Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), has been approved by the FDA for treatment of major depressive disorder in adults, and more recently for diabetic peripheral neuropathy as well. The Medical Letter will review its role in diabetic neuropathy in a future issue.

An FDA panel has recommended that stronger warnings about hepatotoxicity be added to the labeling for acetaminophen (www.fda.gov, search "acetaminophen hepatotoxicity").

Concerns have surfaced again at the FDA and in the media about the safety of acetaminophen and the multiplicity of products on the market in the US that contain various amounts of it.

Many commonly used drugs can interfere with sexual function in both men and women, causing loss of libido, interfering with erection or ejaculation in men, and delaying or preventing orgasm in women. Drug-related effects on sexual function may be difficult to distinguish from the effects of depression or disease, but most are reversible when drug use is stopped and sometimes when dosage is decreased. Since many patients are reluctant to talk about sexual difficulties, physicians may wish to ask about the possibility of drug-induced sexual dysfunction, particularly when they have...

Almotriptan (Axert - Pharmacia), and Frovatriptan (Frova - Elan) have been approved by the FDA for oral treatment of migraine headache (Drugs of Choice from The Medical Letter 2001, page 131.).

Berotralstat (Orladeyo – Biocryst), an oral plasma kallikrein inhibitor, has been approved by the FDA for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. The subcutaneously-injected plasma kallikrein inhibitor lanadelumab-flyo (Takhzyro) and the human plasma-derived C1 esterase inhibitors (C1INHs) Cinryze, which is given IV, and Haegarda, which is given SC, have been available for prophylaxis of HAE for years.

Betibeglogene autotemcel (Zynteglo — Bluebird Bio), an autologous lentiviral vector cell-based gene therapy, has been approved by the FDA for one-time treatment of transfusion-dependent beta thalassemia in children and adults. Exagamglogene autotemcel (Casgevy), a cell-based gene therapy that uses CRISPR/Cas9 gene-editing technology, was approved earlier this year for the same indication in patients ≥12 years old.

The FDA has approved imetelstat (Rytelo – Geron), a first-in-class telomerase inhibitor, for treatment of low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with transfusion-dependent anemia requiring 4 or more red blood cell (RBC) units over 8 weeks who have not responded to, are no longer responding to, or are ineligible for erythropoiesis-stimulating agents (ESAs).

View the Comparison Table: Triptans for Migraine