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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.

Gilenya (fingolimod)

On August 4, 2015, the FDA issued as drug safety communication that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking fingolimod for multiple sclerosis (MS). Read the FDA Drug Safety Communication.

Brintellix and Brilinta Name Confusion

The US Food and Drug Administration has issued a warning for health care professionals that reports of confusion between the antidepressant Brintellix (vortioxetine) and anti-blood clotting medication Brilinta (ticagrelor) have resulted in the wrong medication being prescribed or dispensed. Heath care professionals can reduce the risk of name confusion by including the generic (established) name of the medication, in addition to the brand name, and the indication for use when prescribing these medications. Read the FDA Drug Safety Communication.

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.

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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