Teva Pharmaceutical Industries, Ltd. announced that it will voluntarily suspend 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. In addition to this voluntary suspension, Teva has initiated a pharmacy-level recall of the product.
“At Teva, the wellbeing of people using our products is always the first priority. Given our deep commitment to patient safety, we will engage in a voluntary suspension of marketing while we continue our investigation into the root cause of these adverse skin reactions,” said Rob Koremans, M.D., President and Chief Executive Officer of Global Specialty Medicines at Teva. “We will continue to work closely with the FDA to resolve any remaining questions.”
Patients are advised to discontinue the use of ZECUITY and discuss alternative treatment options with their physicians. Teva has issued a Dear Health Care Provider Letter to alert the prescribing community.
Patients and health care providers 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.
About Teva
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva Pharmaceutical Industries Ltd.
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