From Our 2013 Archives
Dotarem Approved for Nervous System MRIs
THURSDAY, March 21 (HealthDay News) -- 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.
Latest MedicineNet News
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 central nervous system. All side effects were rare, the agency said, but the most common ones included nausea, headache, a burning sensation, and injection-site pain and coldness.
Dotarem is marketed by Guerbet LLC, based in Bloomington, Ind.
-- Scott Roberts
- Allergic Skin Disorders
- Bacterial Skin Diseases
- Bites and Infestations
- Diseases of Pigment
- Fungal Skin Diseases
- Medical Anatomy and Illustrations
- Noncancerous, Precancerous & Cancerous Tumors
- Oral Health Conditions
- Papules, Scales, Plaques and Eruptions
- Scalp, Hair and Nails
- Sexually Transmitted Diseases (STDs)
- Vascular, Lymphatic and Systemic Conditions
- Viral Skin Diseases
- Additional Skin Conditions