Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA mulls warning on patches

This article was originally published in The Tan Sheet

Executive Summary

FDA may require a warning directly on transdermal patches with aluminized backing that says "remove before MRI," because the products could burn users' skin if worn during magnetic resonance imaging scans. While all OTC patches that currently contain metal components include a precautionary statement in the Drug Facts Labeling, FDA may require a warning on the patch itself because patients usually do not carry patch packaging when undergoing an MRI, the agency says March 5. "Two or three" reports of a "severe sunburn like reaction" when wearing a patch during an MRI prompted the agency to begin reviewing patch labeling and composition and consider an additional warning. Nicotine replacement patches - including Novartis Consumer Health's Habitrol Nicotine Transdermal System and several private label products that include aluminized polyester - are the only OTC patches potentially impacted by the possible change. The change also could impact Rx hormonal and pain patches, FDA says. The agency says fewer than 25 percent of the 60 OTC and Rx patch products contain metal, and 75 percent to 80 percent of those percent have adequate warnings





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts