The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.

The FDA has approved a rapidly disintegrating tablet formulation of the antiepileptic drug levetiracetam (Spritam – Aprecia) for adjunctive treatment of partialonset, myoclonic, and primary generalized tonicclonic seizures. Oral and intravenous formulations of levetiracetam (Keppra, and generics) have been available for years. Although approved by the FDA only as adjunctive therapy, levetiracetam is commonly used as monotherapy for partial-onset and generalized seizures and may also be effective in treating absence seizures and seizures of Lennox-Gastaut syndrome.

The FDA has approved subdermal implants of the partial opioid agonist buprenorphine (Probuphine – Titan) for maintenance treatment of opioid dependence in patients stabilized on low to moderate doses of transmucosal buprenorphine. Probuphine was designed to provide continuous low levels of buprenorphine for 6 months and to safeguard against illicit use of the drug.

Interim results of a double-blind, placebo-controlled trial suggest that off-label use of the anticholinergic drug oxybutynin may reduce the frequency and severity of hot flashes in women with breast cancer. Extended-release oral oxybutynin (Ditropan XL, and generics) has been shown to reduce the frequency and severity of hot flashes in healthy menopausal women.

The antisense oligonucleotide viltolarsen (Viltepso – NS Pharma) has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 53 skipping (DMD-53). It is the second drug to be approved for this indication; the antisense oligonucleotide golodirsen (Vyondys 53) was approved in 2019.

Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.

Penpulimab-kcqx (Anniko – Akeso Biopharma), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin or carboplatin plus gemcitabine for first-line treatment of recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma and for use as monotherapy for metastatic disease in adults with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Penpulimab is the second immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma;...

Acute toxic reactions to drugs of abuse continue to be important problems. Some patients may have mixed intoxications with complex combinations of signs and symptoms.

Oral antipsychotic drugs used for treatment of schizophrenia, schizoaffective disorder, delusional disorder, and other manifestations of psychosis or mania are listed in Table 1. Parenteral antipsychotic drugs used for treatment of these disorders are listed in Table 2.

Fluoxetine (Prozac - Dista), a phenylpropylamide, is the first serotonin-reuptake blocker introduced in the USA for treatment of . It is being promoted as causing fewer adverse effects than other antidepressants. Claims of greater safety and patient tolerability have often been made for new non-tricyclic antidepressants in recent years, but unpredicted adverse effects have emerged with widespread use, including priapism with trazodone (Desyrel - Medical Letter, 26:35, 1984) and fatal hemolytic anemia with nomifensine (Merital - Medical Letter, 27:73, 1985).