The US Food and Drug Administration (FDA) is looking into the risk for serious burns and potential permanent scarring with the use of the sumatriptan iontophoretic transdermal patch (Zecuity, NuPathe Inc) for migraine, the agency said in a June 2 drug safety communication.
Zecuity, a single-use, battery-powered patch, offers relief of migraine headache pain as well as migraine-related nausea,was approved in 2013 for acute treatment of migraine with or without aura in adults.
According to the FDA, since the product came on the US market in September 2015, a "large number" of patients have reported sustaining burns or scars on the skin where the patch was worn. The reports include severe redness, pain, skin discoloration, blistering, and cracked skin.
"As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed," the agency said. The FDA safety communication does not specify exactly how many patients have reported these adverse reactions.
While the investigation is going on, patients who report moderate to severe pain at the application site should be advised to remove the patch immediately, the FDA said. Using a different formulation of sumatriptan or switching these patients to an alternative migraine medicine should also be considered.
The FDA urges healthcare providers to report possible side effects involving the Zecuity patch to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
The FDA has approved sumatriptan nasal powder (Onzetra Xsail/Avanir Pharmaceuticals) for treating of adults suffering from acute migraines with or without aura. The low dose (22mg) of sumatriptan powder is delivered through the Xsail Breath Powered Delivery Device. According to Roger K. Cady, MD, director of the Headache Care Center and associate executive chairman of the National Headache Foundation, “The Xsail Breath Powered Delivery Device allows the medication to be deposited deep into the nose, an area hat is rich with blood vessels. B delivering the medication here, Onzetra Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limited the amount of medicine that goes down the back of the throat.” Onzetra is not indicated for migraine attack prevention and is contraindicated in patients with a history of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine, peripheral vascular disease, ischemic bowel disease, or uncontrolled hypertension. The most commonly reported adverse events included abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.ReplyDelete
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Teva Pharmaceuticals has decided to voluntarily suspend sales, marketing, and distribution of its sumatriptan patch (Zecuity) in order to investigate the root cause of adverse skin reactions associated with application of this product, said a US Food and Drug Administration (FDA) MedWatch alert released today.ReplyDelete
The FDA announced June 2 that it is investigating the risk for serious burns and potential permanent scarring with the use of the product.
"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 MedWatch alert notes. "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."
Healthcare professionals should discontinue prescribing Zecuity, which is indicated for the acute treatment of migraine with or without aura in adults, said the letter, signed by Denisa Hurtukova, MD, vice president, North American Medical Affairs, Teva Pharmaceuticals.
As well, patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine, said the letter.
Postmarketing reports of application site reactions have been described as severe redness, cracked skin, blistering or welts, and burns or scars where the patch is worn. Patients have described severe pain, itching, or burning.
Although most cases resolved within hours to weeks, cases of unresolved skin reactions, typically skin discoloration, after several months were reported, said the Teva letter.