The FDA has issued new warnings about the use of the opioid analgesics codeine and tramadol in children, particularly those <12 years old, and in breastfeeding women due to concerns about the risk of respiratory depression and death. The FDA previously issued warnings about these drugs in 2013 and 2015.

View the Table: GLP-1 and GIP/GLP-1 Receptor Agonists for Chronic Weight Management

The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray formulations, Narcan and one of its generics, were approved for OTC sale in 2023.

The FDA has approved use of gamma hydroxybutyrate (sodium oxybate is the official generic name; Xyrem - Orphan Medical) for oral treatment of cataplexy in patients with narcolepsy. Gamma hydroxybutyrate (GHB), a metabolite of gamma-aminobutyric acid (GABA), is a central-nervous-system depressant marketed in Europe for use in general anesthesia. In recent years it has been notorious for its use in "date-rape" (Medical Letter 2002; 44:21). Xyrem is a Schedule III controlled substance.

Gamma hydroxybutyrate (GHB), a central-nervous-system depressant notorious for its use in "date rape", was approved by the FDA in 2002 as sodium oxybate (Xyrem - Jazz Pharmaceuticals) for oral treatment of cataplexy in patients with narcolepsy. Now it has also been approved for treatment of excessive daytime sleepiness (EDS) in these patients. Xyrem is a Schedule III controlled substance.

View the Table: GLP-1 and GIP/GLP-1 Receptor Agonists for Type 2 Diabetes

The FDA has approved Azmiro (Azurity), the first injectable formulation of testosterone cypionate to become available in single-dose vials and prefilled syringes for treatment of males with conditions associated with a deficiency or absence of endogenous testosterone. Injectable testosterone cypionate has been available in multidose vials (Depo-Testosterone, and generics) for many years. Testosterone enanthate (Xyosted) is available in prefilled autoinjectors for use in adult men. No testosterone products are approved for treatment of low testosterone levels due solely to aging. All...

The FDA has approved an auto-injector formulation of testosterone enanthate (Xyosted – Antares Pharma) for once-weekly subcutaneous self-administration in adult males with conditions associated with a deficiency or absence of endogenous testosterone. It is the first subcutaneous formulation of testosterone to be approved by the FDA. Xyosted is contraindicated for treatment of low testosterone levels associated with aging.

The FDA has approved suvorexant (Belsomra – Merck), the first orexin receptor antagonist to become available in the US, for treatment of sleep-onset and/or sleep-maintenance insomnia.

The FDA has approved a higher-dose intranasal naloxone formulation (Kloxxado – Hikma) for emergency treatment of opioid overdose. A single spray of the new formulation delivers 8 mg of naloxone; a formulation that delivers 4 mg per spray (Narcan) was approved in 2015.