December 17, 2012
New research review! Visit the AHRQ Evidence Reports page for a listing of reports produced under AHRQ's Evidence-based Practice Program and Effective Health Care Program.
- The Guidelines International Network North America (G-I-N NA) continues to sponsor a monthly webinar series on topics of interest to the North American guideline community. Information on upcoming webinars, as well as audio files and slides from past webinars, is available on the G-I-N Web site .
U.S. Food and Drug Administration (FDA) Advisories
- 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.
- December 17, 2012: Xyrem (sodium oxybate) : FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression). The use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs (drugs that affect the CNS and may lead to breathing problems) such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided.