Study: U.S. Drug Recalls Common But Not Well Publicized

By Andrew M. Seaman | June 6, 2012

The U.S. Food and Drug Administration recalls potentially harmful drugs about once every month but could do a better job of letting doctors and patients know about them, according to a study released on Monday.

Over an eight-year span, researchers found that the FDA failed to send notifications for one in five of the most serious category of recalls through its two electronic systems used to alert doctors and the public. Results of the study were published in the Archives of Internal Medicine.

The so-called Class I recalls, according to the FDA, are issued for drugs that, if taken, have the potential to cause “serious adverse health consequences or death.” An example is the 2008 recall of contaminated blood thinner heparin, which had caused serious reactions and some deaths in dialysis patients and was reported by the FDA.

“A good system would indicate all of the Class I recalls, and it wouldn’t necessarily communicate recalls the FDA deems less important, such as Class II and Class III,” said Joshua Gagne, from Brigham and Women’s Hospital in Boston.

Between 2004 and 2011, Gagne and his fellow researchers counted more than 1,700 drug recalls listed in the FDA’s enforcement reports. Of those, 91 were serious Class I recalls.

During that time, the FDA issued about 2,900 announcements through the Recall Alert System, which sends notifications to subscribers about recalled drugs and products. The system, however, sent alerts for only 55 of the 91 Class I recalls.

MedWatch, another system used by the FDA to report drug recall information, sent alerts for 18 of the remaining recalls. Another 18 — or one-fifth — of the Class I recalls were never reported through either system.

“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,” the authors wrote in a letter to the Archives of Internal Medicine.

An FDA spokeswoman said there are a number of ways the agency communicates with doctors, but was not able to say why notifications were not sent in 18 cases of Class I recalls.


There is no way to know if the lack of notifications was linked to any patient harm, Gagne said. He added that the FDA has moved to address communication problems, including recall notifications.

“It’s certainly on their radar and they’re constantly starting initiatives to address it, but there is still room for improvement,” he said.

Dr. Lisa Schwartz, co-director of the Center for Medicine and Media at the Dartmouth Institute in Lebanon, New Hampshire, told Reuters Health that the FDA should make sure people are notified about all Class I drug recalls until there is a nationwide system that allows the agency to track individual packages of recalled drugs.

“It’s unclear why it shouldn’t be 100 percent of the time they’re notifying people on both systems,” said Schwartz, who was not involved in the new study.

The FDA favors a tracking system that would scan medicine bottles individually, but has met with resistance from manufacturers, distributors and pharmacies over how to cover the cost of such a program.

In any case, the FDA needs “a more specific system that only communicates all of the Class I information,” Gagne said, rather than the current system that spans recalls on everything from medical devices to food and veterinary drugs.

(Editing by Ivan Oransky, Michele Gershberg and Dan Grebler)

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