PUBLIC HEALTH
June 25, 2010

FDA Makes Problem Drugs Public

A new FDA website tracks problems people have had with various prescription drugs. Bookmark it.

The FDA has a new website that lists problems that crop up with drugs after they've hit the market.

Many side effects and problems caused by a drug don't become apparent until well after the drug is in use. The new website compiles information about these problems as they emerge. Having this information together in one spot means that doctors and consumers don't have to search all over the web for it and also means that the information should spread faster. Problems should become apparent quicker than in the past.

A 2007 law requires such information to be posted for all new drugs within 18 months of their approval or after they have been used by 10,000 patients, whichever comes later. These drug safety summaries will be released quarterly.

The information comes from complaints from consumers, doctors and companies, as well as from FDA reviewers' searches of medical literature and ongoing studies.

A 2007 law requires such information to be posted for all new drugs within 18 months of their approval or after they have been used by 10,000 patients, whichever comes later. These drug safety summaries will be released quarterly. The first summaries, covering 24 drugs and 2 vaccines, have just been released.

While the first summaries don't seem to have picked up any major problems, one recent problem has come up with the asthma drug Alvesco. There have been reports of ineffectiveness, which seem to be coming from mechanical problems that develop over time in the drug delivery system (the drug is used with an inhaler). This problem has not yet been solved and the situation remains under investigation.

The idea behind the site is to avoid another situation like the one that happened with Vioxx or worse, thalidomide, or at least to catch them a lot sooner. In 2004, the drug Vioxx was pulled from the market because of concerns that it might be causing strokes and heart attacks. In the late 1950s, the drug thalidomide was used as a tranquilizer throughout Europe, though it was never approved for use in the U.S. Thalidomide use during pregnancy caused an estimated 10,000-20,000 serious birth defects in Europe (but only about 20 in the U.S.). What's hard to understand is that these births occurred between 1956 and 1962, a six-year period. It took that long to make the connection.

These are the type of worst case scenarios the drug safety summaries should help avoid. And they should also help point out any irritating but less severe side effects caused by new drugs a lot sooner than has happened in the past.

The drug safety summaries can be found at the FDA's Postmarketing Drug Safety Evaluation website. They will be updated four times a year.

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