The FDA has strengthened its warning regarding the combination of opioids and benzodiazepines. The FDA has conducted and reviewed studies showing serious side effects with the combination, which can cause extreme sleepiness, respiratory depression, coma, and death. The warning includes all opioids to treat pain and opioid-based cough medication, along with benzodiazepines and other central nervous system depressants. A boxed warning, the FDA’s strongest warning, will be added to the labels of prescription opioid pain and prescription opioid cough medicines, as well as benzodiazepines. The agency recommends that healthcare professionals limit opioid pain medicines with benzodiazepines or other central nervous system depressants to patients for whom alternative treatment options are inadequate. ()
The FDA has approved the first biosimilar to etanercept for multiple inflammatory diseases. Based on the FDA’s new naming convention for biosimilars, the drug is called etanercept-szzs. The drug is approved for the same indications as the reference drug, including rheumatoid arthritis, severe polyarticular juvenile arthritis, psoriatic arthritis (including use in combination with methotrexate), active ankylosing spondylitis, and chronic to severe plaque psoriasis. Approval was based on evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrate etanercept-szzs is biosimilar to etanercept. Although considered biosimilar, it is not an interchangeable product. Etanercept-szzs carries the same boxed warning as etanercept, including risk of serious infections such as tuberculosis, invasive fungal infections, and others. The warning also notes that lymphoma and other malignancies have been reported in children and adolescents treated with tumor necrosis factors blockers, including etanercept. Etanercept-szzs will be marketed as Erelzi. The drug represents the third biosimilar approved in the United States after infliximab-dyyb and filgrastim-sndz.
The FDA has banned 19 specific active ingredients of over-the-counter antiseptic wash products because manufacturers “did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.” The ban included triclosan, mostly used in liquid soaps, and triclocarban, mostly used in bar soaps, including popular brands. The FDA first proposed the rule in 2013, and many companies began removing triclosan, triclocarban, and other listed agents at that time. There has been concern that these agents are no more effective than washing with plain soap and water and potentially led to negative outcomes, including affecting hormones in unborn children and infants and potentially promoting drug-resistant bacteria. The ruling did not affect hand sanitizers and wipes, although the agency is studying the active ingredients ethanol, ethyl alcohol, isopropyl alcohol, and benzalkonium chloride. ()