The Food and Drug Administration, in a public health advisory issued Thursday, warned about risk of burns to patients who wear certain transdermal patches containing even small traces of aluminum or other metals in the adhesive backing during magnetic resonance imaging (MRI).

 

The warning comes from MedWatch, the FDA’s safety information and adverse event reporting system.

 

“The risk of using a metallic patch during an MRI has been well-established, but the FDA recently discovered that not all manufacturers include a safety warning with their patches,” said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a press release.

 

“Because the metal in these patches may not be visible and the product labeling may not disclose the presence of the metal, patients should tell both their health care professional and their MRI facility that they wear a medicated adhesive patch,” Woodcock added.

 

According to Sandra Kweder, deputy director in FDA’s Office of New Drugs, fewer than 25 percent of the 60 patches on the market have metal in them. She also said some patches that appear clear can contain a metal ion that could also cause a skin burn.

 

The FDA has received only a few reports of patients experiencing skin burns from patches such as Teva Pharmaceutical Industries Ltd.’s fentanyl patch. However, none of them were serious, but it is important to alert people about the risk for burns from wearing them in an MRI, Kweder said.

 

Anyone experiencing adverse events related to transdermal patches can report by telephone at 1-800-FDA-1088, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.