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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.

Opioid Combinations

The FDA issued a Drug Safety Communication warning about the serious risks and death when combining opioid pain or cough medicines with benzodiazepines. The FDA is adding Boxed Warnings, their strongest warnings, to the drug labeling of prescription opioid pain and prescription opioid cough medicines, and benzodiazepines. Read the Alert.

Lamotrigine

On August 19, 2016, Impax Laboratories issued a voluntary recall for one lot of lamotrigine orally disintegrating tablet (ODT) 200mg. The affected lot, #502240, was distributed between June 13, 2016 and August 10, 2016. The blister packs may contain 100 mg product instead of 200 mg product. Each blister pack is properly labeled, however, the card is labeled incorrectly. Read the FDA Safety Alert.

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. 

FDA Drug Safety Labeling changes

On September 1, 2016 the FDA launched a database to provide the public with information on drug safety labeling changes. Search the Drug Safety Labeling Changes database

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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