Other safety alerts
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| The United States: Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA evaluating risk of burns and scars |
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The Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete.
The Zecuity patch contains the active ingredient sumatriptan, a prescription medicine used to treat acute migraine headaches in adults. The patch delivery system is designed to deliver a dose of medicine by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh. It should remain in place for no longer than four hours.
Patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact their health care professional. Do not bathe, shower, or swim while wearing the patch.
Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the Zecuity patch immediately. Consider a different formulation of sumatriptan or switch these patients to an alternative migraine medicine. Evaluate patients and the application site as needed.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm504736.htm
In Hong Kong, the above product is not a registered pharmaceutical product, and there is no registered pharmaceutical product containing sumatriptan in transdermal patch dosage form.
Ends/ Friday, June 03, 2016
Issued at HKT 14:00
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