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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.

Phenobarbital

C.O. Truxton, Inc. issued a voluntary recall of lot 70952A of phenobarbital tablets, 15 mg after receiving a confirmed complaint a bottle was found to contain phenobarbital 30 mg tablets. Read the full FDA Safety Alert

StrataMR Adjustable Valves and Shunts

Medtronic issued a voluntary recall of all unused units of the StrataMR adjustable valves and shunts. This voluntary recall is due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid. Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting, and lethargy. If left untreated, under-drainage can potentially lead to coma and death. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata II or Strata NSC products. Read the FDA alert.

Balloon angioplasty devices to treat autonomic dysfunction

The FDA issued a Safety Communication alerting individuals to the potential risk of using an experimental procedure called Transvacular Autonomic Modulation (TVAM). The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use. This procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials.The FDA has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for use for patients with autonomic dysfunction, including but not limited to Parkinson's disease, multiple sclerosis (MS), fibromyalgia, multiple system atrophy, postural tachycardia syndrome (POTS), peripheral neuropathies, primary dysautonomia, familial dysautonomia. Read the 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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