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Will You Know Whether Your Prescription Medication Is Subject to a Major FDA Recall?

Every year some prescription drugs that patients are already taking are recalled from the U.S. market. The most serious of these FDA drug recalls are known as Class 1 recalls. A Class 1 recall is issued when a drug has the potential to cause serious adverse health consequences or death. Between 2004 and 2011, some 1,700 drugs were recalled, and 91 of those drugs were subject to a Class 1 recall. However, doctors, patients, and others may not have been properly informed of the Class 1 drug recalls according to a new study and that lack of information could put people at risk for serious injuries or death.

The FDA Failed to Issue Class 1 Drug Recall Alerts About 20 Percent of the Time

The FDA uses two notification systems to communicate with doctors and the public. Those notification systems include the Recall Alert System and MedWatch.

Between 2004 and 2011:

  • The FDA issued 2,900 announcements via the Recall Alert System.
  • There were 91 Class 1 drug recalls.
  • Only 55 of the 91 Class 1 drug recalls were reported via the Recall Alert System.
  • 18 of the remaining 36 Class 1 drug recalls were reported via MedWatch.
  • The remaining 18 Class 1 drug recalls were not reported via either system.

It is unclear why subscribers to the Recall Alert System and MedWatch are not notified of all Class 1 recalls. While doctors may be informed of serious recalls by letter directly from the pharmaceutical company or in other ways, not all subscribers would have access to that information.

Contact a Wisconsin Pharmaceutical Class Action Lawyer if You’ve Been Hurt by a Prescription Drug

Whether or not an FDA alert was properly issued, you may have the right to damages if you have been hurt by a prescription drug. For more information about your rights and potential recovery, please contact a lawyer who specializes in dangerous recalled drugs today for more information. We can be reached at 1-800-800-5678 or 414-223-4800.

Jason F. Abraham
Managing Partner, Hupy and Abraham