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Generic Drug Recall Raises More Questions


Last week's surprise announcement by the U.S. Food and Drug Administration that a popular generic antidepressant is not equivalent to the original drug also raises concerns doctors and patients have had about other generic versions of common medications.

In an about-face, the FDA announced it had notified drug company Teva Pharmaceuticals to stop shipping Budeprion XL 300 milligrams, a copycat of the extended-release antidepressant Wellbutrin XL 300 milligrams, and to remove it from U.S. shelves.

The highly unusual decision contradicts the agency's 2008 finding in which it emphatically declared that the two drugs were interchangeable, despite hundreds of patients who had complained that the generic did not work as well or caused side effects such as headaches, anxiety and insomnia, National Public Radio reported.

The reversal also echoes ongoing concerns about generics from pharmacists and doctors. In particular, they are concerned that blood thinners, seizure medications and drugs for irregular heartbeat may need stricter government scrutiny to ensure that generic formulations work in the same way as the drugs they mimic.

The debate over the antidepressant Budeprion XL, prescribed for anxiety, depression and nicotine withdrawal, had been going on for five years. In 2007 the independent drug-testing company published an analysis of the two antidepressants, indicating Budeprion XL 300 milligrams released 34 percent of its active ingredient in just two hours, compared with 8 percent for Wellbutrin XL 300 milligrams, NPR reported.

The FDA now says its initial lab tests of Budeprion had been done on the 150-milligram version, under the assumption those results would also apply to the 300-milligram version. When the FDA finally tested the 300-milligram pills this past summer, it notified Teva to stop shipment of the generic.

Patients with a prescription for Budeprion XL 300 milligrams should contact their doctors for advice on how to proceed, the FDA said. The FDA action does not affect Budeprion 150 milligrams.

The problems with the generic antidepressant reflect other worries about generics, according to the Los Angeles Times, which has been following the issue.

The American Epilepsy Society has called on the FDA to test whether generic antiseizure drugs work as well as the originals, and cardiologists have had long-standing worries about the effect of switching patients whose blood has been thinned with Coumadin to generic versions of the anticoagulant, including warfarin.

Many cardiologists have warned that patients with heart arrhythmias should be switched to generic drugs only when necessary. They also have voiced concerns over the growing number of generic blood pressure and cholesterol drugs, the Times reported.

There's no question that generic drugs are a bargain. But if you've been switched to a generic, you need to be aware of side effects or changes in your condition that might result from using a different formulation.

From the Los Angeles Times, here are some tips to follow:

  • When you're given a new prescription, check to see whether you've been switched to a generic or from a generic made by one manufacturer to one made by a different generic-drug maker.
  • If you have, pay attention to new side effects, a return of symptoms or any change in your condition.
  • If you notice something new, talk to your physician and suggest that he or she make a report to the FDA's Medwatch system, which tracks drug-related "adverse events."

In other health news:

Your pet can catch the flu from you.   Humans aren't the only ones at risk for contracting the flu this season: our furry friends can fall ill from the disease as well, reports In fact, flu infections in cats and dogs may be much more common than thought, experts say. And pets can catch the flu from their owners, research finds.

Photo: via flickr

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