View the Comparison Table: Some Nonopioid Analgesics for Pain

The FDA has required the addition of information about an increased risk of nonmelanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) to the labels of products containing the diuretic hydrochlorothiazide.

On April 13, 2021, the FDA and CDC advised suspending use of the Johnson & Johnson adenovirus-based COVID-19 vaccine while the agencies investigate 6 cases of cerebral venous sinus thrombosis (CVST) and thrombocytopenia that occurred following administration of the vaccine. In an April 14 emergency meeting, the Advisory Committee on Immunization Practices (ACIP) recommended continuing the suspension until more data become available. About 7 million people in the US have received the Johnson & Johnson vaccine.

View the Treatment of COVID-19 in High-Risk Outpatients Chart

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 the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

The FDA has approved two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to conditions such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Jatenzo, another oral testosterone undecanoate formulation, was approved for the same indication in 2019. No testosterone products are approved for treatment of low testosterone levels due solely to...

The FDA has approved an extended-release fixed-dose combination of dextromethorphan and bupropion (Auvelity – Axsome) for treatment of major depressive disorder (MDD) in adults.

Azelastine hydrochloride, a histamine-H1 receptor antagonist, has been marketed as a 0.1% nasal spray (Astelin - Wallace) for treatment of seasonal allergic rhinitis. Corticosteroid and cromolyn sodium nasal sprays are also available for this indication (Medical Letter, 37:5, 1995). Cromolyn sodium (Nasalcrom) has now been approved for over-the-counter use.

The FDA has approved the use of the 5α-reductase inhibitor dutasteride (Avodart - GlaxoSmithKline) together with the alpha₁-blocker tamsulosin (Flomax - Boehringer Ingelheim) for treatment of benign prostatic hyperplasia (BPH). Use of an alpha1-blocker with a 5α-reductase inhibitor has been a common practice for years, but FDA approval of a particular combination permits the manufacturers to add an indication for it in both package inserts, recommend dosage for combination use, and advertise the benefits of using the 2 drugs together.