The US Food and Drug Administration (FDA) is looking into the risk for serious burns and potential permanent scarring wiUntitled design-3th the use of the sumatriptan transdermal patch Zecuity.

A single-use, battery-powered patch, Zecuity offers relief of migraine headache pain as well as migraine-relate nausea, was approved in 2013 for acute treatment of migraine with or without aura in adults.

“As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed,” the agency said. The FDA safety communication does not specify exactly how many patients have reported these adverse reactions.

Dr. Robbins’s comments: Once the patch came out, a # of reports indicated that patients had serious skin reactions(we do not know yet how serious); this was apparently known to the FDA but not to patients/prescribers, unfortunately. I think it was the right decision to pull the patch(it is possible they could fix it and re-introduce it, however). Some patients did like the patch; the effectiveness was fairly low, but it bypassed the GI tract and offered another option.

medscape.com

June, 2016

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