FDA Warns Of Burn Risk From Wearing Medicated Patches During MRI

Tuesday, 17th March 2009

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Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety.

The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration recently.

FDA Public Health Advisory
Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings

The FDA has been made aware of information about certain transdermal patches (medicated patches applied to the skin) that contain aluminum or other metals in the backing of the patches.

Patches that contain metal can overheat during an MRI scan and cause skin burns in the immediate area of the patch.

Transdermal patches slowly deliver medicines through the skin. Some patches contain metal in the layer of the patch that is not in contact with the skin (the backing). The metal in the backing of these patches may not be 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 have this warning for patients in the labeling.

FDA is in the process of reviewing the labeling and composition of all 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 this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan.

The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.1,2

Until this safety issue is resolved, FDA recommends that patients who use medicated patches (including nicotine patches) do the following:

* Tell the doctor referring you for an MRI scan that you are using a patch and why you are using it (such as, for pain, smoking cessation, hormones)

* 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 that you are using a patch. You should do this when making your appointment and during the health history questions you are asked when you arrive for your appointment.

The FDA urges health care professionals and patients to report possible cases of skin burns while wearing patches during an MRI to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html.

(1) Kanal, et. al, “ACR Guidance Document for Safe MR Practices: 2007,” AJR 2007; 188:1–27.
(2) 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.

Update: (03/9/2009) FDA has evaluated the composition of available patches to determine which of them contain metal components and to assure that this information is included in their labeling. Based on current information from this evaluation, FDA is working with the manufacturers of the following patches to update the labeling to include adequate warnings to patients about the risk of burns to the skin if the patch is worn during an MRI scan. It should be noted that some of the drugs listed may have a generic equivalent and more than one size and strength of patch. FDA will update this posting as information becomes available.

Proprietary Name Generic/Established Name

Catapres TTS Clonidine

Neupro Rotigotine

Lidopel Lidocaine HCl and epinephrine

Synera Lidocaine/Tetracaine

Transderm-Scop Scopolamine

Prostep Nicotine transdermal system

Habitrol Nicotine transdermal system

Nicotrol TD Nicotine transdermal system

Androderm Testosterone transdermal system

Fentanyl Fentanyl

Salonpas Power Plus Methyl Salicylate/Menthol

6 Comments to 'FDA Warns Of Burn Risk From Wearing Medicated Patches During MRI'

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  1. […] FDA Warns of Burn Risk From Medicated Patches During MRI | Utah … […]

    Tue 17th March, 2009 at 5:25 pm
  2. Tobias Gilk said:

    For MRI safety and transdermal medication patches, you may be interested in a post on my blog (http://mrimetaldetector.com/blog/?p=348) highlighting some critical mis-information.

    Wed 18th March, 2009 at 8:01 am
  3. Utah-Per said:

    Thanks for the heads up!

    Wed 18th March, 2009 at 12:13 pm
  4. mark said:

    I bookmarked this site, Thank you for good job!

    Wed 15th April, 2009 at 12:34 am
  5. This topic is quite hot in the net right now. What do you pay the most attention to while choosing what to write ?

    Wed 15th April, 2009 at 11:22 am
  6. mark said:

    Thanks for the review!

    Thu 16th April, 2009 at 5:15 am

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