Risks of some acid-reducing drugs may outweigh benefits

More than 113 million prescriptions are written every year for proton pump inhibitors, drugs such as Prilosec or Nexium that Americans take to treat ulcers or other problems affecting the stomach or esophagus. But more than half the time these acid-reducing drugs are overprescribed for less serious heartburn or indigestion, according to research cited in tomorrow's Archives of Internal Medicine.

The drugs do relieve stomach discomfort, but people who take them may be more likely to encounter other problems such as fractures or certain infections, three new studies say.

"For most patients the adverse effects of [proton pump inhibitors] outweigh the benefits," Dr. Mitchell Katz of the San Francisco Department of Public Health writes in an editorial.

Dr. JoAnn E. Manson of Brigham and Women's Hospital was part of a team that looked at the acid-suppressing drugs and broken bones related to osteoporosis among more than 161,000 older women enrolled in the the Women's Health Initiative. After eight years, women who took the drugs were no more likely to break their hips than women who didn't take the drugs. But they did have a 47 percent increased risk of spine fractures, a 26 percent increased risk of forearm or wrist fractures, and a 25 percent increased risk of other fractures. The authors advise doctors to periodically evaluate whether their patients should continue to take the drugs.

Two other studies consider whether proton pump inhibitors are linked to infections with Clostridium difficile, the leading cause of hospital-acquired diarrhea. Dr. Michael D. Howell of Beth Israel Deaconess Medical Center led a study that analyzed more than 100,000 admissions to the hospital. Patients who took proton pump inhibitors daily were 74 percent more likely than other patients to develop a C. difficile infection in the hospital, with the risk climbing higher with greater use of the drug.

In the other study, Dr. Amy Linsky of Boston Medical Center and her colleagues report on patients whose C. difficile infections recurred within 90 days. Among more than 1,100 patients treated at the New England Veterans Healthcare System, those who used proton pump inhibitors had a 42 percent higher risk of recurrence than patients who did not take the drugs.

Katz, who wrote the editorial, says doctors may want to ask their patient to try other ways to treat indigestion, such as eating smaller meals, losing weight, quitting smoking, reducing stress, or raising the heads of their beds at night. Or none of those. "Many cases ... resolve on their own," he writes.

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Mylan Receives FDA Approval for Generic Version of Prevacid

Mylan Inc. today announced that its privately held Indian subsidiary, Matrix Laboratories Limited, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand.

Lansoprazole DR Capsules are the generic version of Tap Pharmaceuticals’ proton pump inhibitor Prevacidآ® DR Capsules. The brand product had U.S. sales of approximately $3 billion for the 12 months ending June 30, according to IMS Health.

Currently, Mylan has 125 ANDAs pending FDA approval representing $84.1 billion in annual brand sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.2 billion in annual brand sales, for the 12 months ending June 30, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates the world’s third largest active pharmaceutical ingredient manufacturer; and runs a specialty business focused on respiratory and allergy therapies.

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New warning on mixing clopidogrel , stomach drugs

Heart attack patients taking the blood thinner clopidogrel (Plavix) received a strong warning today about also taking a stomach-soothing proton pump inhibitor drug, such as Nexium, Prevacid, or Prilosec, at the same time. This drug combination is routinely prescribed to patients after a heart attack to decrease the risk of stomach irritation and bleeding, but a new study suggests the stomach drugs can interfere with how Plavix works and may actually raise the risk of having another heart attack.

Plavix helps reduce the risk of blood clots that can lead to another heart attack. However, it can also be hard on the stomach and cause gastrointestinal bleeding, so patients are often prescribed proton pump inhibitors (PPIs) to help prevent this. But previous studies have suggested the PPIs reduce Plavix's protective effect. The new study, which appears in the March 4 issue of the Journal of the American Medical Association, adds to the body of evidence that shows patients taking these drugs together face an increased risk of heart attack and death.

In the study, researchers examined the records of 8,205 patients taking Plavix after suffering a heart attack or angina. More than 5,200 patients were also taking a PPI. Nearly 30% of the PPI group died or were rehospitalized for heart attack or angina, compared with 21% of the patients who did not take a PPI. Overall, patients taking a PPI had about a 25% increased risk of death or being rehospitalized.

In January a Canadian study found that patients taking Plavix and a PPI had a 40% increased risk of having a second heart attack than patients taking only Plavix. At the time, the FDA said the evidence was insufficient to pin the blame on PPIs because some studies suggested the drugs did not interfere with Plavix. The agency is currently working with the makers of Plavix, Sanofi-Aventis and Bristol-Myers Squibb, to better understand how PPIs interact with Plavix. It could take several months before those studies are finished.

In the meantime, here's what our medical consultants recommend: The overall incidence of gastrointestinal bleeding with Plavix is actually quite low. Only about 2% of patients will experience this side effect (the risk will be higher if you are also taking aspirin). To help prevent bleeding while taking Plavix, instead of taking a PPI, a better option is an older class of drugs called H2blockers, which includes nizatidine (Axid), famotidine (Pepcid), and ranitidine (Zantac). You could also try an antacid. These drugs have not been associated with dampening the protective effects of Plavix. You should also talk to your doctor about having periodic blood counts or monitoring of your stools in order to detect gastrointestinal bleeding you may not be aware of (black, tarry stools can be a sign of this, for example).

Source : blogs.consumerreports.org

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