ZECUITY® (SUMATRIPTAN IONTOPHORETIC TRANSDERMAL SYSTEM)

SUSPENSION OF MARKETING

Teva Pharmaceuticals has voluntarily suspended sales, marketing and distribution of ZECUITY (sumatriptan iontophoretic transdermal system). Teva has received post-marketing reports of application site reactions described as burns and scars in patients treated with ZECUITY, and is working in full cooperation with the U. S. Food and Drug Administration (FDA) to better understand these adverse events.

Patients are advised to discontinue the use of ZECUITY and discuss alternative treatment options with their physicians.

Health Care Professionals click here to view the Dear Health Care Provider Letter that Teva has issued regarding the market suspension.

Patients and Health Care Professionals should report any suspected adverse events to Teva at 1-800-896-5855 or to FDA at 1-800-FDA-1088. 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 at: www.fda.gov/medwatch/report.htm.

Full Prescribing Information for ZECUITY