Recent FDA announcements affect diabetes care
Tirzepatide received a new indication, liraglutide got a generic version, and insulin syringes were recalled, in FDA news.
The FDA took several actions related to diabetes care.
On Dec. 20, 2024, the agency a approved new indication for tirzepatide (Zepbound) for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. Approval is based on two randomized placebo-controlled studies finding statistically significant and clinically meaningful reduction in events of apnea or hypopnea compared with placebo. Side effects include nausea, diarrhea, and vomiting, among others.
On Dec. 23, 2024, the FDA authorized the first generic version of liraglutide injection (branded as Victoza), 18 mg/3 mL, a glucagon-like peptide-1 receptor agonist indicated to improve glycemic control in adults and pediatric patients ages 10 years and older with type 2 diabetes as an adjunct to diet and exercise. The drug carries a boxed warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. The FDA approved the first generic in this class of medications with the approval of a generic for exenatide (Byetta) in November.
Finally, the agency also alerted clinicians to a class I recall of certain lots of Monoject U-100 1-mL insulin syringe luer-lock with tip cap soft packs by Cardinal Health, due to an incompatibility with needleless IV connectors. Use with a needless connector may increase the risk that the patient may not receive the full dose of insulin.