Yourlawyer.com (Proton Pump Inhibitors News) http://www.yourlawyer.com/topics/overview/Proton_pump_inhibitors Sat, 21 Nov 2009 23:35:00 -0800 pixel-app en Plavix Users Warned Not to Take Prilosec, Nexium http://www.yourlawyer.com/articles/read/17291 Wed, 18 Nov 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/17291 Prilosec and Nexium reduce the anti-clotting effects of Plavix, according to a Public Health Advisory issued by the U.S. Food & Drug Administration (FDA).  As a result, patients at risk for heart attacks or strokes who use Plavix to prevent blood clots will not get the full effect of this medicine if they are also taking Prilosec or Nexium. The agency warned yesterday that patients who take Plavix should use different medications to treat acid reflux, such as Mylanta or Zantac.

Prilosec  inhibits the drug metabolizing enzyme (CYP2C19) which is responsible for the conversion of Plavix into its active form (active metabolite), the FDA said.  New studies compared the amount of   Plavix's active metabolite in the blood and its effect on platelets (anti-clotting effect) in people who took Plavix and Prilosec versus those who took Plavix alone. A reduction in active metabolite levels of about 45 percent was found in people who received Plavix with Prilosec compared to those taking Plavix alone. The effect of Plavix on platelets was reduced by as much as  47 percent in people receiving Plavix and Prilosec together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the agency said.

Prilosec is one of a class of drugs known as Proton Pump Inhibitors (PPIs). PPIs are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. According to the FDA, the level of inhibition among other PPIs varies, so it is unknown to what extent other PPIs may interfere with Plavix. However, Nexium, a PPI that is a component of  Prilosec, also inhibits CYP2C19 and should also be avoided in combination with Plavix.

The FDA also advised that other drugs that are potent inhibitors of the CYP 2C19 enzyme would be expected to have a similar effect and should be avoided in combination with Plavix. These include: Tagamet, Diflucan, ketoconazole (sold as Nizoral, Extina, Xolegel, Kuric), VFend, etravirine (known as Intelence or TMC125), Felbatol, Prozac, Luvox, and Ticlid.

The manufacturers of Plavix have agreed to look at other possible drug interactions with Plavix. In the meantime, the Plavix label will be updated with new warnings on Prilosec and other drugs that could interact with Plavix in the same way. When more information becomes available, the FDA will communicate any additional recommendations or conclusions on the use of Plavix.

Finally, the FDA advised patients taking Plavix to consult their healthcare provider if they are currently taking or considering taking Prilosec, Prilosec OTC or Nexium. It is also very important that patients talk with their healthcare professional about any over-the-counter drugs they are taking before starting or while using Plavix.  Patients should always consult with their healthcare professional before starting or stopping any medication.

]]> Long-Term Use of PPIs May Lead to Dependency http://www.yourlawyer.com/articles/read/16717 Tue, 07 Jul 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16717 Proton Pump Inhibitors (PPIs) could lead to dependency if taken at prescription strength over an extended period of time, new research suggests.  According to a report on Medicinenet.com, researchers at Copenhagen University have found that healthy adults without symptoms of acid reflux who took PPIs developed symptoms of the disorder when they stopped taking them after 8 weeks.

The study, which was published in the journal Gastroenterology, involved 120 healthy adults.  According to Medicinenet.com, half of the subjects took 40 milligram doses of Nexium for 8 weeks, and a placebo for the final four weeks of the trial.  The other half took a placebo for the entire 12 weeks.

At the beginning of the trial, participants in both groups reported similar gastrointestinal  symptoms.  But in weeks 9 through 12, 44% of those who had been taking Nexium reported increased symptoms, while in the placebo-only group, only 15% reported increased symptoms. By the end of the 12 week trial, despite being off Nexium for four weeks, 22% of those in that group still reported symptoms, while less than 2% in the placebo only group were reporting similar symptoms.

According to the researchers, all study participants did report that symptoms had stopped three months after Nexium treatment had ended.

According to Medicinenet.com, the researchers theorized that this "rebound"  effect was likely a response to the acid suppression caused by Nexium that  resulted in an overproduction of the stomach acid-stimulating hormone gastrin.    The effect  likely lasts between four weeks and three months, they said.  

Despite this effect, the researchers said that the benefits of PPIs outweigh the risks for those who need them.  However, according to Medicinenet.com, they expressed concern that the drugs are being overprescribed, and said doctors need to be more selective about how PPIs are prescribed.

PPIs are taken by millions of people - according to Medicinenet.com, it is estimated that 5% of adults in developed countries take the acid-reducing drugs.   But PPIs have been the subject of safety concerns.  As we've reported previously, a recent Canadian study of PPIs and osteoporosis-related fractures revealed a link between long-term PPI use and increased risk for hip, wrist, or spine fractures. We also reported in May  that Plavix  users were warned by the Society for Cardiovascular Angiography and Interventions (SCAI) to avoid PPIs following stent implantation because the combination increases the risks for heart attack (by 70 percent), stroke (48 percent), and other cardiovascular problems (repeat heart procedures by 35 percent).  And most recently, we reported on a Canadian study that found a connection between  routine prescription of PPIs during hospitalizations and  an increased risk—30 percent—of acquiring pneumonia.

]]> Acid Reflux Drugs Linked to Increased Fracture Risk http://www.yourlawyer.com/articles/read/14931 Tue, 12 Aug 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14931 Proton Pump Inhibitors, or PPIs—that the US Food and Drug Administration (FDA) investigated for a suspected link between cardiac trouble and PPIs.  Also, because such drugs may be overly effective at stopping stomach acid production, they have been know to raise pneumonia, bone loss, and fracture risk; this, by over 40 percent in patients on long-term use.

Now, a new Canadian study of PPIs such as Aciphex, Nexium, Prevacid, Prilosec, and Protonix and osteoporosis-related fractures has revealed a link between long-term use of PPis and increased risk for such fractures of the hip, wrist, or spine.  The link appeared in patients taking PPIs after about seven years.  PPI drug makers claim they haven't seen increased osteoporosis-related fracture risk in people using their products.

The study included about 63,000 adults aged 50 and older in Manitoba, Canada, and also included about 15,300 patients who sustained an osteoporosis-related fracture of the hip, spine, or wrist from 1996 to 2004.  The researchers, including University of Manitoba's Laura Targownik, MD, MSHS, also reviewed participants' prescription records and found that those who received an osteoporosis-related fracture were nearly twice as likely to have taken a PPI for at least seven years; those on PPIs for six or less were not linked to fracture risk.  Those with hip fractures were 62% more likely to have used a PPI for at least five years.

It remains unclear how PPIs might increase fracture risk, but some experts believe it may be related to their stomach acid inhibiting qualities.  Targownik's team speculates that PPIs speed up bone mineral loss; however, the study doesn't prove this.  Also, the researchers considered a variety of other factors, including participants' other prescriptions, medical history, and income.

Meanwhile, long-term PPI use and fracture risk have been linked in previous research and that association "is certainly a strong basis for encouraging further investigation," write the editorialists, who included J. Brent Richards, MD, of Canada's McGill University.  "Certainly, at one extreme, such as in patients with bleeding ulcers, the beneficial effects may far outweigh the risks associated with fractures," the editorial states. "At the other extreme, liberal prescription of proton pump inhibitors for nebulous disorders for extended periods of time is likely worth revisiting."

Targownik's study doesn't specify which PPIs the patients took.  AstraZeneca, maker of Nexium responded, "AstraZeneca does not agree with the conclusion of the CMAJ study," said spokeswoman Corey Windett   Judee Shuler, senior director of corporate communications for Eisai Inc., maker of Aciphex, said the results "warrant further study, as these fractures are important medical issues that can occur for a variety of reasons.

According to an editorial published along with the study and that appeared in the Canadian Medical Association's journal, CMAJ , additional research is needed.  Until then, they suggest patients and their doctors reevaluate the risks and benefits of long-term PPI use.

]]> Protonix Investigation Yields Subpoenas http://www.yourlawyer.com/articles/read/14887 Tue, 05 Aug 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14887 Protonix medication has issued the drug maker several subpoenas. The grand jury is probing Wyeth's marketing and pricing of the heartburn drug.  

The Massachusetts Protonix inquiry has been going on since 2005.  According to a regulatory filing recently released by Wyeth, Current and former employees have testified before the grand jury this year. The subpoenas sought ``information and testimony'' about how Wyeth promoted and priced Protonix pills and intravenous products, according to the filing.

Protonix is one of a class of drugs called proton pump inhibitors. Proton pump inhibitors are used to achieve pronounced and long-lasting reduction of gastric acid production.  These drugs are meant to be used in people who suffer from gastric reflux disease and other stomach ailments. Proton pump inhibitors are among the most widely-prescribed drugs in the U.S.  Some patient advocates believe proton pump inhibitors are prescribed too frequently, and not enough attention is paid to their side effects.

One of those side effects may include hip fractures.  In 2006, the Journal of the American Medical Association (JAMA) published a study that indicated that Protonix and other proton pump inhibitors could increase the rip of hip fractures by as much as 260 percent.  

Researchers conducting the proton pump inhibitors collected statistics on 13,556 people with hip fractures and 135,386 healthy people, all aged 50 or older. The researchers discovered that taking a proton pump inhibitor for more than one year increased the threat of hip fracture by 44%, compared with people not taking these medications. Additionally, the risk was 2.6 times higher among people who took high doses over a long period. The risk of hip fracture increased with both the dosage and the duration of proton pump inhibitor therapy.

]]> Heartburn Drugs = Broken Bones? http://www.yourlawyer.com/articles/read/12433 Fri, 29 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12433 Tess Calbach goes to the Eau Claire Senior Citizen Center everyday and says she’s glad to have a place to “hang out.”
Several years back she had work done on her left hip.

She says her hip is doing fine now but she's taking medications for her stomach--Prilosec to be specific--a prescribed antacid.

She's been taking a pill a day with dinner for the past six years.

We asked her if she thought her bone replacements were because of the Prilosec. She says she doesn’t believe it had anything to do with it.

A study of nearly 14,000 hip fracture cases in Britain reports elderly people like Tess who take drugs like Prilosec, Prevacid, or Nexium may make it difficult for the body to absorb calcium.

That could lead to greater risks of getting broken hips.

“The longer you are taking this medication they found out that they risk of fractures actually goes up almost exponentially,” said Gastroenterology Dr. Olufemi Abiodun at Marshfield Clinic.

To be precise, the researchers report a 44 percent increased risk of breaking a hip during a fall.

But Dr. James O'Conner at Luther Midelfort doesn't agree it's that high.

“I think the direction is real there's probably a higher risk in that subgroup because the medications they reduce acidity.
Not all antacids are bad, O'Conner recommends Tums.

Tums have a calcium source so he even recommends taking five a day because people don't get enough of it in their diet.
Others like Zantac and Malox though are something different.

“The other drugs reduce the acidity in
the stomach and by reducing that, it reduces the ability for your body to metabolize and absorb calcium,” said O’Connor.
Doctors say more evidence is needed to prove the connections.

In the mean time, Tess says she's going to keep taking her meds.

“As long as I'm taking my vitamins and eat regularly I think my stomach can take care of it.]]> Antacids Like Prevacid, Nexium, and Protonix May Lead to Hip Fractures in Seniors http://www.yourlawyer.com/articles/read/12422 Wed, 27 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12422
In the JAMA report, researchers led by the University of Pennsylvania’s Dr. Yu-Xiao Yang noted, “We found a significantly increased risk of hip fracture associated with long-term PPI therapy, particularly among long-term users of high-dose PPI…. Calcium malabsorption secondary to acid suppressive therapy may potentially explain the positive association. Calcium solubility has been believed to be important for its absorption. An acidic environment in the gastrointestinal tract facilitates the release of ionized calcium from insoluble calcium salts.” The team also said that “the increase in fracture risk surged from a modest level with regular-dose PPI therapy to a much higher magnitude with high-dose PPI therapy.”

The study used the United Kingdom’s General Practice Research Database (1987-2003) to examine the medical records of nearly 150,000 British patients and included 13,556 hip fracture cases and 135,386 controls. The study cohort consisted of users of PPI therapy and nonusers of acid suppression drugs who were older than 50 years. The risk of hip fracture associated with more than one year of PPI therapy was 44 percent higher. However, among those patients prescribed long-term high-dose PPIs, the risk of hip fracture was significantly more than double. The longer the duration of PPI therapy, the stronger the association between PPIs and hip fractures.

A hip fracture in seniors can have potentially devastating consequences. The mortality rate during the first year after a hip fracture is approximately 20 percent. Another 20 percent will require nursing home care. Therefore, any reduction in the incidence of hip fractures would have far-ranging financial and medical implications. The authors are urging medical professionals to be more diligent when recommending PPI therapy, even with over-the-counter medications, and to make sure they’ve explained the potential risks to patients.
]]> Study links heartburn drugs, broken hip http://www.yourlawyer.com/articles/read/12423 Wed, 27 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12423
The study raises questions about the safety of some of the most widely used and heavily promoted prescription drugs on the market, taken by millions of people.

The researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. That can lead to weaker bones and fractures.

Hip fractures in the elderly often lead to life-threatening complications. As a result, doctors should make sure patients have good reason to stay on heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine.

"The general perception is they are relatively harmless," Yang said. "They often are used without a clear or justified indication for the treatment."

Some people find relief from heartburn with over-the-counter antacids such as Tums, Rolaids and Maalox. But for others, those medicines do not work well. Moreover, heartburn can be more than a source of discomfort. People with chronic heartburn can develop painful ulcers in the esophagus, and in rare cases, some can end up with damage that can lead to esophageal cancer.

Dr. Sandra Dial of McGill University in Montreal, who was not involved in the study but has done similar research, said patients should discuss the risks and benefits with their doctors and taper off their use of these medicines if they can.

Nexium, Prevacid and Prilosec are members of a class of drugs known as proton pump inhibitors. The study found a similar but smaller risk of hip fractures for another class of acid-fighting drugs called H2 blockers. Those drugs include Tagamet and Pepcid.

The study, published in Wednesday's Journal of the American Medical Association, looked at medical records of more than 145,000 patients in England, where a large electronic database of records is available for research. The average age of the patients was 77.

The patients who used proton pump inhibitors for more than a year had a 44 percent higher risk of hip fracture than nonusers. The longer the patients took the drugs, the higher their risk.

The biggest risk was seen in people who took high doses of the drugs for more than a year. That group had a 2 1/2 times greater risk of hip fractures than nonusers.

Yang said that for every 1,262 elderly patients treated with the drugs for more than a year, there would be one additional hip fracture a year attributable to the drugs. For every 336 elderly patients treated for more than a year with high doses, there would be one extra hip fracture a year attributable to the drugs.

Dr. Doug Levine of AstraZeneca PLC, which makes Nexium and Prilosec, said the study does not prove that proton pump inhibitors cause hip fractures. It merely suggests a potential association, he said. Doctors need to monitor their patients for proper dosage and watch how long they take the drugs, Levine said.

Julia Ellwanger, a spokeswoman for TAP Pharmaceutical Products Inc., which markets Prevacid, said proton pump inhibitors' safety has been well-established by rigorous studies, and the new study does not prove or disprove a connection to hip fractures.

Dr. Alan Buchman of Northwestern University, who was not involved in the research, said the study should not change medical practice, since doctors already should be monitoring the bone density of elderly people taking the drugs and recommending calcium-rich diets to all patients.

"Most people are not taking enough calcium to start with," he said. He also wondered if a similar result would have been found in a sunny climate, because vitamin D from sunshine helps with calcium absorption.

Also, Buchman said it not known whether the acid-fighting drugs prevent esophageal cancer. He said the risk of esophageal cancer has been exaggerated in the marketing of these drugs.

"I think the risk has been overplayed and scared the community," Buchman said.

Heartburn medicines are heavily are advertised in "Ask your doctor about" commercials in this country, particularly during the evening news.

Nexium is the third biggest selling drug in the world, behind the cholesterol medicine Lipitor and blood thinner Plavix, with global sales totaling $5.7 billion last year, according to IMS Health, which tracks drug sales.

Yang and his co-authors disclosed in the paper that they have worked as consultants and received speaking fees from companies making acid-fighting drugs. The study was funded by the National Institutes of Health and the American Gastroenterological Association/GlaxoSmithKline Glaxo Institute for Digestive Health.

Men in the study had a higher drug-associated risk of hip fracture than women, possibly because women may be more aware of osteoporosis and may get more calcium in their diets, Yang said. He plans more research on whether calcium-rich diets or calcium supplements can prevent the problem.
]]> Popular Heartburn Drugs May Lead to a Broken Hip http://www.yourlawyer.com/articles/read/12424 Wed, 27 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12424
Research published in the new issue of the Journal of the American Medical Association found that people who took such prescription antacids for more than one year were 44 percent more likely to have a hip fracture than those who didn't take them.

"We think that calcium may be the major underlying mechanism here," says Yu-Xiao Yang, lead researcher and assistant professor of medicine and epidemiology at the University of Pennsylvania. PPIs reduce acid production in the stomach, and because acid helps absorb calcium, Yang speculates that the drugs may hinder the body's ability to absorb the bone-strengthening element.

Hip fractures are particularly devastating in older people, with an estimated mortality rate of 20 percent in the first year after a hip fracture. For those who survive, 1 in 5 needs nursing-home care, the researchers report.

Yang and colleagues analyzed people 50 and older in the General Practice Research Database from 1987 to 2003, a comprehensive pool of health data from patients in the United Kingdom. They assessed information on 13,556 hip fracture patients and 135,386 healthy patients, and they found that prescription PPI use was associated with greater odds of a hip fracture.

Longer-term use at higher doses made the problem worse. "There is a surge of risk when you go from a regular dose to a high dose," says Yang. The study found that people who used PPIs for more than a year at doses above the recommended prescription strength were nearly three times as likely to have a hip fracture as nonusers.

The research also found that male long-term users of the drug were slightly more prone to fracture their hips than female long-term users. Though use of calcium supplements wasn't measured, Yang suggests they might contribute to the gender disparity, since women over 50 commonly take calcium tablets. Yang says he has been recommending that patients on PPIs protect bone mass by boosting their calcium intake. "If you're taking PPIs, you don't want to be one of those people not getting enough calcium."

Michael Schaefer, chair of the department of orthopedic surgery at Northwestern University Feinberg School of Medicine, says the study sheds new light on the complex problem of osteoporosis, the reduction of bone mass that can lead to hip fractures. "Osteoporotic hip fractures are multifactorial," he says. While he's not convinced this new research solves the problem, he adds that "as an orthopedist, here is something I need to be aware of."

Schaefer tells his patients to quit smoking and increase physical activity–especially weight-bearing exercises–to combat and prevent osteoporosis. But he says he'll now urge patients on PPIs to take extra calcium. "I'm a big believer in calcium supplementation."]]> Proton Pump Inhibitors Fracture Risk In The Elderly http://www.yourlawyer.com/topics/overview/Proton_pump_inhibitors Wed, 27 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/Proton_pump_inhibitors Proton Pump Inhibitors Linked to Hip Fractures Proton Pump Inhibitors Linked to Hip Fractures
On December 26, 2006, a report was released that showed the correlation between people taking powerful antacid drugs called proton pump inhibitors and the increased risk of hip fractures.  The report was based on a University of Pennsylvania study that showed a class of antacid drugs called proton pump inhibitors could increase the risk of hip fractures as much as 260 percent. Proton pump inhibitors are usually prescribed for gastroesophageal reflux disease (GERD), and are.among the most widely used drugs in the United States. Popular drugs in the class include: Aciphex, Nexium, Prevacid, Prilosec and Protonix. which are often prescribed for stomach conditions such as

The University of Pennslyvania report can be found in the Dec. 27, 2006 issue of the Journal of the American Medical Association (JAMA).

"If you take acid-suppression medications on a chronic basis and you are 50 or older, your hip fracture risk is even higher than usual," said study author Dr.Yu-Xiao Yang, an assistant professor of medicine and epidemiology. "In addition, if you are one of the few patients who requires high doses, then your risk is even higher," Yang added.

Study Results
In the study, a team lead by study author Dr.Yu-Xiao Yang collected statistics on 13,556 people with hip fractures and 135,386 healthy people, all aged 50 or older. The researchers discovered that taking a proton pump inhibitor for more than one year increased the threat of hip fracture by 44%, compared with people not taking these medications. Additionally, the risk was 2.6 times higher among people who took high doses over a long period. The risk of hip fracture increased with both the dosage and the duration of proton pump inhibitor therapy, Yang's team found.

Yang said he feels these drugs are prescribed too often. "Not everybody is on this medicine for good reasons," he said. "Proton pump inhibitors have been on the market for 15 years, and the general feeling is that they are safe to be taken on a chronic basis. So, they are given often without having a clear indication or without making sure the patient is benefiting from the medication." Moreover, Yang thinks that both men and women taking prescription proton pump inhibitors should also take a calcium supplement to insure that they maintain their bone mass and lower their risk of hip fracture.

Dr. Lawrence Brandt, chief of the Division of Gastroenterology at Montefiore Medical Center, in New York City, said "Proton pump inhibitors are probably one of the most abused classes of drugs in the world. So, there are a lot of people on this medication who shouldn't be on this medication." While Acphex, Nexium Prevacid and Protonix all require a prescription, Prilosec is now sold over the counter which increases the potential for overuse.

Legal help for Proton Pump Inhibitor users
If you or a loved one suffered a fractured hip as a result of using a Proton Pump Inhibitor, contact Parker & Waichman, LLP for a free case evaluation. Call 1-800-LAW-INFO (1-800-529-4636) or fill out the short form to the right of this page.]]>