Teva To Voluntarily Suspend ZECUITY In U.S. For Adverse Skin Reactions

(RTTNews) - Teva Pharmaceutical Industries Ltd. (TEVA) announced Monday 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. The company said it is working in full cooperation with the U. S. Food and Drug Administration to better understand these adverse events.

In addition to this voluntary suspension, Teva has initiated a pharmacy-level recall of the product.

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.

Rob Koremans, M.D., President and Chief Executive Officer of Global Specialty Medicines at Teva, said, "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."