FDA warns of deadly side effect with imaging drugs

Sep 09, 2010 By MATTHEW PERRONE , AP Business Writer

(AP) -- Federal health regulators are warning doctors that a class of injectable drugs used in MRI medical imaging scans can cause a rare and sometimes fatal condition in patients with kidney disease.

The said Thursday it is adding its strongest warning label to imaging agents that contain the chemical gadolinium, indicating they should not be used in patients with kidney problems.

"These label changes are intended to help ensure these drugs are used appropriately," the FDA said in a posting to its website. The warning language will appear in a bolded box at the top of the drugs' labels.

The agency said in a statement that use of the drugs can lead to a rare syndrome that causes hardening of the skin and tissue growth along joints, eyes and internal organs. The ailment, which is sometimes fatal, is called nephrogenic fibrosing dermopathy and has been reported in patients with weakened kidney function.

There is no known treatment for the condition, though appears to slow disease and even reverse it in some cases.

Known as contrast agents, the products are used to improve clarity in medical scans of the heart, liver and other . The FDA has approved five such agents since 1988.

While the nephrogenic syndrome has been reported with all five drugs, the FDA said three have greater risks than the others: Bayer Healthcare's Magnevist, General Electric Healthcare's Omniscan and Covidien's Optimark.

The new FDA labels instruct physicians to screen patients for before administering the agents. The FDA said there haven't been any reports of the syndrome in patients with normal kidney function.

There are two non-gadolinium-based imaging agents on the market, though the FDA has approved them only for liver scans.

GE Healthcare said in a statement that the FDA's labeling reinforces physician guidelines that already stress the importance of screening for patients with kidney problems.

The company said MRI "continue to be a valuable diagnostic tool with a proven safety record for the overwhelming majority of patients to whom they are prescribed."

Explore further: FDA approves Eli Lilly's injectable diabetes drug

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

FDA wants MRI contrast agent warning

May 23, 2007

The U.S. Food and Drug Administration wants a warning printed on the labels of all gadolinium-based magnetic resonance imaging contrast agents.

New study suggests cause of debilitating skin condition

Sep 24, 2007

New findings from researchers at Wake Forest University Baptist Medical Center and colleagues suggest why some people with kidney failure can develop a rare tightening and swelling of the skin and other organs, including ...

FDA questions safety of Glaxo kidney cancer drug

Oct 01, 2009

(AP) -- Federal regulators said Thursday an experimental kidney cancer drug from GlaxoSmithKline may cause liver problems, potentially outweighing its ability to slow the disease.

Recommended for you

Experts want restrictions on testosterone drug use (Update)

Sep 17, 2014

Federal health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans ...

User comments : 0