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

December 31, 2012

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

• December 19, 2012: Pradaxa (dabigatran etexilate mesylate): FDA is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves.
• December 19, 2012: Incivek (telaprevir) In Combination with Drugs Peginterferon Alfa and Ribavirin (Incivek combination treatment): FDA received reports of serious skin reactions, some fatal, in patients taking the hepatitis C drug Incivek (telaprevir) in combination with the drugs peginterferon alfa and ribavirin (Incivek combination treatment). FDA is adding a boxed warning to the Incivek drug label stating that Incivek combination treatment must be immediately stopped in patients experiencing a rash with systemic symptoms or a progressive severe rash.
• December 19, 2012: Heparin: FDA is notifying health care professionals, caregivers, and patients about a change to the container and carton labels for heparin products. This label change will require manufacturers to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter (mL). These modifications will eliminate the need for health care professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of miscalculations that may result in medication errors.