By: Jonathan Benson
Dozens, if not hundreds, of pharmaceutical drugs are recalled every single year because of contamination or adverse side effects, but many pharmacists and healthcare providers never get the memo. According to a new study published in the journal Archives of Internal Medicine, the U.S. Food and Drug Administration (FDA) fails to effectively report as many as 40 percent or more of all Class I drug recalls, which are the most serious type.
For their study, a team of researchers from Brigham and Women’s Hospital in Boston first counted all the drug recalls that occurred between 2004 and 2011 – they were able to identify 1,700 of them. Among these 1,700 were 91 that constituted Class I recalls, the most severe type for which there is potential for serious injury or death if patients continue taking the drugs in question.
Upon review, the team found that the FDA’s official Recall Alert System only issued official alerts for 55 of the 91 Class I recalls, or about 60 percent of them. The FDA’s MedWatch system, which also issues recall alerts, did send out alerts for 18 of the remaining 36 recalls, but the final 18 recalls were never even addressed by the FDA.
So between the FDA’s Recall Alert System and MedWatch, the two systems through which the agency sends out drug recall notifications, there is an overall failure rate of between 20 and 40 percent when it comes to effectively sending out critical drug recall information to healthcare providers. As a result, many doctors and pharmacists likely continued dispensing these dangerous drugs to their patients, which may have resulted in potentially thousands of needless deaths.
“Despite recent efforts by the FDA to address the drug recall burden, health care providers may be inadequately informed about clinically important recalls that threaten patient safety,” wrote the authors. “It’s very possible that these important recalls are being lost in the less important ones,” added Joshua Gagne, an epidemiologist at Brigham and Women’s Hospital, and one of the authors of the study.
Federal law does not require drug manufacturers to notify public about drug recalls
While there is no excuse for the FDA’s utter failure to effectively communicate 100 percent of serious drug recalls — after all, there were only 91 of them throughout an eight-year period — drug manufacturers are just as responsible for failing to notify healthcare providers and the public about serious drug recalls.
Since there are no laws requiring Big Pharma to disclose drug recalls, the public relies on the FDA, which is supposed to be a defender of public health, to get this information out quickly and effectively. Apparently the agency is too busy shutting down raw dairies and staging unlawful stings on family farms selling safe food to deal with drug recalls that affect millions of Americans.
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