U.S. FDA to post risk summaries for newer drugs

U.S. health officials will post summaries of risks from recently approved medicines on a government website in an effort to keep doctors and consumers informed about potential side effects.

The information will come from post-approval reports of health problems, medical literature and ongoing studies, the Food and Drug Administration said in a statement on Tuesday.

The FDA and companies track potential problems after a drug reaches the market as some side effects do not emerge in pre-approval testing.

A 2007 law requires the FDA to prepare a safety summary for certain prescription drugs within 18 months of approval, or after they have been used by 10,000 people.

The FDA has moved to make public more information about drug risks since running into criticism for its handling of problems with medicines including Merck & Co’s pain reliever Vioxx, which was pulled from the market in 2004 after it was linked to heart attacks and strokes.

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WASHINGTON (Reuters)