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Better Ways Needed to Track Drug Safety: Report
Date:5/1/2012

TUESDAY, May 1 (HealthDay News) -- A management plan to gather, assess and respond to data about all medications' risks from the time they are approved until they are no longer on the market is needed to improve drug safety in the United States, says an Institute of Medicine report released Tuesday.

The U.S. Food and Drug Administration approves new drugs based on clinical trial evidence that their benefits outweigh their risks. However, the full range of a medication's effects may not become apparent until it is used by a larger, more diverse population over a long period of time, the FDA-sponsored report noted.

A number of drugs approved by the FDA were later found to have problems, including the pain reliever Vioxx, the diabetes drug Avandia and the cholesterol-lowering drug Crestor.

Report recommendations include:

  • The risk- and benefit-assessment and management plan for each drug should be a publicly available document that would gather data about the drug during its entire time on the market.
  • The document should describe known safety concerns at the time of the drug's approval or that become evident as it is used by consumers.
  • The document should also include all FDA regulatory actions taken on a drug, such as restrictions on its use or ordering a manufacturer to conduct further research after approval (postmarket research).

"It is not possible to know what the full range of a drug's benefits and risks will be until it is used by many different kinds of patients over time, so it is critical that FDA continues to monitor and learn about the effects of drugs after they are marketed," said report committee co-chair Ruth Faden, a professor of biomedical ethics and executive director of the Berman Institute of Bioethics, Johns Hopkins University, said in an Institute of Medicine news release.

The FDA already gathers much of this information but it is scattered across multip
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