The FDA approves Dotarem (gadoterate meglumine) as a contrast agent for use in MRIs of the brain, spine and other parts of the central nervous system. According to reports from the federal agency, the “imaging agent” is approved for people who are two years and older and will help radiologists and health care professionals detect lesions and other abnormalities in brain, spine and other parts of the central nervous system.

Dotarem is marketed by Guerbet LLC, based in Bloomington, IN. However, according to the agency the marketers of the imaging agents will have to 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. This condition is characterized by pain and thickening of the skin.

The safety and efficacy of the imaging agent Dotarem was established in a randomized, open and placebo-controlled clinical trial involving 38 children and 245 adults suffering from CNS abnormalities. Some of the side effects that people may experience after having used this agent include Nausea, burning sensation, headache and pain at the site of the injection.

While discussing about the approval of the agent with media persons and health care professionals Dwaine Rieves, M.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research said “Dotarem was shown to be a safe and effective magnetic resonance imaging agent in patients aged 2 years and older,” He also added that “Today’s approval provides doctors with another option to help evaluate anatomic abnormalities within the central nervous system.”

According to the reports from the agency Dotarem is the seventh GBCA approved by the FDA for use in patients undergoing CNS MRI. Some other GBCAs that were approved by the federal agency are:

  • Magnevist (1988)
  • Prohance (1992)
  • Omniscan (1993)
  • Optimark (1999)
  • Multihance (2004)
  • Gadavist (2011)

Precautions to be taken while using Gadolinium-based contrast agents (GBCAs)

Patients should be screened for acute kidney injury and other conditions that may impair renal function: Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Health care professionals and medical practitioners should avoid these agents on people who have compromised kidney functions as it may cause fatal or debilitating fibrosis affecting the internal organs, muscles and skin of the patient.