martes, 6 de octubre de 2015

NGC Update Service: October 5, 2015 ► U.S. Food and Drug Administration (FDA) Advisories

NGC Update Service: October 5, 2015

National Guideline Clearinghouse (NGC)

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

  • September 21, 2015Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger: FDA is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. This risk may be increased in children treated with tramadol for pain after surgery to remove their tonsils and/or adenoids. FDA is evaluating all available information and will communicate final conclusions and recommendations to the public when the review is complete.
  • September 22, 2015Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors: FDA is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.

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