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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.

Gadolinium-based Contrast Agents for MRI

On July 27, 2015 the FDA issued a drug safety communication on Gadolinium-based Contrast Agents (GBCA) for Magnetic Resonance Imaging (MRI).  The FDA recommended that to reduce the potential for gadolinium accumulation, health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary and urged them to reassess the necessity of repetitive GBCA MRIs in established treatment protocols.  Read the Full Drug Safety Communication.

Daytrana Patch® (methylphenidate transdermal system)

On June 24, 2015 the FDA issued a drug safety communication on Daytrana Patch® (methylphenidate transdermal system). FDA added a new warning to the drug label to address permanent loss of skin color (chemical leukoderma) that may occur with use of the patch for Attention Deficit Hyperactivity Disorder (ADHD). Read the Full Drug Safety Communication with pictures.

Potiga® (ezogabine)
On June 16, 2015, the FDA issued a drug safety communication on Potiga® (ezogabine). The FDA determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling, and to further explore any potential long-term consequences of these pigment changes, FDA has required the Potiga manufacturer, GlaxoSmithKline, to conduct a long-term observational study.  Read the Full Drug Safety Communication.

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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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