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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

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