Yourlawyer.com (Zometa News) http://www.yourlawyer.com/topics/overview/zometa Sat, 21 Nov 2009 02:51:46 -0800 pixel-app en 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.

]]> 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.
]]> 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."]]> Zometa (zoledronic acid) & Aredia (pamidronate disodium) Associated with Osteonecrosis of Jaw http://www.yourlawyer.com/articles/read/9830 Wed, 18 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9830
The prescribing information recommends that cancer patients receive a dental examination prior to initiating therapy with intravenous bisphosphonates (Aredia and Zometa), and avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition.

Read the Novartis Dear Healthcare Professional letter below. The and revised labels for Zometa and Aredia are attached.

Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, NJ 07936

IMPORTANT DRUG PRECAUTION FOR DENTAL HEALTH PROFESSIONALS WITH PATIENTS BEING TREATED FOR CANCER

May 05, 2005

Dear Doctor:

We are writing to inform you of an adverse event Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, Aredia and Zometa, which may have an impact on the dental care of patients within your practice. While on treatment, invasive dental procedures should be avoided, if possible.

The prescribing information recommends that cancer patients:

receive a dental examination prior to initiating therapy with intravenous bisphosphonates (Aredia and Zometa); and

avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. Clinical judgment by the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

Aredia is used in the treatment of hypercalcemia of malignancy, Pagets disease, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma. Zometa is used in the treatment of hypercalcemia of malignancy, the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.

In the U.S. Package Insert for both Aredia and Zometa, the following information on osteonecrosis of the jaw has been added under the Precautions Section.

Precautions

Osteonecrosis of the jaw

Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis.

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

ONJ is a complex problem with multiple risk factors. Typical signs and symptoms of ONJ include, but are not limited to: pain, swelling, or infection of the gums; loosening of the teeth; poor healing of the gums; numbness or a feeling of heaviness in the jaw; drainage and exposed bone. The seriousness of ONJ ranges from patient being asymptomatic to requiring sections of the jaw to be removed.

Dentists, oral surgeons, periodontists, prosthodontists, dental hygienists, and other dental health professionals can play a vital role in identifying ONJ and other oral complications of cancer and cancer therapy.]]> 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.]]> Zometa Aredia Fosamax ONJ Side Effects Attorney http://www.yourlawyer.com/topics/overview/zometa Sun, 13 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/zometa DOWNLOAD OUR Zometa INFORMATION PACKAGE

Injured by Zometa?

Novartis and the FDA notified dental healthcare professionals of revisions to the prescribing information about the occurrence of Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, including Zometa (generic: zoledronic acid). The FDA posted a letter from Swiss-based Novartis that was sent to dentists  warning of the problem. The letter also said patients should avoid invasive dental procedures while on the drug.

Officials from the FDA said they were concerned that many dentists and patients were not aware of the potential for jaw problems. The issue was discussed at an FDA advisory panel meeting in March 2005. Novartis said it had started studies to see if a link between the jaw problems and Zometa exists. At the time, Novartis officials said they had received 875 reports of osteonecrosis of the jaw from December 2002 through February 2005. Zometa was first put on the U.S. market in 2001 and had more than $1 billion in global sales. Zometa is used in the treatment of hypocalcaemia of malignancy, the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

Osteonecrosis of the Jaw - ONJ
Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene). ONJ is a complex problem with multiple risk factors. Typical signs and symptoms of ONJ include, but are not limited to: pain, swelling, or infection of the gums; loosening of the teeth; poor healing of the gums; numbness or a feeling of heaviness in the jaw; drainage and exposed bone. The seriousness of ONJ ranges from patient being asymptomatic to requiring sections of the jaw to be removed. Dentists, oral surgeons, periodontists, prosthodontists, dental hygienists, and other dental health professionals can play a vital role in identifying ONJ and other oral complications of cancer and cancer therapy.

If you or a loved one took Zometa and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>