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:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm
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. In addition, he said, clinical trials exclude patients who might take the drug for an unapproved use or at the same time as other drugs, both factors that could affect safety and effectiveness. Rare but serious side effects might not crop up until after a drug is approved and taken by many thousands of patients, often for longer than trials lasted, he said.”
From The Associated Press:
The agency plans to publish the summaries on a quarterly basis. Each new drug, including drugs approved back to September 2007, will receive a safety summary within roughly two years of approval, according to the FDA.
"These summaries will provide clear and useful information in a timely manner that can be used by providers and patients to make informed decisions," said Dr. Robert Ball, a director in FDA's center for biologics evaluation.
Congress wrote the law in response to the 2004 scandal involving the popular
painkiller Vioxx, which was pulled from the market five years after its approval because of links to heart attack and stroke. Critics said lives could have been saved if the agency had alerted the public earlier to the safety questions surrounding the drug.
The Washington Post story:
http://www.washingtonpost.com/wp-dyn/content/article/2010/06/16/AR2010061605931.html
The USA Today story:
http://www.usatoday.com/news/health/2010-06-16-drugsafety16_ST_N.htm
The Associated Press story:
http://abcnews.go.com/Business/wireStory?id=10922037