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Most Consumers in the Dark on FDA Drug Recalls

Filed June 5th, 2012 Laurie

On average, the Food and Drug Administration recalls a drug about once a month, but according to a new study, the agency could be doing a better job of making the public aware of medication recalls. Researchers found that the FDA failed to send notifications for one in every five of the most serious recalls through its two electronic systems used to alert doctors and the public.

Class I recalls are the most serious, and are issued for drugs that have the potential to cause “serious adverse health consequences or death” if taken.

“I think a good system would indicate all of the Class I recalls, and it wouldn’t necessarily communicate recalls the FDA deems less important, such as Class II and Class III,” said Joshua Gagne, from Brigham and Women’s Hospital in Boston.

Gagne and his colleagues counted over 1,700 drug recalls between 2004 and 2011, and 91 were serious Class I recalls. During that time, however, the FDA’s notification systems only sent alerts for 55 of the 91 Class I recalls. MedWatch, another system used by the FDA to report drug recall information, sent alerts for 18 of the remaining recalls. Another 18 recalls were never reported through either system.

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