Dotarem approved for nervous system MRIs

(HealthDay)—Dotarem (gadoterate meglumine) has been approved by the U.S. Food and Drug Administration as a contrast agent for use in MRIs of the brain, spine and other parts of the central nervous system.

Approved for people two years and older, the imaging agent helps radiologists detect lesions and other abnormalities. Dotarem and similar agents all carry a boxed label warning of the risk of nephrogenic systemic fibrosis, a rare yet dangerous condition that can develop in people with kidney disease, the FDA said in a news release. The condition is characterized by pain and thickening of the skin.

Dotarem's safety and effectiveness were evaluated in clinical studies involving 245 adults and 38 children with suspected abnormalities of the . All side effects were rare, the agency said, but the most common ones included nausea, headache, a , and injection-site pain and coldness.

Dotarem is marketed by Guerbet LLC, based in Bloomington, Ind.

More information: The FDA has more about this approval.

add to favorites email to friend print save as pdf

Related Stories

Iclusig approved for rare leukemias

Dec 16, 2012

(HealthDay)—Iclusig (ponatinib) has been approved by the U.S. Food and Drug Administration to treat two rare forms of leukemia..

Marqibo approved for rare leukemia

Aug 10, 2012

(HealthDay) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with a rare form of blood and bone marrow cancer, Philadelphia chromosome negative ...

Drug OK'd for deadly genetic condition tied to cholesterol

Jan 30, 2013

(HealthDay)—Kynamro (mipomersen sodium) has been approved by the U.S. Food and Drug Administration to treat a rare inherited condition in which the body can't remove low-density lipoprotein (LDL) cholesterol from the blood.

Marqibo approved for ph- acute lymphoblastic leukemia

Aug 10, 2012

(HealthDay) -- Marqibo (vincristine sulfate liposome injection) has been approved by the U.S. Food and Drug Administration to treat adults with Philadelphia chromosome negative acute lymphoblastic leukemia ...

Gattex approved for short bowel syndrome

Dec 22, 2012

(HealthDay)—Gattex (teduglutide) has been approved by the U.S. Food and Drug Administration to treat nutritional problems caused by short bowel syndrome.

Recommended for you

Flu vaccine for expectant moms a top priority

11 hours ago

Only about half of all pregnant women in the U.S. get a flu shot each season, leaving thousands of moms-to-be and their babies at increased risk of serious illness.

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