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Drug and Device Safety

Keep up to date with recent drug alerts and through the FDA drug alert system and Vaccine Adverse Event Reporting System (VAERS)

Recent Drug Alerts

Learn more about recent FDA drug safety alerts and communications that may impact your patients.

Zecuity
  • The FDA issued a drug safety communication warning that it is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. The FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is completed. Read the Full FDA alert.
  • On June 13, 2016 the FDA issued an updated drug safety communication indicating Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Read the UPDATED FDA alert. 
Olanzapine

The FDA issued a drug safety communication warning that olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body. The condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) was reported in 23 cases since 1996. DRESS may start as a rash that can spread to all parts of the body, and can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death. DRESS is a potentially fatal drug reaction with a mortality rate of up to 10%. Read full FDA alert. 

Vortioxetine

The FDA issued a drug safety communication highlighting the name change for Brintellix (vortioxetine). FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016. No other changes will be made to the label or packaging, and the medicine is exactly the same. Read the full FDA alert.

Free FDA Email Alert Notifications

MedWatch is the FDA Safety Information and Adverse Event Reporting Program. You can subscribe to MedWatch Safety Alerts for email alerts or follow MedWatch on Twitter.

Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a national passive surveillance system that monitors the safety of all vaccines licensed for use in the United States. VAERS reports are available through CDC WONDER. All personal identifying information is removed prior to posting the public data.


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