2017-06-02 17:26:17 - 8

FDA claims no proven effects of brain gadolinium deposits

A Food and Drug Administration (FDA) of the USA published, on May 22, a review informing that there is no evidence that the gadolinium that remains in the body after the administration of contrast in MRI exams has negative effects on health. However, according to the document, the announcement is unlikely to end the debate over the safety of gadolinium contrast. In a safety announcement, the FDA said its review identified "no harmful effects to date" from brain retention of gadolinium-based contrast agents. Thus, the agency concluded that it was not necessary to insert new restrictions on gadolinium contrast products. The FDA's move puts the agency at odds with the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), which in March recommended that four linear gadolinium contrast products be withdrawn from the market. The FDA review reinforced the established correlation between brain gadolinium deposits and exposure to non-macrocyclic linear presentations, but without proven health effects. Source: Aunt Minnie