone structure. The engines of this turnover are cells called osteoclasts that clear away old bone, and cells called osteoblasts that form new bone in its place. Bisphosphonates slow the work of osteoclasts, but by doing so, also affect osteoblasts because the two work in tandem.

The jaw is particularly abuzz with bone turnover due to microscopic injuries that occur from constant use. One theory, though it is just a theory, is that the suppression of churn from bisphosphonates keeps the jaw from repairing itself after an injury such as tooth extraction. Also, the mouth is teeming with bacteria that are separated from bone by the thinnest of barriers.

For now, the best guidance physicians and dentists offer is prevention. Patients taking bisphosphonates should be keenly aware of oral hygiene and routine dental care. If someone is about to go on the drugs, dentists say necessary invasive dental work should be done beforehand, if that's possible. Delaying the drugs for the sake of dental work should also be weighed against the risks of delaying therapy.

If invasive dental work is unavoidable for someone already on bisphonates, the advice is less clear. The drugs have a remarkable ability to huddle inside the bone for years, so they will persist long after a person stops taking the pills.

For that reason, Dr. John Kalmar says that patients may talk with their physicians about going off the drugs in the months before needed dental procedures. Kalmar, an expert in oral surgery and pathology at Ohio State University, was senior author of the Annals of Internal Medicine report summarizing known facts about osteonecrosis.

"Data will tell you that the density of the bone stays the same for several months up to a year after stopping the drug," Kalmar said.

No one knows whether a drug holiday would help reduce the risk of jaw osteonecrosis, but Kalmar says it seems unlikely to do harm. He would also like to see investigation into the effects of pulsing the drugs stopping and starting them at various intervals rather than taking them continuously for years.

"There's so much that's unknown," he said. "The best you can do is say `This is what makes sense.'"

Kalmar and others say that until medical science offers more answers, concerned patients should talk to their doctors, but not abruptly abandon the medications. "The benefit of using these drugs is so overwhelming," said Baylor's He, "you shouldn't stop taking these drugs just because of concern about this."]]> BONE-DENSITY DRUGS CAN KILL JAWS http://www.yourlawyer.com/articles/read/11958 Wed, 05 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11958
Do you take a bone-building medication such as Fosamax?

These widely used drugs, called bisphosphonates, have recently been linked to a rare side effect that causes parts of the jawbone to deteriorate and die.

The bulk of the 3,000 published cases of jaw osteonecrosis meaning "dead bone" have occurred after dental procedures, mostly in cancer patients on intravenous bisphosphonates. But the problem has also developed out of the blue in otherwise healthy people taking bisphosphonate pills to boost bone density.

"If you're going to be on this drug, make sure you really need it," said Alan Meltzer, a Voorhees, Pa., periodontist.

Since 2003, when the first 36 cases were described in a medical journal, the Food and Drug Administration has required all bisphosphonate labels to include a precaution, hundreds of lawsuits have been filed against drug makers, and expert dental groups have issued advice for managing the tens of millions of people now on the drugs.

Still, there are no good treatments for what specialists have begun calling "bisphossy jaw." Nor is it clear that quitting the drugs reduces the risk because bisphosphonates can persist for years in the bone. The incidence, variation and progression of the jaw disease are also unclear.

"What we have seen and heard from health-care givers is that more and more people are showing up with milder forms, so the true incidence rate now is anybody's guess," said John R. Kalmar, an Ohio State University oral pathologist and author of a May review article in Annals of Internal Medicine. "We're telling people to be cautious."

The advent of bisphosphonates about a decade ago was a boon for people whose bones were riddled by cancer treatment, osteoporosis or a disorder called Paget's disease. Since 1995, 191 million prescriptions have been filled for oral Fosamax, Actonel and Boniva, plus millions more for intravenous Zometa, Aredia and generic Pamidronate.

For healthy people seeking to boost bone density, the risk of jawbone death appears to be remote; the estimate from Fosamax maker Merck & Co. is less than one out of 100,000 patients per year.

On the other hand, many postmenopausal women taking the pills may not really need them. Low bone density does not automatically progress to osteoporosis, and even when it does, a debilitating fracture is not inevitable.

Crystal Baxter, a former University of Pittsburgh professor of prosthodontics who now practices in Arizona, said she is very leery of doing elective dental implants in patients who have taken oral bisphosphonates.

"The scary thing," she said, "is that these drugs are being marketed to practically every aging woman in the world."

It has become clear through trial and terrible error that trying to fix bisphossy jaw with invasive dental procedures only makes it worse.

Ruth Ann Dutton, 66, for example, went to her regular dentist after a shard of bone spontaneously broke through her gum. Although she had taken Aredia and Zometa for advanced breast cancer, the splintering of her jaw was not triggered by a dental procedure.

"He did a root canal, but it never got better," she said.

A year ago, she was referred to Meltzer, who prescribed antibiotics and antiseptic rinses.

"Right now, it's doing pretty decent," she said. "The hole is mostly closed up."

Barry Levin, an Elkins Park periodontist, said one of his elderly patients has not been as fortunate. She quit Fosamax after tooth extractions led to a diagnosis of osteonecrosis, but bone grafted to her damaged jaw has not healed properly.

"It's been a nightmare," Levin said.

Bisphosphonates build bone by tamping down the normal turnover of bone cells. Kalmar and other experts speculate that osteonecrosis develops when the drugs are too effective at suppressing bone regeneration.

Why hasn't the problem shown up after, say, hip replacement surgery? Experts say the jaws are particularly vulnerable because cells turn over faster there than in other bones. Jaws are also constantly exposed to minor trauma from chewing, and to bacteria from the mouth.]]> Another Merck Drug Is Under Legal Attack http://www.yourlawyer.com/articles/read/11959 Wed, 05 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11959
The emerging litigation targeting the osteoporosis drug, still in its early stages, illustrates how quickly lawyers can organize themselves and assemble prospective plaintiffs after reports of adverse drug effects even when those problems appear to be relatively rare.

Reports in the last few years have linked Fosamax and similar drugs, known as bisphosphonates, to a serious side effect in which the jawbone partially crumbles and dies. Researchers agree that the incidence of this problem, called osteonecrosis, is quite small.

But trial lawyers are advertising on the Internet and in newspapers for patients who have taken Fosamax or the other drugs, and they are finding potential clients.

"We're getting people calling every day," said a lawyer in Minneapolis.

This attorney said his firm had enlisted medical and dental experts to thoroughly review the records of potential plaintiffs who have taken one of the drugs, adding that he would probably file about 20 cases in the coming months.

"It's too early to tell whether these cases will be successful," said a San Francisco defense lawyer who represents drug makers. "But as soon as there is publicity about any kind of possible problems with a medication, the plaintiffs get geared up."

Merck spokesman Skip Irvine says that Fosamax is safe and effective in treating osteoporosis and that the company "will vigorously defend ourselves against these suits."

"Osteonecrosis is very rare and not well understood," Irvine said, noting that in controlled clinical trials involving more than 17,000 patients, there had been no reports of the malady.

Ethel Siris, a professor of medicine at Columbia University College of Physicians and Surgeons who has also consulted for Merck, said new research studies were underway to understand what triggers the onset of this jaw problem.

In the meantime, she said, she tells her osteoporosis patients that the benefits of the bisphosphonate drugs greatly outweigh their risks.

Fosamax is probably the best-known brand-name drug for preventing hip fractures and deteriorating bones that often destroy the quality of life for older women.

Millions of women have taken the drug since it was first marketed in 1995. Fosamax generated $3.2 billion in sales last year, outstripping the other major oral osteoporosis remedies, Actonel, produced by Procter & Gamble Co. and Sanofi-Aventis, and Boniva, made by Roche Laboratories.

Scientific reports of jaw problems have generated a wave of newspaper articles that in turn have sown panic among users of the drugs.

Many have turned to their doctors or dentists for advice on how to prevent jaw decay and the best treatment options. Last month, the American Dental Assn. released a set of treatment guidelines.

Some users have turned to lawyers as well.

One Florida attorney, has filed 30 damage suits involving Fosamax and expects to file at least 300 more over the next few months involving that drug as well as Actonel.

One of his clients is Rochelle Kenig, who took Fosamax for nine years until she woke up one morning in 2004 with "excruciating, excruciating" pain in her jaw.

"This has been a living nightmare, and nobody knew anything about it," the Boynton Beach, Fla., resident recalled.

Kenig, 67, said she underwent multiple courses of potent antibiotics, repeated surgeries, treatment in a hyperbaric chamber and acupuncture. Yet the pain and bone deterioration continued, she said.

She finally got some relief in April after a new group of surgeons replaced part of her jaw with a titanium plate secured with metal hinges. But, Kenig said, the decay and infections had caused a permanent loss of sensation on the right side of her lip and face, as well as the loss of several teeth.

Merck's Irvine declined to comment on Kenig's claim, adding, "We don't want to argue cases in the newspapers."

The attorney in Florida has asked a Florida federal court to certify a class action for the Fosamax suits. He estimated that he and other lawyers had filed a total of 50 lawsuits with possibly hundreds more to come.

Two bisphosphonates produced by Novartis Pharmaceuticals Corp., Aredia and Zometa, are given intravenously in treating some forms of bone cancer. The drugs have also been targeted in lawsuits from about 100 claimants to date.

Some experts see the relatively slow pace of lawsuit filings against Fosamax and its related drugs compared with the flood of Vioxx suits that followed Merck's decision to pull the drug in 2004 as evidence that plaintiffs' lawyers have become more cautious in recent years.

Litigation involving silicone gel breast implants and Bayer's cholesterol-lowering drug Baycol proved less successful than lawyers initially expected, said Francis McGovern, a Duke University law professor.

"Now, you might take a particularly good case and see how good it is before you take lots of others and invest a lot of money," McGovern said.

Drug makers are also taking more precautions. Merck added language about the potential problem to Fosamax's label in July after a request from the Food and Drug Administration, which had reviewed reports of osteonecrosis, Irvine said.

The revised label "communicates the issue clearly to physicians," Irvine said.
]]> Fosamax risk weighed http://www.yourlawyer.com/articles/read/11903 Mon, 19 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11903
“You take Fosamax,” he said, studying her medical history form.

“Yes, I do,” she replied.


He walked around the chair, as if he was going to break bad news to her, she recalled.

Then he did.

He told her that Fosamax, which she took to stave off the bone-weakening disease osteoporosis, was one of a class of drugs called bisphosphonates implicated in a serious bone disease. In a small number of cases, after tooth extraction or implant placement, the bone failed to heal, remained exposed or became infected.

Called osteonecrosis of the jaw, or ONJ, it was first linked to bisphosphonates by a Miami dentist in 2003. No cases were reported in any of the clinical trials done before the drugs went on the market, but Dr. Robert E. Marx noticed ONJ among 36 cancer patients who were taking intravenous versions of the drugs. The medications were prescribed to prevent fractures and ease pain caused by cancer that had spread to their bones.

Case reports continued to crop up, including 15 patients who were taking oral forms of the drug to prevent osteoporosis. A May article in the Annals of Internal Medicine reviewing previously published reports said 94 percent of patients who developed ONJ were being treated for metastatic cancer with IV bisphosphonates. Sixty percent of patients had a dental procedure done before ONJ was diagnosed.

The risk for people undergoing oral surgery while taking oral bisphosphonates, such as Fosamax, Boniva and Actonel, is unknown, the article’s authors said, but for people like Ms. Korch contemplating elective oral surgery, any risk was too high.

“It was very shocking,” she said. “You can’t really minimize it because there’s no cure for this.”

Her orthodontist and dentist devised a plan to perform a root canal, after which the tooth, no longer connected to the bone, will come out like a baby tooth. In that way the bone would not be affected and her orthodontia to correct severe crowding could continue.

That will solve her immediate problem, but she still decided to stop taking Fosamax.

Medical experts, including the National Institutes of Health, haven’t gone that far. The National Institute of Arthritis and Musculoskeletal and Skin Diseases calls cases linking these oral drugs to ONJ rare. Its Center for Clinical Research is planning research into the question.

The Food and Drug Administration has ordered the makers of bisphosphonates to list ONJ in its precautions on package inserts.

Dr. Meryl S. Leboff, director of the skeletal health and osteoporosis program at Brigham & Women’s Hospital in Boston, also calls the risk low.

“We really don’t know the true incidence of this problem worldwide, but the risk in patients who are treated with oral bisphosphonates is very, very low. Low, but not zero,” she said. “It’s important for physicians to work with dentists and oral surgeons and that patients really try to optimize their dental hygiene.”

Osteoporosis the disease the drugs target affects 10 million Americans, leading to fractures for one out of two women and one out of four men over 50 in this group, according to NIAMSD.

About 34 million Americans, both men and women, have low bone mass, putting them at risk for osteoporosis. Being older, female, Caucasian or Asian, and having a family history of osteoporosis puts people at higher risk. Other factors estrogen and testosterone levels, physical activity, diet, medications, alcohol, cigarettes also come into play.

Low bone mass occurs when the process of old bone being renewed (resorption) and new bone being formed (formation) changes. Up until about age 30, formation outpaces resorption. After that the ratio shifts. Bone loss can eventually lead to osteoporosis.

Bisphosphonates prevent bone loss by inhibiting resorption of old bone and interfering with the bone formation. Scientists theorize that ONJ may occur after oral surgery in patients taking bisphosphonates because the drugs thwart the bone resorption needed for healing. Another possible explanation is that the drugs prevent formation of new blood vessels, causing the bone tissue to die.

Whatever the mechanism, there is no cure for ONJ. And bisphosphonates do stay in the body for years after a person stops taking them. In a position paper published last year, the American Academy of Oral Medicine said prevention was the best approach.

“The message needs to be that anyone considering Fosamax should really get their dentistry straightened out because of the risk of osteonecrosis,” said Dr. Stanley M. Levenson of Worcester, who is Ms. Korch’s dentist and agreed when her oral surgeon would not extract her impacted tooth. “She was lucky that wasn’t something she had to do.”

Some 23 million Americans take oral bisphosphonates for osteoporosis, according to the American Dental Association. And some of them need to have infected teeth extracted.

Dr. Shay Shen, a Worcester oral surgeon, said he looks at whether a patient is taking oral or intravenous bisphosphonates and at how high a dose.

“But if the tooth really needs to be removed and there’s no other way of doing it, we still go ahead and remove the tooth,” he said. “It’s not an absolute contraindication that you cannot take a tooth out if a patient is taking Fosamax.”

Patients are put on antibiotics to prevent infection after oral surgery.

Ms. Korch, who gives her age as “45-plus,” attributes her low bone mass to her small stature, European heritage and family history.

“I am in good health other than issues with bone density. If you had the option of the possibility of developing an irreversible, excruciatingly painful, disfiguring disease, would you take that chance?” she asked in a chat room on www.archwired.com, a site for adults wearing braces.

Dropping a medication is not new to her. She was on hormone replacement therapy until the Women’s Health Initiative clinical trial was halted in 2002 because of an increased risk of heart attacks and stroke that outweighed the benefit of bone strength. She said she is frustrated by the lack of information on Fosamax at this point, but plans to stay off the drug at least until her alternative to tooth extraction is completed.

“It’s everybody out of the pool again,” she said.
]]> Bone-building drugs linked to bone-rotting side effect http://www.yourlawyer.com/articles/read/11867 Tue, 13 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11867
An elderly woman was complaining about soreness caused by her dentures, but there was nothing Erlichman could do to relieve her pain. That's because she suffers from a rare jawbone disease that is increasingly being linked to a group of drugs for osteoporosis and cancer. And he noted she'd been taking one of those drugs for several years.

"There's more concern about this all the time now," said Erlichman, an oral surgeon in Little Falls. "The drugs are known to truly help people, but they can also cause the jawbone to become inert to the point where you can't drill a cavity or perform an implant.

"You can't do anything with these patients. And I worry about others developing the problem."

Each year, millions of Americans seeking to ward off brittle bones take pills that belong to a class of medicines called bisphosphonates. By far, the most popular pill is Merck's osteoporosis drug, Fosamax, which has been available for a decade. A much smaller number of patients receive an intravenous version of the medication as part of their chemotherapy.

To date, the incidence of drug-induced jawbone disease remains rare. Researchers report fewer than 400 cases of the disease, known as osteonecrosis, a painful and debilitating condition that essentially rots the jawbone. And the vast majority of these cases 94 percent are associated with a pair of intravenous medicines sold by Novartis, according to an article last month in the Annals of Internal Medicine.

Nonetheless, oral surgeons and dentists are increasingly worried the number of cases will multiply, and warnings have been posted on Web sites run by their professional groups. The problem, they say, is that bisphosphonates remain in the bones for years. Given that more prescriptions are written each year for the pills, which include Actonel and Boniva, experts suggest the rate at which osteonecrosis will be diagnosed is likely to increase.

"The concentration in the bones begins to build up by the third year. So it's not surprising that we're starting to see more cases among people who take the pills," said Robert Marx, who chairs the oral and maxillofacial surgery department at the University of Miami medical school, and who first sounded the alarm about the problem three years ago.

Although Fosamax has been prescribed since 1995, usage grew dramatically about five years ago, which Marx said would explain why cases linked to that pill are only now being diagnosed. Actonel has been available since 2000, and Boniva was launched last year. Marx said he doesn't expect to see as many cases associated with those pills right now.

Marx believes Merck researchers didn't anticipate the extent to which bisphosphonates can effect the jaw compared with other bones. In his view, the Fosamax clinical trials should have looked for the problem. If they had, Marx said, "they could've predicted this might have occurred."

A Merck spokesman responded that Fosamax is linked to a very small number of cases compared with the millions of people who have taken the pill. In 1997, for instance, 1.5 million new prescriptions were written for Fosamax; that figure jumped to 4.5 million by 2002, but slid to 4.2 million last year, according to Verispan, a market-research firm.

The idea that greater use will result in an increased risk of osteonecrosis "isn't substantiated by the current data," Merck spokesman Chris Loder wrote in an e-mail. "To suggest so would be misleading and incorrect." But at the request of regulators, Merck last year changed Fosamax labeling to mention osteonecrosis has been reported among patients taking bisphosphonates.

Two studies about to be published are expected to substantiate that view, according to the lead author, Marjorie Jeffcoat of the University of Pennsylvania dental school. One study traced 320 Fosamax patients for two years and the other tracked 80 Fosamax and Actonel patients for five years.

"The data didn't show a cause and effect," said Jeffcoat. However, she noted the data didn't provide a definitive answer about whether a bisphosphonate pill could cause osteonecrosis if taken for a lengthy period of time.

The Merck spokesman added that no cases of osteonecrosis were found among 17,000 patients in its clinical trials, although he acknowledged the company has received side-effect reports. However, he argued these reports "do not necessarily indicate causality," declined to provide the number of side-effect reports received.

An FDA spokeswoman, Laura Alvey, said she could not immediately provide the number of side-effect reports the agency has received involving bisphosphonates and osteonecrosis.

Paula Koenigs, a spokeswoman for Procter & Gamble, which markets Actonel with Sanofi-Aventis, said there is no scientific study that concludes bisphosphonates cause osteonecrosis, and the jawbone disease wasn't seen in clinical trials.

Maureen Byrne, a spokeswoman for Roche, which jointly markets Boniva with Glaxo, said osteonecrosis wasn't seen in trials.

Nonetheless, the growing concerns about osteonecrosis are prompting lawsuits against the drugmakers. So far, Merck faces at least 15 lawsuits over Fosamax, while two have been filed against Procter & Gamble and Sanofi-Aventis.

One Florida lawyer, who is in the process of filing additional lawsuits against Merck, argued the company has failed to properly warn patients. He maintained that despite a 2004 report by the FDA's Office of Drug Safety, Merck hasn't added meaningful language in the Fosamax label to specifically indicate the risk of osteonecrosis.

"They never come out and say it's a risk factor," said Tim O'Brien, who noted that Novartis is so far the only company to have sent letters to doctors about the risk. "You have to read between the lines (of the product labeling) and read the medical literature to understand what they actually are saying. It's very misleading."

He added the FDA has cited Merck for being too aggressive in promoting Fosamax. The agency sent four letters between 1997 and 2001 for making unbalanced or misleading claims in promotional brochures or consumer advertising.

Lawsuits alleging damaging side effects caused by prescription drugs are increasingly common. The Vioxx scandal has generated more than 11,500 lawsuits against Merck. By comparison, the number of Fosamax lawsuits is minuscule, but the specter of more bad publicity doesn't thrill Wall Street.

"This is definitely a headache that the big drugmakers, especially Merck, don't need," said David Moskowitz, an industry analyst at Friedman Billings Ramsey, who noted Fosamax generated $3.2 billion in sales last year. "Merck has few growth drivers, and they can't afford for Fosamax to sustain too much damage."

One solution might crimp Fosamax sales. Hillel Ephros, who chairs the dentistry department at St. Joseph's Regional Medical Center in Paterson, wants doctors to consider alternatives before writing prescriptions for the pills.

"Everyone needs to know that osteonecrosis can't be fixed," said Ephros, who has seen seven cases of the disease. "The problem makes me feel shackled and frustrated. We have to defer and postpone procedures for patients on oral bisphosphonates, and the day may come when I will decline altogether. Maybe that can be prevented."

The drugmakers are advertising their pills widely. Last year, they spent $174.3 million, up from $54.8 million in 2003, according to TNS Media Intelligence, a market-research firm. That's because Boniva was launched last year with a big promotional effort, prompting Procter & Gamble and Sanofi-Aventis to spend more on Actonel.

One doctor suggests ads should explicitly and prominently mention the possibility the pills can cause osteonecrosis. Salvatore Ruggiero, chief of oral and maxillofacial surgery at Long Island Jewish Medical Center in New Hyde Park, N.Y., believes the risk of developing osteonecrosis is "very small," but few know it exists.

"The problem has taken a long time to manifest itself, and so I think it'd be unfair to say these drug companies expected this to happen. That'd be a real stretch. The lawyers are creating a perception that it's a big problem," he said. "But we need to realize that there is this side effect. And it needs to be better known."

For Mary Kyle, the debate is taking place too late.

A retired elementary school teacher who lives in Mount Laurel, Kyle said she was prescribed Fosamax four years ago to prevent osteoporosis, but recently was diagnosed with osteonecrosis after complaining of jaw pain. Last week, she filed a lawsuit against Merck.

"I was told I'll have this problem for the rest of my life," said Kyle, 58. "My oral surgeon couldn't give me much hope there's anything he can do. Now, I want to educate others. There are a lot of people on this drug and this problem may happen to them, but they may not know the drug is causing the problem."
]]> Bone drug may hold hazards http://www.yourlawyer.com/articles/read/11740 Sat, 20 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11740
But a growing number of physicians and oral surgeons have raised concerns that the long-term use of Fosamax, and similar so-called "bisphosphonates," can lead to "dead jaw" syndrome, a painful condition that causes ulcers, tooth loss and exposed bone.

Researchers say cases are rare and seem most common among patients receiving intravenous bisphosphonates such as Zometa or Aredia in conjunction with chemotherapy or radiation for breast cancer and multiple myelomas. Incidents also appear more likely to follow serious dental surgery, such as a tooth extraction.

But while cancer patients appear more at risk, Dr. Bruce Pihlstrom of the National Institutes of Health said some patients taking standard oral doses of bisphosphonates for osteoporosis also developed the condition technically called "osteonecrosis," a word that literally means "dead bone."

"Patients need to be aware of the risk," said Pihlstrom, a clinical research director specializing in dental and cranial-facial work. "If I was taking these drugs, I would make sure I had the best dental health care I could get."

Pihlstrom said NIH plans to fund new research to quantify the potential risks of bisphosphonates.

The American Association of Endodontists, which deals with conditions inside the tooth, issued a statement several months ago, advising precautions for patients on such drugs and urging dentists to report all cases to the Food and Drug Administration. Pihlstrom said he so far knew of 368 reported cases.

About 44 million Americans, almost 70 percent of them women, have low bone density or osteoporosis. Fosamax, manufactured by Merck & Co., is the world's best-selling osteoporosis medication. More than 22 million prescriptions were written for Fosamax in this country last year, according to pharmaceutical research firm IMS Health, and the drug has about $3 billion annually in sales.

Rochelle Kenig, who lives west of Boynton Beach, had no second thoughts about starting on Fosamax 10 years ago when a bone-density test showed she was in the early stages of osteoporosis.

In September 2004, Kenig began having excruciating pain in her right lower jaw. Her jaw swelled, and she developed an infection that required intravenous antibiotics. A maxillofacial surgeon finally told her in May 2005 that she had osteonecrosis.

Kenig's doctor told her to stop the Fosamax immediately.

Earlier this year, Kenig had a portion of her jaw removed, followed by a graft to fill a hole in her rotting jaw bone.

"I don't want this to happen to anyone else. And I'm angry it happened to me," said Kenig, 67.

Kenig is part of a class action lawsuit filed in U.S. District Court in Fort Myers last month. The suit represents about 300 people nationwide. All were formerly on Fosamax and none were cancer patients.

The suit will ask the court to set up medical monitoring and pay for treatments and surgery for osteonecrosis patients.

In a statement released last month, Merck stated that "in all of our controlled clinical trials which have included more than 17,000 patients, we have not had reports of osteonecrosis of the jaw occurring in patients taking Fosamax." The company said it complied with FDA requests last year and includes updates about osteonecrosis risk both in packaging inserts and product information sent to physicians.

But Dr. Michelle Fiorillo, a family physician with the Holy Cross Medical Group in Fort Lauderdale, doesn't remember seeing any such warnings and said the representative promoting Fosamax never mentioned them.

Now she says she's carefully monitoring her patients who have been on the medication for years. Diagnosing a woman with osteoporosis this week, Fiorillo placed her on a low-dose estrogen patch instead of Fosamax when she learned the woman had dental problems.

The connection between jawbone death and bisphosphonate use is difficult to track, Fiorillo said, because it's physicians who prescribe the drug but dentists who treat the result. And switching patients off bisphosphonates will do little good immediately, Fiorillo said, as the drug has a long half-life it can continue to effect the body's bone-building properties for six to 12 years, researchers think.

"This definitely is changing the way I prescribe for my patients with osteoporosis," Fiorillo said.]]> Painful jaw decay tied to osteoporosis drugs http://www.yourlawyer.com/articles/read/11685 Fri, 05 May 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11685
Health Canada is adding new warnings to the medications, called bisphosphonates, which are taken to protect and strengthen bone.

In rare cases, first described three years ago, bisphosphonates can cause jaw bones to rot and die.

Jaw necrosis affects up to 10 per cent of people who take bisphosphonate drugs, experts. say. Most have metastatic cancer and have been injected with potent drugs to protect their bones.

Gwen Davis-Wells, 62, who has multiple myeloma and takes the bisphosphonate drug Aredia to protect her bones, said she was shocked when doctors told her they thought the drug was causing the problem with her jaw bone.

Doctors have since prescribed a liquid diet for her, saying her jaw is very thin and getting worse.

"When I'm at church and we're giving the peace sign, I can't let people give me a kiss on the jaw, hug me too tight, because these little things could cause it to break," said Davis-Wells.

About 10 per cent of cases are caused by oral bisphosphonates such as Fosamax or Actonel. Women may take the drugs to prevent or treat osteoporosis, a bigger market for medications.

Last year, doctors in Canada wrote five million prescriptions for oral bisphosphonates.

"Worldwide, to our knowledge, there are only 35 reported cases in millions and millions of individuals who've received these drugs for the management of osteoporosis," said Dr. Gillian Hawker, a rheumatologist at Women's College Hospital in Toronto.

The risk of jaw necrosis seems to be linked to the dose, and how long people take it, said Dr. Maico Melo, an oral surgeon at Washington Center Hospital who is treating Davis-Wells.

Osteoporosis is expected to become more common among Canada's aging population. The concern is, as more people are prescribed bisphosphonates at an earlier age, more cases of jaw necrosis will surface, Melo said.

People who are on the drugs are advised against having invasive dental surgery, as it seems to increase the risk, doctors say.]]> Merck sued over Fosamax http://www.yourlawyer.com/articles/read/11544 Thu, 13 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11544
According to a lawsuit filed Monday in U.S. District Court in Fort Myers, Fla., Fosamax is a defective product because it can cause osteonecrosis of the jaw, or a rotting of the jaw bone. The suit, which seeks class action status, alleges that Merck concealed and continues to hide Fosamax's potentially dangerous side effects from patients and doctors.

Fosamax is Merck's second best-selling drug with last year's revenue essentially flat at $3.2 billion.

In a statement, Merck said that in all of its clinical trials of Fosamax, which have included more than 17,000 patients, it has not had any reports of osteonecrosis of the jaw. Merck said that there have been reports of patients taking Fosamax developing the condition but that doesn't necessarily mean the drug caused it.

The lawsuit alleges that the U.S. Food and Drug Administration asked Merck to add a warning to Fosamax's label in August of 2004 and that it has yet to comply with that request.

Merck counters that it received a request from the FDA to update the label with information about the condition in January 2005. It says that by July 2005 information regarding the problem was on the label.

But Tim O'Brien, who filed the suit, said the information in the label isn't an adequate warning.]]> Merck's Fosamax next legal battleground? http://www.yourlawyer.com/articles/read/11540 Wed, 12 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11540
That according to a Wall Street Journal report Wednesday, which said that Merck's top-selling osteoporosis drug Fosamax is the second drug made by the embattled company to come into the crosshairs of the medical tort bar. A lawsuit was filed this week in Fort Myers, Fla., the report said, with the plaintiffs seeking class-action status.

According to the WSJ, the suit alleges Fosamax caused a rare disorder called osteonecrosis, in which the patient's jawbone "rots and dies." A similar suit was filed in Tennessee last fall, the report said.

Following the legal strategy used in the widely publicized Vioxx-related cases brought against Merck, the Florida-based Fosamax suit alleges that Merck "heavily marketed" Fosamax as safe despite the risk of the rare side effect.]]> Clinton woman suing Merck over problem with Fosamax http://www.yourlawyer.com/articles/read/11543 Wed, 12 Apr 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11543
As many people know, Merck is already facing a flood of lawsuits over its drug Vioxx. But another problem with a different drug seems to be emerging.

The osteoporosis drug Fosamax is under fire, with reports linking its long term use to a condition causing patients' jawbones to rot and die. That disease is called osteonecrosis (ONJ) and it caused problems for Gwendolyn Wolfe.

"A substantial portion of her jawbone had to be removed and Dr. Carlson did that in surgery," says Wolfe's attorney. "She's still having significant pain and will for the rest of her life."

Her attorney has filed a lawsuit seeking class action certification claiming Fosamax has injured countless patients around America and. The suit also claims Merck knew about the problems but failed to report them.]]> Jaw Complications May Be Linked to Bone-Saving Drugs http://www.yourlawyer.com/articles/read/10118 Wed, 22 Jun 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10118
So the Nebraska City woman travels each weekday to Omaha, where doctors put her in a pressure chamber in which she breathes pure oxygen, in hopes of helping her jaw heal.

What left her with a sharp, exposed piece of jawbone isn't clear. But after a friend gave her an article about puzzling cases in which patients had patches of jawbone die after similar procedures, Beckman suspects that it may have something to do with a drug she's taking. And she wants to warn others who might be at risk.

The patients in the article, like Beckman, took drugs called bisphosphonates. Most, like Beckman, were cancer patients receiving high intravenous doses to lower elevated blood calcium or prevent cancer from invading bone. A few were osteoporosis patients taking oral versions marketed under names like Fosamax and Actonel to strengthen bone.

"After I read it, I thought, 'Oh, dear,'" said Beckman, 65.

Although some doctors are beginning to share Beckman's suspicions, it's unclear whether the normally bone-saving drugs play a role in jawbone death. Some don't think there's a connection to osteoporosis drugs. The anecdotal cases and the roughly 875 reports that the IV drugs' maker had received by February from among millions of users point to a small risk among users.

The concern arises because use of the drugs, particularly for osteoporosis, is growing. Doctors don't know as much as they would like about the jaw condition and have few tools to treat it. The best way to prevent it, at least among cancer patients, may be to do a dental exam and repair any problems before treatment begins with the drugs.

"It's more of a public awareness and medical awareness issue," said Dr. Michael Miloro, chief of oral and maxillofacial surgery at the Nebraska Medical Center, who is treating Beckman.

Oral surgeons were among the first to notice the problem. In May 2004, a New York doctor reported seeing 63 patients with the jaw condition from February 2001 to November 2003.

Of those cases, 56 had received the IV drugs Zometa or Aredia; seven had been taking oral medications.

After a tooth is pulled, the bone typically remolds itself and fills in the gap. But the drugs inhibit cells that take away dead bone and clear the way for other cells to finish the rebuilding job.

An estimated 90 percent to 95 percent of the 875 cases have been in cancer patients taking the intravenous versions, said Dr. John Hellstein, clinical professor of oral and maxillofacial pathology at the University of Iowa.

A smaller number have shown up in osteoporosis patients, he said. He based his estimates on published reports, the cases he has seen and those he has discussed with other doctors.

But Dr. Robert Recker, director of Creighton University's Osteoporosis Research Center, said he isn't convinced that there's a risk associated with the osteoporosis drugs.

Recker has treated several thousand patients with oral bisphosphonates in clinical trials and in practice. He also has seen clinical trial data on the drugs as a member of scientific advisory boards for Merck and Procter & Gamble Pharmaceuticals, the respective makers of Fosamax and Actonel.

"I don't think there's any significant risk in patients who have osteoporosis," he said. "The risk is in patients who are taking giant doses for cancer."

No one is advising patients to stop taking the drugs, which produce clear benefits, Hellstein said. "You don't want to scare people not to take their osteoporosis medicine, because that would be a lot worse."

Novartis, which makes the intravenous drugs, has added inserts to package labels noting that it has received reports of the condition among patients taking the drug. The company sent a letter to dentists in May and has produced a brochure for cancer patients.

Merck, maker of Fosamax, is in discussions with the Food and Drug Administration about the matter. Procter & Gamble Pharmaceuticals plans to add precautions about the condition to Actonel's labels at the FDA's request.

Miloro said it's unclear whether the pressure chamber treatments will work for Beckman.

"I can't blame anyone," she said. "I just wish I'd known."]]> Drug Linked To Death of Jawbone http://www.yourlawyer.com/articles/read/9456 Sun, 13 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9456
Over a three-year period, the jaws of dozens of patients who had undergone oral surgery at his hospital had failed to heal properly. Part of the jawbone had died and become exposed.

"We never saw this before in the jaw" except in patients who had received radiation therapy to that part of the face, says Ruggiero, chief of oral and maxillofacial surgery at Long Island Jewish Medical Center. "It just never existed."

Further investigation revealed one common thread: All of the patients had been treated with at least one of a class of drugs called bisphosphonates.

Most were cancer patients who had received the intravenous bisphosphonates Zometa or Aredia or both for excessive calcium in their blood or bone tumors.

But about 10% were osteoporosis patients who had taken an oral bisphosphonate, mainly Fosamax.

In May, Ruggiero co-wrote a report on 63 patients with osteonecrosis or bone death of the jaw in the Journal of Oral and Maxillofacial Surgery. Six had taken Fosamax, and a seventh had taken Actonel, another oral bisphosphonate for osteoporosis.

The problem doesn't appear to be as severe with oral bisphosphonates as it is with the IV drugs, Ruggiero notes. Patients who have been receiving IV bisphosphonates should avoid having teeth pulled "at all costs," he says.

Based on his cases, a Food and Drug Administration review posted last week on the agency's Web site suggests that osteonecrosis of the jaw (ONJ) is a risk of all bisphosphonates, not just the IV drugs.

Bisphosphonates remain in bone indefinitely. Ruggiero speculates that their long-term use could upset the delicate balance between cells that put calcium in bone and cells that take calcium away.

The FDA review concluded that all bisphosphonate labels should mention osteonecrosis.

Novartis, maker of Zometa and Aredia, added a precaution about ONJ to their package inserts in August, although the inserts note that cancer patients have other osteonecrosis risk factors, such as their malignancies.

Merck spokesman Tony Plohoros says his company is in the process of adding information about the ONJ cases to the Fosamax label. And Terri Pedone, spokeswoman for Sanofi-Aventis, which markets Actonel with Procter & Gamble, says, "We are currently addressing the FDA's request to update the label" with information about ONJ.

Rugierro says he has now seen a total of 12 or 13 cases of ONJ in patients treated with an oral bisphosphonate. Robert Marx, chairman of the division of oral and maxillofacial surgery at Florida's University of Miami, says he's aware of at least 40 or 50 cases of ONJ nationwide in patients who had taken Fosamax.

That's a infinitely small fraction of the approximately 3 million women in the USA who are taking the drug, although most experts agree that only 1% to 10% of adverse events linked to drugs are reported.

Interestingly, some doctors have prescribed IV bisphosphonates "off label" for osteoporosis. And Roche and GlaxoSmithKline announced in December that they are seeking FDA permission to market an IV form of their oral bisphosphonate, Boniva, for osteoporosis.]]> Jaw Disease Found in Patients Using Cancer Drug http://www.yourlawyer.com/articles/read/9662 Fri, 04 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9662
The discovery, published in the Journal of Oral and Maxillofacial Surgeons, prompted both the US Food and Drug Administration (FDA) and Novartis, the manufacturer of bisphosphonates used in cancer chemotherapy, to issue warnings earlier this fall to physicians and dentists about the risk for this potential adverse effect.

ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma, such as a tooth extraction, causing the bone to be exposed. The exposure eventually can lead to infection and fracture, and may require long-term antibiotic therapy or surgery to remove the dying bone tissue.

Prolonged Use of Bisphosphonates Causes ONJ

The chief of the Division of Oral and Maxillofacial Surgery at LIJ, Salvatore Ruggiero, DMD, MD, and his staff reported that they were struck by the appearance of a cluster of cancer patients with necrotic lesions in the jaw, a condition they previously saw only rarely in one to two patients a year. When they launched a study of patients charts, they found that 63 patients diagnosed with this condition over a three-year period shared only one common clinical feature: They had all received long-term bisphosphonate therapy.

Bisphosphonates commonly are used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms are used widely in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures.

Several cancers can involve or metastasize to the bone, including lung, breast, prostate, multiple myeloma and others. In cancer chemotherapy, the drugs are given intravenously, and usually for long periods of time.

Disease Causes Traumatized Bone to Die Off

In their study, Dr. Ruggiero and his staff teamed up with Bhoomi Mehrotra, MD, in the Division of Hematology-Oncology at LIJ, and doctors in the Oral-Maxillofacial Surgery Division at the University of Maryland Medical Center.

Of the 63 patients diagnosed with ONJ between February 2001 and November 2003 at their centers, 56 were cancer patients who had received infusions of bisphosphonates for at least a year, and seven were non-cancer patients who had been receiving long-term oral therapy for osteoporosis.

The patients developed ONJ after normal bone trauma, such as a tooth extraction, while receiving bisphosphonate therapy. Rather than healing, the bone began to die, and the majority of patients required surgery to remove the diseased bone.

Early Diagnosis Key to Preserving Jaw Bone

In the FDA MedWatch and Novartis alerts issued in late September, oncologists and dentists were advised of the addition of osteonecrosis of the jaw to the "Precautions" and "Adverse Reactions" sections on the labeling of injectable bisphosphonates, describing the spontaneous reports of the condition being found mostly in cancer patients.

The alerts also recommend a dental examination with appropriate preventive dentistry in patients with risk factors such as cancer, chemotherapy, corticosteroids and poor oral hygiene prior to initiating treatment with bisphosphonates.

"Monitoring the dental health of patients on bisphosphonates is key, because an early diagnosis may reduce the complications resulting from advanced destruction of the jaw bone," said Dr. Ruggiero. "Since our paper was published and dentists became aware of the connection, many more patients with the condition have been identified, even in our own center. Prevention and early detection are so important to preserving the jaw bone in these individuals."

Individuals should attempt to avoid tooth extractions and other major dental work while on the drugs.

Osteoclasts Inhibit Bone Regeneration

Bisphosphonates block the work of bone cells called "osteoclasts," one of two important types of bone cells that are involved in the continuous process of bone remodeling in a delicate balancing act. During this process, osteoblasts "the good guys" put calcium in the matrix of the bone and make bone stronger. Osteoclasts "the bad guys" take calcium away, diminishing the internal strength of the bone.

Bone remodeling is like a necessary game of tug-of-war between the goods guys and the bad. Bone mass and mineral content constantly adjust throughout the life cycle to support the places on the skeleton where the most outside force occurs.

Novartiss Aredia (pamidronate disodium) and Zometa (zoledronic acid) injections are the two intravenous bisphophosphonates used in chemotherapy regimens. Novartis changed their labeling in August.

Mercks Fosamax (alendronate) and Procter and Gamble Pharmaceuticalss Actonel (risedronate sodium) are the most commonly used oral bisphosphonates, which are only indicated for osteoporosis. Labeling for the oral forms has not been changed.

"The oral form is much less potent than the intravenous form and appears to be substantially less likely to cause the problem," said Dr. Ruggiero.]]> Fosamax Side Effects Lawyer Injury Attorney Lawsuit Victims http://www.yourlawyer.com/topics/overview/fosamax Fri, 04 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/fosamax DOWNLOAD INFO PACKAGE

Fosamax Linked to Severe Musculoskeletal Pain and Osteonecrosis of the Jaw Injury - Free Lawsuit Case Review by a Fosamax Side Effects Injury Lawyer

Keywords: Fosamax | Side Effects | Lawyer | Injury | Lawsuit | Victims | Pain | Attorney | ONJ

Fosamax, a popular osteoporosis drug, has been linked to severe musculoskeletal pain (pain of the joints, muscles, and/or bones), as well as a serious bone disease called Osteonecrosis of the Jaw (ONJ), also known as "dead jaw" and "fossy jaw".  An article on the association between Fosamax and ONJ was first  published in the Journal of Oral and Maxillofacial Surgeons, which prompted the US Food and Drug Administration (FDA) to review the safety of Fosamax and other drugs in its class (bisphosphonate drugs). On January 31, 2005, Merck, the manufacturer of Fosamax, received a request for data from the FDA to update the label for Fosamax to include labeling for the jawbone tissue disease. The revised label was not made available until July 2005.

On January 7, 2008, the FDA  warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain.  The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur.

If you have used Fosamax and have suffered any sever muscle, joint or bone pain, or have experienced jaw injury or disease, contact Parker & Waichman, LLP to have a Fosamax lawyer review your case. Please complete the contact form on the right of this page to have your Fosamax side effects case review today. Alternatively, call 1-800-LAW-INFO (1-800-529-4636) to speak to someone immediately.

About Fosamax
Fosamax (Generic: Alendronate Sodium), manufactured by Merck, gained FDA approval in 1995.  Fosamax Plus D (Generic: Alendronate Sodium Cholecalciferol) contains Vitamin D.  Fosamax is prescribed to treat osteoporosis and Paget's disease. Fosamax is a type of drug known as a bisphosphonate.  Individuals using Fosamax or other bisphosphonate medications should attempt to steer clear of tooth extractions and other major dental work while on the drugs.

Fosamax is a Bisphosphonate
Bisphosphonate drugs are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonate drugs are used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously in higher doses and usually for longer periods of time.

About Osteonecrosis of the Jaw (ONJ)
Osteonecrosis of the Jaw (ONJ) is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Experts say that prevention and early treatment of patients using bisphosphonates such as Fosamax is extremely important in preserving the jawbone. Signs and symptoms of ONJ may include:  jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.  Loss of blood supply to the jaw preceeds the development of ONJ.  Fosamax reduces the activity of the cells that cause bone loss, which is supposed to decrease the rapid rate of bone loss in women after menopause.  However, this exact mechanism may be what causes osteonecrosis of the jawbone.

Fosamax and Severe Musculoskeletal Pain
According to the 2008 FDA Fosamax health alert, the severe musculoskeletal pain associated with Fosamax can occur within days, months, or years after starting treatment with the drug.  While some patients have experienced complete relief of symptoms after discontinuing Fosamax, others have reported that the pain continued.  The risk factors for and incidence of severe musculoskeletal pain associated with Fosamax are unknown. 

Although severe musculoskeletal pain was already included in the prescribing information for Fosamax, the FDA said that the association between Fosamax and severe musculoskeletal pain could be overlooked by healthcare professionals, resulting in delayed   diagnosis, prolonged pain and impairment, and the need for treatment with analgesics. The FDA has recommended that healthcare professionals be aware that the use of Fosamax could be responsible for severe musculoskeletal pain in patients who present with this symptom.   If patients on Fosamax do experience this severe musculoskeletal pain, the FDA advised that  their doctors  consider temporary or permanent discontinuation of the drug.

Free Fosamax Lawsuit Consultation
If you or a loved one took Fosamax and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call 1-800-LAW-INFO (1-800-529-4636).]]>