FDA Issues Safety Alert for Zecuity
June 2, 2016 – The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication about the possible severe side effects from using Zecuity® (sumatriptan iontophoretic transdermal system). Zecuity, manufactured by Teva Pharmaceuticals, is indicated to treat migraine headaches using a weak electric current to deliver sumatriptan through the skin and was introduced in the United States last September. The FDA has since received numerous reports from patients who have suffered burns or who have scars from the patches, despite being used according to the directions. The FDA advises patients who use Zecuity patches, if pain is felt at the place where the patch is applied to take it off at once and contact a healthcare provider. Patients also are reminded to use each Zecuity patch for only four hours or less and the patch, which uses batteries, should not get wet. Some patients may need to ask their prescribers about changing to another migraine medication.
As of June 10th Teva Pharmaceuticals has temporarily suspended marketing, sales and distribution of Zecuity patches and recommends that patients stop using Zecuity and request a different migraine drug from their physician. Providers not only should stop prescribing Zecuity, they should advise patients to stop using it, as well. Patients who may have had reactions should be evaluated by their doctor.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.