Teva halts migraine patch sales over burns

Teva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of serious burns with the use of the patch.

“Teva has received postmarketing reports of application site reactions described as ‘burn’ and/or ‘scar’ in patients treated with Zecuity. Patients described severe pain, itching or burning,” Teva said in a letter to healthcare providers. “Although many cases resolved within hours to weeks, there are reports of cases with unresolved skin reactions, typically skin discoloration, after several months.”

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Healthcare professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine, according to FDA. “Consider a different formulation of sumatriptan or switch these patients to an alternative migraine medicine. Evaluate patients and the application site as needed,” FDA said.

Meanwhile, FDA is investigating “these serious adverse events to determine whether future regulatory action is needed,” and will update the public with new information when its review is complete, the agency said.

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Healthcare providers and patients are encouraged to report adverse events in patients that have taken Zecuity to Teva Pharmaceuticals at (800) 896-5855. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, or regular mail, or by fax.

Visit www.fda.gov/medwatch/report.htm or call  (800) 332-1088 to request a reporting form.

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