NGC Update Service: September 28, 2015 ► U.S. Food and Drug Administration (FDA) Advisories

NGC Update Service: September 28, 2015

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

• September 15, 2015: Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program: FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. Severe neutropenia is a dangerously low number of neutrophils, white blood cells that help fight infections. Severe neutropenia can be life-threatening.
• September 21, 2015: Tramadol: 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.