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

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

User comments