The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) and the adenovirus-based vaccine manufactured by Johnson & Johnson/Janssen to include administration of a booster dose in select populations after primary immunization with either the same COVID-19 vaccine or a different one.

The American Congress of Obstetricians and Gynecologists (ACOG) has announced a new recommendation for antibiotic prophylaxis during cesarean delivery.1 Currently most women receive a single dose of prophylactic antibiotics after the umbilical cord has been clamped to prevent antibiotics from crossing over to the newborn. The new recommendation is for women giving birth by cesarean section to routinely receive antibiotics within one hour before the start of surgery. In the case of an emergency cesarean delivery, prophylaxis should be started as soon as possible.Recent studies have found a...

An outbreak of mumps has occurred among students at Fordham University in New York. All of those who developed mumps had been vaccinated against the disease.

The FDA has approved an IV formulation of the antifungal drug posaconazole (Noxafil - Merck) for prophylaxis of Aspergillus and Candida infections in adults at high risk for these infections, such as those with prolonged neutropenia. Posaconazole is also available as delayed-release tablets and an oral suspension.With activity against Aspergillus and Candida, posaconazole has an antifungal spectrum similar to that of voriconazole (Vfend, and generics), but unlike voriconazole it is also active against many species of Mucorales (formerly called Zygomycetes), such as Mucor and Rhizopus....

Atovaquone (Mepron - Burroughs Wellcome), a hydroxynaphthoquinone, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who cannot tolerate trimethoprim-sulfamethoxazole (Septra, Bactrim, and others). PCP is a common opportunistic infection and frequent cause of death in patients with AIDS.

Recombinant human deoxyribonuclease I (rhDNase; dornase alfa; Pulmozyme - Genentech), an enzyme that hydrolyzes extracellular DNA, is now available as a purified solution to decrease the viscosity of sputum in patients with cystic fibrosis. It requires a nebulizer to produce an aerosol mist for inhalation.

(Med Lett Drugs Ther 2009; 51:25) In the paragraph on dosing, the second-to-last sentence should have said that the new recommendations suggest considering use of an alternative antibiotic when the MIC for the infecting organism is ≥2 mg/L, not >2 mg/L.

Rilonacept (Arcalyst – Kiniksa), an interleukin-1 (IL-1) antagonist that has been available for years for treatment of cryopyrin-associated periodic syndromes, has now been approved by the FDA for treatment of recurrent pericarditis and prevention of further recurrences in patients ≥12 years old. It is the first drug to be approved in the US for this indication. Anakinra (Kineret), an IL-1 receptor antagonist FDA-approved for treatment of rheumatoid arthritis, has been used off-label for years for treatment of recurrent pericarditis.

Axatilimab-csfr (Niktimvo – Incyte), a colony stimulating factor-1 receptor-blocking antibody, has been approved by the FDA for intravenous treatment of chronic graft-versus-host disease (cGVHD) after failure of at least 2 lines of systemic therapy in patients weighing ≥40 kg. Corticosteroids are generally the first-line treatment for cGVHD. The oral kinase inhibitors ibrutinib (Imbruvica), ruxolitinib (Jakafi), and belumosudil (Rezurock) are also approved for treatment of cGVHD. Extracorporeal photopheresis has been used off-label.

Recombinant interferon alfa-2b conjugated to polyethylene glycol (PEG-Intron), the first "pegylated"alpha interferon, has been approved by the FDA for once-a-week monotherapy of chronic hepatitis C virus (HCV) infection in patients not previously treated with alpha interferon.