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After the approval process

July 03, 2006|Shari Roan

The first trial in California over safety issues linked to the arthritis drug Vioxx began last week in Los Angeles County Superior Court. Meanwhile, reports are surfacing that the osteoporosis drug Fosamax, approved by the Food and Drug Administration in 1995, may cause rare cases of bone death in the jaw. Why do safety problems sometimes arise after a drug has been approved? And what can consumers do if they think they've been harmed?

-- Shari Roan


It's common for serious, rare problems linked to drugs to show up only after the medication has been approved and is widely in use. According to an article in the May edition of the Journal of the American Medical Assn., most drugs are tested in only 500 to 3,000 patients before going to market. Common adverse reactions, such as those occurring in 1 in 100 people, will show up in such studies. But more rare problems, such as those occurring at rates of 1 in 1,000, may not be detected until after a drug is in widespread use.

In fact, 51% of drugs require label changes later because of safety issues discovered after marketing, according to the article by Dr. Brian L. Strom, a professor of public health and preventive medicine at the University of Pennsylvania School of Medicine and the author of the JAMA report. Twenty percent of medications get new black box warnings (which notify users of a particularly dangerous risk) after marketing, while 3% to 4% of drugs are eventually taken off the market for safety reasons.

Examining a drug's safety record after approval -- which is called post-marketing surveillance -- relies greatly on consumers and doctors reporting adverse effects. But most cases are thought to go unreported, says Diane C. Pinakiewicz, president of the National Patient Safety Foundation, a nonprofit consumer education organization based in Massachusetts.

"If people don't report adverse events there is no way of monitoring what is happening with a drug once it goes out onto the market," she says. "People assume that once a drug is approved, it's safe."

To file a report online or to download a form, go to The FDA encourages consumers to take the form to doctors involved in their care because doctors can often provide clinical information that will help the FDA evaluate the event. However, a doctor's input is not required.

If you don't have computer access, call the FDA's toll-free information line at (888) 463-6332.

The FDA will send an acknowledgment, but don't expect anything else from the agency. FDA personnel will contact you only if they need additional information. The report may be used, however, to help the agency make future decisions about a drug's safety.

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