martes, 23 de enero de 2018

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

NGC Update Service: January 22, 2018


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

January 11, 2018Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events: FDA is providing information about reports of pneumothorax events associated with feeding tube placement procedures using enteral access systems (EAS). Most reports indicate these pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death. Although pneumothorax is a known rare complication of "blind insertion" of feeding tubes, typically < 0.5%, FDA is alerting clinicians that the use of EAS devices does not eliminate this risk and reminding health care providers of important safety information about these systems.
January 11, 2018Prescription Opioid Cough and Cold Medicines: FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.
January 16, 2018Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions: Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported in the postmarketing setting, some requiring hospitalization. These reactions have occurred during or soon after the infusion of Varubi (rolapitant) injectable emulsion. Most reactions have occurred within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock.

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