The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of progression (not defined in the label). Dapagliflozin is the first SGLT2 inhibitor to be approved in the US for treatment of CKD.

Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. The FDA has issued a proposed rule that would require manufacturers to perform additional safety studies for some sunscreen active ingredients and would mandate better UVA protection in sunscreen products. Some sunscreen products containing FDA-approved active ingredients are listed in Table 2.

Cefditoren pivoxil (Spectracef — TAP), a new oral third-generation cephalosporin, has been approved by the FDA for treatment of acute exacerbations of chronic bronchitis, pharyngitis, tonsillitis and uncomplicated skin and soft tissue infections in adults and children 12 or more years old. The drug has been used in Japan for 7 years.

The FDA has approved an extended-release formulation of amoxicillin (Moxatag – MiddleBrook) for once-daily treatment of pharyngitis or tonsillitis caused by Streptococcus pyogenes in adults and children ≥12 years old. Approval was based on an unpublished study that found once-daily treatment with Moxatag 775 mg for 10 days non-inferior to penicillin V 250 mg four times a day for 10 days in eradication of S. pyogenes.For decades, the drug of choice for oral treatment of streptococcal pharyngitis in adolescents and adults has been penicillin V 250 mg taken three or four times a day.1...

Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara – Janssen), a human interleukin-12 and -23 antagonist previously approved for treatment of moderate-to-severe plaque psoriasis, have now been approved by the FDA for treatment of active psoriatic arthritis.

The FDA has approved golimumab (Simponi – Janssen), a fully human monoclonal antibody specific for tumor necrosis factor (TNF) alpha, for induction and maintenance of remission in patients with moderate to severe ulcerative colitis who do not respond to or cannot tolerate other therapies or who require continuous treatment with corticosteroids. Golimumab was approved earlier for treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is the third TNF inhibitor to be approved for use in ulcerative colitis.

Recently updated guidelines from the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA) address the use of corticosteroids as an adjunct to antimicrobials for treatment of community-acquired pneumonia (CAP).

The FDA has licensed the adjuvanted, recombinant varicella zoster virus (VZV) vaccine Shingrix (GSK) for prevention of herpes zoster (shingles) in adults of any age who are or will be at elevated risk because of disease- or therapy-induced immunodeficiency or immunosuppression. Shingrix has been licensed for herpes zoster prevention in adults ≥50 years old since 2017.1 It is the only VZV vaccine currently available in the US; Zostavax, a live-attenuated VZV vaccine, was withdrawn from the market in 2020.

View the Table: Some Drug Interactions with Drugs for IBD

Tipranavir (Aptivus - Boehringer Ingelheim), a new protease inhibitor, has received accelerated approval from the FDA. It must be given with ritonavir (Norvir). The combination is indicated for use with other antiretrovirals to treat HIV infection in highly treatment-experienced adults who have ongoing viral replication or in those with HIV strains known to be resistant to multiple protease inhibitors.