New opioid warnings, powdered glove ban

The FDA announced plans to add new warnings to opioids and to ban powdered medical gloves last week.

Immediate-release opioids will carry a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death. The updated labeling will also clarify that the drugs should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., nonopioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated, as well as providing dosing information with clearer instructions regarding patient monitoring and drug administration, according to an FDA news release.

The entire class of opioids will also carry new warnings about the risks of serotonin syndrome when combined with antidepressants and migraine medicines, the rare but serious side effect of adrenal insufficiency, and the possibility of decreased sex hormone levels. Details on these risks were provided in a drug safety alert.

Finally, the agency announced a proposed ban on powdered surgeons' gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeons' gloves, because these products pose an unreasonable and substantial risk of illness or injury to clinicians, patients, and other individuals who are exposed to them, according to a news release. The risks include respiratory allergic reactions with powdered latex gloves and severe airway inflammation, wound inflammation, and postsurgical adhesions with powdered synthetic gloves, the FDA said. The proposal is open for comment for 90 days.