FDA Drug Recall Notification System Failing Public

The Food & Drug Administration (FDA) doesn’t have the greatest reputation when it comes to effectively communicating drug recalls to physicians and the general public. An Archives of Internal Medicine study found that over an 8-year period the FDA failed to send out 20% of the most critical recall notices to the consuming public.

The FDA has two notification systems: the Recall Alert System and MedWatch Safety Alert. Class I recalls are the most serious and involve products and drugs whose continued use creates the greatest threat of severe health consequences or death. There were 42 drug recalls in 2011, an average of 3.5 drug recalls per month. In 2012 there have already been 28 drug recalls.

So what happens if a drug you take is on that recall list?  Do your doctor and pharmacist know if any of the drugs you take have been recalled? Do you?

The recall alert systems are inefficient and ineffective in several ways. A big part of the problem is information overload. Between 2004 and 2011, the FDA issued more than 2900 recalls. Most of these were Class II and III which involve recalls of a less serious and non-life threatening nature or concern food or veterinary drugs. There is no separate system or special alert for the most serious Class I recalls. Researcher Joshua Gagne explains, “It’s very possible that these important recalls are being lost in the less important ones.”

Another glaring problem is FDA inconsistency in reporting the most serious drug recalls. Researchers found that between 2004 and 2011, there were 91 Class I recalls but the FDA sent out only 55 of those alerts through the Recall Alert System, and another 18 alerts through MedWatch. 18 Class I recalls were never reported by the FDA through either alert system And although that number sounds small, what if you or a loved one were taking recalled medication or using a recalled medical device?

Researchers have several suggestions to make the recall notification system more effective. First, there should be special alerts for Class I drug recalls only. The FDA should also issue all drug recalls on both alert systems to ensure consistency. Researcher Gagne further recommends a computerized tracking system that communicates directly with pharmacists providing specific lot numbers and manufacturing dates of recalled drugs.

The FDA contends that the recall notification responsibility lies with the drug manufacturers themselves. Drug manufacturers sometimes send out recall notices to physicians but don’t always pass that information along to the FDA or the consuming public. Dr. Carl Furberg, a public health sciences professor at Wake Forest, explains, “The manufacturers should be ultimately responsible because the problem is with them. They should be the ones communicating about recalls.”

So, what should you do to protect yourself and your loved ones? Be proactive in your medical care. Ask questions of your doctor and pharmacist. Check the FDA website for recall notices or follow the FDA on Twitter or Facebook to get the latest information on recalled drug notices.

For more information on recalled drugs:

FDA: www.fda-gov/drugs/drugsafety/DrugRecalls

888-463-6332 or 301-796-3400

On Twitter: @FDA_Drug_Info