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Michael J. Duber and Brandon T. Duber

Is the FDA Slow in Communicating Dangerous Drug Info?

Jul 11, 2012 |

A new study finds that Drug Recall information is not being communicated to consumers – FDA blames manufacturers:

In a new study, published on June 4, 2012,  in the Archives of Internal Medicine, researchers found that the there may be some serious issues with the ways the FDA communicates prescription drug recall information.   

According to the study, FDA records show 1,734 drug recalls from 2004 to 2011; 91 of those recalls were tagged Class I recalls, meaning they had the greatest likelihood to cause patients serious harm,  even death. According to the study, the FDA issued official public notices for only about half of the drug recalls deemed the most serious.

According to Brigham and Women’s Hospital in Boston, Drug Recalls happen frequently in the United States– about once a month – and unfortunately the ways in which the FDA is communicating these recalls, “might not be enough to warn health care providers of important drug recall information.” (

Responding to the study, an FDA spokeswoman, Sarah Clark-Lynn said, “The recall system depends on full and open disclosure [by manufacturers], trust and the industry’s acceptance of its responsibilities to protect the public from volatile products.”  Clark-Lynn says The FDA attempts to use as many methods as possible to communicate the potentially dangerous information – such as email list serves, news releases and even Twitter and text messaging to get the word out.  However, it is not only their responsibility to make these recalls known.  The fact is, “The FDA has no legal authority to force companies to recall their products” (ABC News).

So while many people look to the FDA to primarily communicate info about drug recalls, Dr. Carl Furberg, professor of public health sciences at Wake Forest University, says the FDA doesn’t always have a good record of communicating efficiently with medical professionals and the publi, saying, “I think the manufacturers should be ultimately responsible because the problem is with them. They should be the ones communicating about recalls.”

The study also predicted, “that drug recalls weren’t usually limited to a few pills here and there. Of the Class I recalls from 2004 to 2011, 34 percent affected more than 100,000 units of a drug, and 64 percent of recalled drugs had been distributed nationwide. Forty percent of the recalls were because of contaminated drugs, and 25 percent of the drugs were recalled for having the wrong doses or release mechanisms. The rest were the result of product mix-ups or mislabeling” (ABC News).

While the FDA attempts to alert the public as best it can about drug recalls, there will never be a perfect scenario to get the word out. Make sure you continue to check back on our website and blog for the latest recalls.