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FDA Fails to Publicize Serious Class I Drug Recalls

South Carolina Defective Drug Attorney

According to a new study released Monday, over an 8-year span the FDA has failed to send out important recall notifications for 1 in every 5 of the most serious drug recalls through the two electronic systems it utilizes to alert doctors and the public of the risk associated with a defective drug.

Class I recalls, (the most serious kind), are supposed to be issued for defective drugs that, if taken, have the potential to cause “serious adverse health consequences or death.”

An efficient recall system would notify doctors and patients of all Class I recalls, but wouldn’t necessarily be required to publicize less serious Class II and Class III recalls.

According to ABC News, Joshua Gagne and his colleagues from Brigham and Women’s Hospital in Boston discovered that between 2004 and 2011 more than 1,700 drug recalls were listed in the FDA’s enforcement reports. Of those, 91 were serious Class I recalls.

Although the FDA issued about 2,900 recall alerts during that time, only 51 of them were for serious Class I recalls, leaving 36 recalls to go virtually unnoticed.

MedWatch, another system used by the FDA to report drug recall information, sent alerts for 18 of the remaining recalls. Despite these efforts, doctors were still left relatively uninformed about potentially dangerous drugs, which threatened patients’ safety.

A spokesperson for Reuters health responded by saying there is more than one way the FDA communicates with doctors about drug recalls but wasn’t able to give a reason for those Class I cases that were never relayed.

Although there’s no way to know if the lack of communication was the direct cause of any patient harm, the FDA is taking steps to close the communication gaps.

Researchers are calling for a more specific alert that would be specific for Class I recalls to make sure the mistakes don’t happen in the future.

The FDA’s automatic email notices about recalls are available at or on Twitter: @FDArecalls.


If you or a loved one has been injured after taking a defective drug or receiving a defective medical device or implant, our Defective Product Attorneys offer a free consultation.  803.252.4800.










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