FDA begins posting list of drugs with potential safety issues on its web site
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A list of prescription drugs currently under investigation by the FDA for safety issues is now available online.
The U.S. Food and Drug Administration began posting the list on its web site in September. The new policy is required as a result of a drug safety bill passed by Congress last year. Drugs included on the list are under investigation because of complaints reported to the FDA by drug companies, doctors and patients.
The FDA collects reports of possible side effects through its Adverse Event Reporting System. Only drugs submitted through this system will be included on the list. According to a story in the Washington Post, last year the FDA received more than 480,000 reports of potential reactions to drugs.
The FDA will update the list every three months. The first list included 20 medications and the potential problems associated with each. But, just because a drug is included on the list does not mean the drug is not safe, only that the FDA is investigating it.
According to a report on National Public Radio, FDA officials said they are trying to walk a fine line between being more open with the public and avoiding needless scares.
Some consumer groups worry that patients will stop taking necessary medication if they see it listed on the FDA web site.
The FDA’s Dr. Janet Woodcock told NPR, “My message to patients is this: Don’t stop taking your medicine. You should continue taking it unless your doctor advises you differently.”
The FDA hopes that by posting the list of drugs under investigation, they will be able to improve communication with the public and with doctors. They hope this will lead to overall improvement in drug side-effect reporting and verification.
Consumer advocates told NPR the list is a good start, but should include more information to be truly effective.
Also, it is not clear at this time how the FDA will inform the public if a drug originally included on the list is cleared of suspected safety risks.
The
list is available on the FDA web site.