Warfarin-related bleeding, especially intracranial hemorrhage, can be catastrophic. Several products are available to reverse warfarin’s anticoagulant effect.

The FDA has approved ferric carboxymaltose (Injectafer – American Regent), a 2-dose intravenous iron replacement product, for treatment of iron deficiency anemia (IDA) in adults who cannot tolerate or have had an unsatisfactory response to oral iron and in those who have non-dialysis-dependent chronic kidney disease (CKD). It is the sixth IV iron product approved in the US.

An injectable foam formulation of the sclerosing agent polidocanol (Varithena – Provensis/BTG) has been approved by the FDA for treatment of incompetent veins and visible varicosities of the great saphenous vein system. It is the first foam therapy to be approved for this indication, but polidocanol and other sclerosants have been used for years as foam formulations compounded by physicians. Polidocanol is also available in a liquid formulation (Asclera) to treat smaller veins. Sodium tetradecyl sulfate (Sotradecol) is FDA-approved in a liquid formulation for use in...

The FDA has approved Bexsero (Novartis/GSK), a vaccine that protects against invasive meningococcal disease caused by Neisseria meningitidis serogroup B. It is the second serogroup B meningococcal vaccine to be approved in the US; Trumenba was the first. Both vaccines are approved for use in persons 10-25 years old. Bexsero is approved in Europe, Canada, and Australia for use in children as young as 2 months old.

The investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV – Regeneron) have been available in the US under an Emergency Use Authorization (EUA) since late 2020 for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons, if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response...

View Expanded Table: Some Conventional DMARDs for Rheumatoid Arthritis

Epsolay (Galderma), a 5% benzoyl peroxide cream, has been approved by the FDA for treatment of inflammatory lesions of rosacea in adults. It is the first product containing benzoyl peroxide to be approved in the US for treatment of rosacea. Benzoyl peroxide formulations approved for acne have been used off-label to treat rosacea for years, but itching and burning have limited their use.

Anistreplase (Eminase - SmithKline Beecham, Upjohn), a plasminogen activator also known as APSAC, was recently approved by the US Food and Drug Administration (FDA) for intravenous (IV) thrombolytic treatment of coronary thrombosis. Three other thrombolytic agents - intracoronary urokinase (Abbokinase) and intracoronary or intravenous streptokinase (Streptase; Kabikinase) and alteplase (TPA; Activase)- were previously approved for coronary thrombolysis (Medical Letter, 29:107, 1987).

Loracarbef (Lorabid - Lilly), a new beta-lactam antibiotic with antimicrobial activity similar to the second-generation cephalosporins, has been approved by the US Food and Drug Administration for treatment of respiratory, skin, and urinary tract infection caused by susceptible organisms in both adults and children. It will probably compete with drugs such as trimethoprim-sulfamethoxazole (Bactrim, Septra, and others), amoxicillin-clavulanic acid (Augmentin), cefaclor (Ceclor), cefuroxime axetil (Ceftin), and cefprozil (Cefzil - Medical Letter, 34:63,...

Many drugs, mostly azole derivatives, are marketed in the USA for topical treatment of vulvovaginal candidiasis. A single-dose, sustained-release formulation of butoconazole nitrate 2% cream (Gynazole 1) is the newest addition. Fluconazole (Diflucan) is approved for single-dose oral treatment.