Study: FDA Fails to Issue Class I Recalls for Dangerous Prescription Drugs

| Jun 5, 2012 | Defective Drugs |

As Carrie Gann reports for ABC News, the U.S. Food and Drug Administration is behind the curve when it comes to official public recalls of the most serious problems with certain pharmaceutical drugs (known as Class I recalls). In fact, the FDA only issues Class I public notices half of the time it should.

That’s obviously bad news for patients who find themselves at risk from taking powerful and potentially-harmful prescription drugs.

As Gann reports, it appears as though the health care industry relies on the communications sent out by the FDA. That should be obvious. Problematic is the fact that the systems the FDA uses to communicate drug recalls may not be getting the message out to doctors who are prescribing those same drugs.

There’s a drug recall about once every month, according to a study conducted by researchers at the Brigham and Women’s Hospital. There are two systems used to communicate recalls: the Recall Alert System and MedWatch Safety Alert. “It’s very possible that these important recalls are being lost in the less important ones,” said one of the researchers, as Gann reports.

As it turned out, for the period of time covered by the study, a total of 18 Class I recalls weren’t issued; neither Recall Alert nor MedWatch communicated those most serious of recalls out, lost it appears in the hubbub of more than 1,700 total recalls.

SourceU.S. Has Drug Recall Problem, Study Says