A surprising one in five drug recalls of the most serious type (Class I) were never formally announced or communicated to doctors by the FDA, according to the results of a report published in the Archives of Internal Medicine. The agency has two systems in place the Recall Alert System and Medwatch that it uses to send out notifications to doctors and patients about drug recalls and, while recalls may vary in their degree of danger, Class I recalls are reserved for those drugs that, if taken, have the potential to cause serious adverse health consequences or death.
But according to researchers from Brigham and Women s Hospital in Boston, 18 out of the 91 Class I recalls issued between 2004 and 2011 were never reported through either alert system. And as study author Dr. Joshua Gagne points out, there s no way of knowing whether the lack of notifications was linked to any patient harm.
But ACSH's Dr. Gilbert Ross believes that surely they were, and the FDA s negligence is responsible. The mind boggles to think that our premier drug regulator is unable to correlate important adverse drug information with simple communications, he added.
Though it s unclear why these notifications were never sent out, Dr. Gagne does suggest that the tracking could all be computerized so that pharmacies can know which bottles the recalled products came from.
