Friday, June 03, 2016 9:20:03 AM
By Jeff Overley
Law360, New York (June 2, 2016, 7:21 PM ET) -- The U.S. Food and Drug Administration on Thursday reported that “a large number of patients” have suffered severe burns and scars after using a migraine headache patch sold by Teva Pharmaceuticals and that the product’s safety is getting fresh scrutiny.
In a safety communication, the FDA said it is investigating reports of “serious burns and potential permanent scarring” in connection with Zecuity, a transdermal patch approved in 2013 for the treatment of migraines and launched in the U.S. in September.
The battery-powered patch is worn on the upper arm or thigh for up to four hours and delivers sumatriptan, a widely prescribed anti-migraine drug that’s been on the market for 25 years. Common side effects of Zecuity include skin redness and discomfort, but the FDA on Thursday described adverse events that have been much more alarming.
“The reports included descriptions of severe redness, pain, skin discoloration, blistering and cracked skin,” FDA officials said. “As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed.”
In a statement on Thursday, Israel-based Teva said it is “working closely with the FDA on the investigation.”
“At Teva, there is nothing more important to us than the health and safety of those who use our products,” the company said.
The agency said that patients should “immediately remove” Zecuity and contact a doctor if they experience moderate to severe pain at the application site. In such situations, a different drug or a different formulation of sumatriptan should be considered, according to the FDA.
Teva acquired Zecuity in 2014 when it purchased Pennsylvania-based NuPathe Inc. for nearly $115 million. The product’s main selling point is its ability to deliver sumatriptan into the bloodstream more quickly than pills by skipping the gastrointestinal tract.
Other skin patches have generated serious cosmetic concerns in the past. For example, the FDA last year warned that the Daytrana patch sold by Noven Pharmaceuticals Inc. to treat attention deficit hyperactivity disorder could cause permanent loss of skin color.
--Additional reporting by Dani Kass. Editing by Philip Shea.
Recent PATH News
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/09/2024 09:06:32 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 05/09/2024 09:00:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/08/2024 11:48:39 PM
- UiPath Announces First Quarter Fiscal 2025 Financial Results Conference Call • Business Wire • 05/08/2024 08:10:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/06/2024 08:22:35 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/06/2024 08:21:43 PM
- UiPath Named a Leader in the 2024 Gartner® Magic Quadrant™ for Process Mining • Business Wire • 05/02/2024 03:00:00 PM
- UiPath Announces Raghu Malpani Joins Company as Chief Technology Officer • Business Wire • 05/01/2024 12:00:00 PM
- UiPath Named a Leader for Second Consecutive Year in the Everest Group Intelligent Document Processing (IDP) Products PEAK Matrix® Assessment 2024 • Business Wire • 04/08/2024 12:00:00 PM
- UiPath Announces Sebastian Schrötel Joins Product Leadership Team to Lead UiPath Autopilot™ and Developer Experiences • Business Wire • 04/01/2024 12:00:00 PM
- UiPath Announces FedRAMP® Authorization for Its Automation Cloud™ Public Sector • Business Wire • 03/26/2024 12:00:00 PM
- UiPath Unveils New Family of LLMs at AI Summit to Empower Enterprises to Harness Full Capabilities of GenAI • Business Wire • 03/19/2024 12:00:00 PM
- Fisker’s Shares Take a Hit Amid Speculation of Bankruptcy, Altria Divests from AB InBev to Fund Stock Repurchase Initiative • IH Market News • 03/14/2024 11:39:32 AM
- UiPath Reports Fourth Quarter and Full Year Fiscal 2024 Financial Results • Business Wire • 03/13/2024 08:10:00 PM
- Mixed Futures Amidst Quiet Economic Schedule; Oil Prices Climb • IH Market News • 03/13/2024 11:03:39 AM
- Saudi Arabia Ministry of Tourism Boosts Vision for Excellence and Sustainable Growth with UiPath AI and Automation • Business Wire • 03/06/2024 01:05:00 PM
- UiPath Announces Investments in Saudi Arabia, Including First Saudi School of Automation and New Office Location in Riyadh • Business Wire • 03/04/2024 08:00:00 AM
- UiPath and Google Cloud Expand Strategic Partnership to Accelerate Access to Gen AI and Cloud-based Automation • Business Wire • 02/29/2024 01:00:00 PM
- UiPath to Exhibit AI-powered Automation Solutions for Healthcare Industry at ViVE 2024 Conference • Business Wire • 02/22/2024 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/21/2024 01:03:36 AM
- UiPath Announces New Developer Features at DevCon 2024 to Bring Latest in AI-powered Productivity to Developer Community • Business Wire • 02/16/2024 03:30:00 AM
- UiPath and Deloitte Collaborate to Introduce Turnkey Automation Offering for Growth Companies • PR Newswire (US) • 02/15/2024 09:30:00 PM
- UiPath Announces Fourth Quarter and Full Year Fiscal 2024 Financial Results Conference Call • Business Wire • 02/14/2024 09:10:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 10:25:30 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/05/2024 10:33:11 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM