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FDA Warns of Burns and Scarring With Zecuity Migraine Patch

Battery-powered system delivers sumatriptan through the skin

The FDA is investigating the risk of serious burns and potential permanent scarring with the use of the Zecuity (sumatriptan) iontophoretic transdermal patch (Teva Pharmaceuticals) for migraine headaches. Since marketing of the Zecuity patch began in September 2015, numerous patients have reported that they experienced burns or scars on the skin where the patch was worn, according to the agency. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin.

The FDA is investigating these serious adverse events to determine whether future regulatory action is needed.

The Zecuity patch contains the active ingredient sumatriptan, a prescription medication used to treat acute migraine headaches in adults. The Zecuity system is designed to deliver a dose of medication by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh. The patch should remain in place for no longer than four hours.

Health care professionals should advise patients who report moderate-to-severe pain at the application site to remove the Zecuity patch immediately. Clinicians should consider a different formulation of sumatriptan or switch these patients to an alternative migraine medication.

The Zecuity system delivers sumatriptan using iontophoresis—a noninvasive method of delivering a drug through the skin using a low electrical current. The Zecurity electronics, powered by two coin-cell lithium batteries, control the amount of current applied and the rate and amount of sumatriptan delivered. Sumatriptan succinate, the active component of Zecurity, is a selective 5-hydroxytryptamine receptor subtype 1 (5-HT1) agonist (triptan)

Zecuity transdermal patches are indicated for the acute treatment of migraine with or without aura in adults. The patches are not intended for the prevention of migraines. The patches are designed for patient self-administration to the upper arm or thigh. They should not be applied to other areas of the body.

In two long-term, open-label studies in which patients were allowed to treat multiple migraine attacks for up to one year, 15% (99/662) withdrew from the study because of an adverse event. The most common adverse events leading to withdrawal from the study were contact dermatitis (4%) and application-site pain (4%). The most common adverse events in a controlled single-dose study included application-site pain, paresthesia, pruritus, warmth, and discomfort.

Sources: FDA; June 2, 2016; and Zecuity Prescribing Information; April 2014.

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