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Top news of the day from across the health care landscape.
The CDC has clarified its 2015 opioid prescribing guideline, indicating that it was not intended to deny therapy to patients with acute or chronic pain caused by cancer or sickle-cell disease, The Philadelphia Inquirer reported. According to the article, although the agency’s guideline stated that its recommendations do not apply to patients undergoing active cancer and sickle-cell disease treatment, some patients with these diseases have difficulty gaining access to painkillers. Clifford Hudis, chief executive officer of the American Society of Clinical Oncology, said in a statement that many payers have been inappropriately using the guidelines to make coverage determinations for those populations, the article reported.
Officials with the FDA refused to fully review the marketing application for Zogenix Inc’s treatment for seizures associated with Dravet syndrome, Reuters reported. According to the article, the drug, to be branded as Fintepla, uses a low-dose, liquid solution of fenfluramine, which was used in an obesity drug combination that was withdrawn from the market due to evidence of heart valve damage. After a preliminary review, the FDA cited a lack of certain non-clinical studies to assess the chronic administration of fenfluramine and due to an incorrect dataset, the article reported.
The FDA is warning physicians not to abruptly stop prescribing opioid painkillers to patients taking them for chronic pain ailments, The Associated Press reported. According to the article, the agency announced it will add advice to labels on how to taper opioid painkillers. The new label will warn physicians that rapidly discontinuing opioids in patients who are dependent on them can cause withdrawal symptoms, the article reported.
FDA Approves Bimekizumab-Bkzx as Treatment for Hidradenitis Suppurativa