NEWS - FDA warns of burns during MRI from some drug patches

[Guest guest]

FDA Warns of Burns During MRI From Some Drug Patches

By JENNIFER CORBETT DOOREN

MARCH 5, 2009, 1:10 P.M. ET

WASHINGTON -- The U.S. Food and Drug Administration Thursday warned of

the risk of skin burns in patients wearing transdermal drug patches

who are undergoing MRI scans.

Transdermal patches are applied to the skin and can be used to deliver

pain medications, hormones and nicotine.

Most of the patches are sold by prescription except for nicotine

patches, which are available over-the-counter.

In a public health advisory issued Thursday, the FDA said certain

patches contain aluminum or other metal in the backing of the patches

which can overheat during an MRI scan and cause skin burns in the

immediate area of the patch.

Kweder, deputy director in FDA's Office of New Drugs, said

there are about 60 patches on the market and fewer than 25% of such

products have metal in them. She also said some patches that appear

clear can contain a metal ion that could also cause a skin burn.

FDA officials said they received two or three reports of skin burns

akin to a severe sun burn in patients who wore over-the-counter

nicotine patches and underwent an MRI and are investigating a handful

of other reports.

Ms. Kweder said the agency is currently reviewing all skin patches and

will require those which contain metal to have a warning placed

directly on the patch that would likely state, " remove before MRI. "

While most of the packaging for patches with metal contains a warning

to remove the patch before undergoing an MRI, the agency found that

some products, such as Teva Pharmaceutical Industries Ltd.'s fentanyl

patch, were missing the warning.

Ms. Kweder also noted that most patients likely won't have the package

with them while undergoing the MRI, which is why the agency will

require a warning directly on the product as well as on the package.

But until the new labeling is adopted, the FDA said patients and MRI

operators should be aware of the risk of skin burns.

The agency said most MRI facilities ask patients whether they are

wearing any patches but said patients should also inform health-care

professionals when making an appointment for the scan and before

undergoing the MRI.

http://online.wsj.com/article/SB123627293447941721.html

Not an MD

[Guest guest]

When I had my MRI recently, they didn't ask if I was wearing any

patches. Fortunately, I was not wearing any.

Sue

On Mar 8, 2009, at 11:53 AM, wrote:

>

> The agency said most MRI facilities ask patients whether they are

> wearing any patches but said patients should also inform health-care

> professionals when making an appointment for the scan and before

> undergoing the MRI.

[Guest guest]

Good thing, Sue!

Not an MD

On Sun, Mar 8, 2009 at 4:03 PM, marysue <marysue@...> wrote:

> When I had my MRI recently, they didn't ask if I was wearing any

> patches. Fortunately, I was not wearing any.

>

> Sue