sutures newsletter

PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY January 2018 | Archived Issues

FDA Issues New Safety Measures for Gadolinium-Based Contrast Agents

The U.S. Food and Drug Administration (FDA) is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging because of concerns about gadolinium remaining in patients' bodies, including the brain, for months to years. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and the FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

The FDA website has more information.

FDA: Agency Removes Warning About Asthma-related Death

The FDA is removing its most prominent warning about asthma-related death from the drug labels of medicines that contain both inhaled corticosteroids (ICS) and long-acting beta agonists. A review of four large clinical-safety trials showed that treating asthma with long-acting beta agonists in combination with inhaled corticosteroids does not result in significantly more serious asthma-related side effects than treatment with ICS alone.

The FDA website has more information.