When potentially dangerous drugs are recalled, patients expect to be notified, especially when the drugs could harm their health. However, a new study found that the Food and Drug Administration (FDA) failed to notify the public of some of its most urgent drug recalls.
According to the study, published in the Archives of Internal Medicine, the FDA did not send notifications for 20 percent of drugs included in its most serious class recalls. Researchers noted that of the 91 Class I recalls declared by the FDA, 18 were never reported to the public through the FDA's Recall Alert System or MedWatch Safety Alert database. According to the FDA, Class I recalls are issued for drugs that, if taken, could potentially lead to serious adverse health consequences or death.
In response, the FDA issued a statement saying that it uses many other methods for communicating information about drug recalls than the two evaluated in the study. These methods include email lists, news releases, Twitter, and text messaging. The FDA also noted that the recall system depends on the full disclosure of manufacturers because the agency has no legal authority to force companies to recall their products.