Effectiveness of FDA’s Drug Recall Alert System Called Into Question

Posted on June 5, 2012

A new study has shown that consumers might not be receiving the notification that they need in regards to drugs that have been recalled.

A group of researchers with Brigham and Women’s Hospital in Boston have looked at drug recall notices issued by the Food and Drug Administration between 2004 and 2011.  They uncovered a total of 1,700 such recalls, with 91 of those being of the Class I status, meaning that taking the drugs could result in the patient facing serious or life threatening consequences.  However, researchers discovered that only 55 of those 91 Class I recalls resulted in a safety alert being issued through the Recall Alert System.

MedWatch picked up some of the slack, with 18 more alerts being issued, but that still leaves an additional 18 potentially serious recalls that may not have been adequately reported.  The researchers published their findings in a letter sent to the Archives of Internal Medicine.  They voiced their concern that healthcare professionals may not be getting the recall information necessary to protect their patients.

Some have said that they would prefer to see some kind of tracking system put in place in order to keep tabs on drugs.  Without such a computerized system, it’s understandably hard for the FDA to have a grasp on every potentially dangerous drug out there.

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