Blog | Friday, June 8, 2012

QD: News Every Day--What happens if a drug is recalled but nobody is told?


Important drug recalls occur monthly, yet many are never reported to physicians, researchers concluded.

Two pharmacists and Niteesh K Choudhry, MD, ACP Member, tallied all drug recalls in the United States between 2004 and 2011 and cross-referenced Class I recalls (the most important) with the FDA Recall Alert System and with the FDA's MedWatch.

Results appeared in a research letter that appeared online June 4 at Archives of Internal Medicine. Between 2004 and 2011, there were 1,734 drug recall entries in the FDA Enforcement Reports; 91 were Class I (5%).

During this same period, the FDA issued 2,912 recall announcements, of which 166 were major human drug recall announcements for 126 unique products, the authors reported. Only 55 of these 126 were Class I recalls (47%). No recall notice occurred for 36 Class I recalls (40%), although half of these did appear in MedWatch, including all 5 recalls triggers by adverse events.

But 18 of 91 (20%) Class I recalls were not communicated through either system.

"As the main mechanism of communicating recall information, the Recall Alert System should notify health care providers of all clinically important human medical product recalls," the authors wrote.

But Class I recalls come down the same reporting pipeline used for veterinary drug recalls, making it tough for doctors to sort through the most important ones. And, there is no mechanism for reporting lots of drugs or their location in the supply chain.