The U.S. Food & Drug Administration (FDA) does a poor job publicizing drug recalls, according to a new study.
Although the agency announces recalls of potentially dangerous drugs each month, they are not alerting doctors and patients as well as they could, according to the study, said FoxNews. The researchers discovered that, over eight years, the FDA did not send notifications for one out of five of the most serious recalls through its two electronic systems used to advise physicians and the public.
Class I recalls, according to the FDA, are issued for recalled drugs that, if taken, could potentially lead to “serious adverse health consequences or death,” said FoxNews. “I think 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,” Joshua Gagne, of Brigham and Women’s Hospital in Boston, told Fox News.
Gange and his research team counted over 1,700 drug recalls between 2004 and 2011 that were indicated in the FDA’s enforcement reports. Of these, 91 were deemed Class I. During that time, the FDA issued some 2,900 announcements through the Recall Alert System; however only 55 were associated with the 91 Class I recalls, said Fox News.
While MedWatch, another system used by the agency to report drug recall information, issued alerts for 18 of the remaining recalls, another 18—1/5th—of the Class I recalls were not reported through either system, FoxNews explained.
“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 study authors wrote in a letter to the Archives of Internal Medicine.
An FDA spokesperson told Reuters Health that there are a variety of methods in which it communicates with physicians, but could not say why no notification was issued in the 18 cases, said Fox News. Gange pointed out that there is no way to determine if the lack of notifications were associated with patient harm, FoxNews added.
Grange did say that the FDA is working on communications issues that include 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, wrote FoxNews.
“It’s unclear why it shouldn’t be 100 percent of the time they’re notifying people on both systems,” Dr. Lisa Schwartz, co-director of the Center for Medicine and Media at the Dartmouth Institute in Lebanon, New Hampshire, who was not involved in the study, told Reuters Health. “The tracking could all be computerized so pharmacies can know which bottles the recalled products came from,” Gagne told Fox News. The FDA’s automatic email notices about recalls are available at 1.usa.gov/MbBGEu or on Twitter at @FDArecalls, said FoxNews.
We previously wrote that other research revealed that FDA warnings are not always effective. The study, published in the journal, Medical Care, involved a review of warnings about serious adverse events, recommendations against drug use in specific patient populations, cautions regarding drug-drug interactions, and calls for increased laboratory or clinical monitoring.
