Beginning this week, the Food and Drug Administration is posting results online of safety evaluations of drugs and vaccines that have been recently released.
Reviews of 26 new products were posted Tuesday. The safety evaluations are released 18 months after a new drug comes on the market or after 10,000 people have used it, whichever comes later. Previously, the information wasn’t made public, but a law passed in 2007 required the agency to make more safety information available to consumers.
Here’s a link to the page:
These are “post-market” evaluations; in other words, evaluations of the drug’s effects after it hits the mass market. While all drugs are studied and tested in clinical trials before release, sometimes different side effects are noted once a drug is released on a much wider basis.
From the Washington Post:
“Rare and sometimes serious side effects are often discovered only when a drug is used by a much larger and more varied group of patients than were exposed to it in clinical trials leading to its approval.
“The "post-market" analysis draws on many sources of information -- spontaneous reports of problems from doctors and patients, new studies, foreign experience with the drug, pharmaceutical company data and information from prescription data bases.”
From USA Today:
“The agency is making a "broad sweep" of adverse-event reports, medical studies and research, and drug utilization databases to look for safety problems, Robert Boucher, an official in the FDA's Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research, said at a news briefing.
“The agency has drawn criticism in recent years for not paying enough attention to safety once drugs are approved and enter the "real world," where they're used by much larger and more diverse groups of patients than those in pre-approval trials.
“For example, Boucher said, clinical trials often exclude the elderly, children, ethnic minorities and pregnant women.