NGC Update Service: March 16, 2015 ► U.S. Food and Drug Administration (FDA) Advisories

NGC Update Service: March 16, 2015

U.S. Food and Drug Administration (FDA) Advisories

• March 10, 2015: Treanda (bendamustine hydrochloride) Solution by Teva: FDA is warning health care professionals not to use Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTD), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). Most marketed CSTDs contain either polycarbonate or ABS and are not compatible with Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution). FDA is requiring label changes for both the solution and the powder formulations of Treanda to reflect safe preparation information.
• March 9, 2015: Chantix (varenicline): FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported. FDA has approved changes to the Chantix label to warn about these risks.
• March 3, 2015: Testosterone Products: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone.