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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.

FindrWIRZ

The FDA issued a Drug Safety Communication announcing a recall of SentreHeart's FindrWIRZ Guidewire System. The polytetrafluoroethylene (PTFE) coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. Coating separation may be caused by issues with the device design or manufacturing processes. Lot Numbers 01160568, 02160586, 07160639 -150, distributed between June 1, 2016 - September 26, 2016 and manufactured between January 4, 2016 - July 22, 2016 are affected. Read the FDA Alert.

Medtronic Neurovascular Products

The FDA issued a Drug Safety Communication announcing a voluntary recall of Medtronic Neurovascular Products, including:

i. Pipeline Embolization Device
ii. Alligator Retrieval Device
iii. X-Celerator Hydrophilic Guidewire

iv. Ultraflow and Marathon Flow Directed Micro Catheters

This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event. 84,278 units potentially affected by this recall had been distributed worldwide, and were manufactured from July 2014 to September 2016. Read the FDA Alert.

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.

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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