Health and Medical News and Resources

General interest items edited by Janice Flahiff

FDA releases risk summaries for newer drugs

[From a news item at]

“U.S. health officials  have started releasing summaries of safety reviews for recently approved medicines as part of their efforts to inform doctors and consumers about potential side effects.”

“A 2007 law required the FDA (US Food and Drug Administration) to prepare a safety summary for certain prescription drugs 18 months after approval or after they have been used by 10,000 people, whichever comes later. Those summaries will now be posted on the FDA website.

On Tuesday, the agency released summaries for 24 medicines and two vaccines for hypertension, allergies, HIV and other conditions. It included details on what action the agency was taking.”

These Postmarketing Drug Safety Evaluations are part of the Surveillance activities of the FDA.

July 6, 2010 - Posted by | Health News Items | ,

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