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.

The FDA has approved Dovato (ViiV), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) dolutegravir (Tivicay) and the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (Epivir, and generics), as a once-daily complete regimen for treatment of adults with HIV-1 infection who are antiretroviral-treatment naive and have no known substitutions associated with resistance to either drug. Dolutegravir/lamivudine is the first complete regimen to be approved by the FDA for initial treatment of HIV-1 infection that contains 2 rather than 3 antiretroviral...

The FDA has approved two new drugs for sickle cell disease: crizanlizumab-tmca (Adakveo – Novartis), an IV P-selectin blocker, and voxelotor (Oxbryta – GBT), an oral hemoglobin S (HbS) polymerization inhibitor.

The FDA has approved the oral second-generation antipsychotic drug brexpiprazole (Rexulti – Otsuka/Lundbeck) for once-daily treatment of agitation associated with dementia due to Alzheimer's disease (AD). Brexpiprazole is the first drug to be approved in the US for this indication. It is also approved for treatment of schizophrenia and as an adjunct to antidepressants for treatment of major depressive disorder.

Tramadol (Ultram, and others) and gabapentin (Neurontin, and others) are increasingly being prescribed for treatment of chronic pain despite reports of serious adverse events associated with their use. Both drugs are touted as safer and less addictive than strong opioids, but supporting evidence is lacking.

Smoking tobacco remains the primary preventable cause of death in the US. Smoking cessation often requires both pharmacotherapy and behavioral support.

Anticoagulants are the drugs of choice for treatment and prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE), collectively referred to as venous thromboembolism (VTE). US guidelines for treatment of VTE were updated in 2020 and 2021.

Vorinostat (Zolinza - Merck), an oral histone deacetylase (HDAC) inhibitor, has received accelerated approval from the FDA for treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) that is persistent, progressive or recurrent after two systemic therapies. The most common types of CTCL are mycosis fungoides and SΘzary syndrome, the leukemic form of mycosis fungoides.

Bepotastine besilate 1.5% ophthalmic solution (Bepreve - ISTA Pharmaceuticals), an H₁-antihistamine, has been approved by the FDA for topical treatment of itching associated with allergic conjunctivitis in patients ≥2 years old. Bepotastine was first developed in an oral systemic formulation and has been used as such for treatment of allergic rhinitis in Japan.

The FDA has approved ezogabine (ee-ZOE-ga-been; Potiga – GSK/Valeant) for oral adjunctive treatment of partial-onset seizures in adults. Ezogabine is available in Europe as retigabine (Trobalt).