FDA Announces New Site To Reveal Drug Safety Risks To Public
The FDA is planning to make safety and side effect information for new drugs easily accessible to the public and doctors amid rising concerns that serious drug safety problems only seem to arise after millions of consumers have already used the medications.
According to an FDA announcement on Tuesday, the agency will launch a new website with summaries of FDA safety reviews involving recently approved drugs. The site will also have brief discussions on what the FDA is doing to address potential issues with those drugs.
The agency says that along with the website, it will begin preparing safety summaries of new drugs within 18 months of approval, or after they have been used by 10,000 patients, whichever comes first. The more rapid post marketing analysis is part of the requirements of a 2007 law that amended the FDA’s rules to give the agency more power over medication regulation.
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The drug summaries will go back to September 2007, the FDA stated, and will be located on the Postmarketing Drug Safety Evaluation page, which was established in 2008 to relay drug safety information to the public.
The changes come after the FDA has been criticized for its handling of Merck’s painkiller Vioxx and GlaxoSmithKline’s diabetes drug Avandia.
Vioxx (rofecoxib) was a prescription drug used for treatment of chronic pain from arthritis and other conditions which cause acute pain. Before it was recalled on September 30, 2004 over concerns that it increases the risk of heart attacks and strokes, over 80 million people worldwide took the drug.
Avandia (rosiglitazone) is a diabetes drug first approved in the U.S. in 1998. The drug has come under intense scrutiny by lawmakers and critics who say that Avandia side effects may have killed or injured 100,000 people.
A recent Senate report determined that GlaxoSmithKline bullied the scientific community to keep quiet concerns about Avandia health risks, and revealed that drug reviewers inside the FDA had been calling for an Avandia recall for several years, saying that the risks of the drug outweighed the benefits.
According to the changes announced by FDA, the drug reviewers’ concerns in situations like the Avandia case would be made available to the public on the new website.
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