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Warning on Transdermal Patches, MRIs

Mar 6, 2009 | Parker Waichman Alonso LLP

The U.S. Food and Drug Administration (FDA) has just issued information regarding the use of transdermal patches when undergoing MRI testing.  The medicated patches, which are applied to the skin and that contain aluminum or other metals in the backing of the patches, can contain metal which can overheat during an MRI scan and which can cause skin burns in the immediate area of the patch.

The patches are meant to slowly deliver medication transdermally, or through the skin.  But, some transdermal patches contain metal in the layer of the patch—generally the backing—that is not in contact with the skin and is not always visible.  The labeling for most of the medicated patches that contain metal in the backing provides a warning to patients about the risk of burns if the patch is not removed before an MRI scan; however, not all transdermal patches that contain metal contain these warning labels, said the FDA.

The FDA is currently in the process of reviewing the labeling and composition of all such medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan.

Until the agency’s review is complete, it recommends that healthcare professionals referring patients for an MRI scan identify those patients who are wearing a patch before the scan conducted and to advise those patients about how to remove and dispose of the patch before undergoing the MRI scan, and how to replace the patch following the scan.

The FDA suggests that MRI facilities follow published safe practice recommendations concerning patients who are wearing patches (Kanal, et. al, “ACR Guidance Document for Safe MR Practices: 2007,” AJR 2007; 188:1–27 and Guidelines for Screening Patients For MR Procedures and Individuals for the MR Environment, Institute for Magnetic Resonance Safety, Education, and Research, www.imrser.org, 2009) and, until the safety issue is resolved, recommends the following for patients who use any type of medicated patch, including nicotine patches:

• Advise the referring physician that you are using a patch and for what use the patch has been prescribed, such as for pain, smoking cessation, or hormone therapy, for example.
• Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure.
• Tell the MRI facility—at the time you make your appointment and when you provide answers to health history questions—that you are using a patch.
  

The FDA is also urging health care professionals and patients to report possible cases of skin burns while wearing patches during an MRI to the FDA through its MedWatch program.  MedWatch can be reached by telephone toll-free at 1-800-FDA-1088 or via the Internet at http://www.fda.gov/medwatch/index.html.