The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS) within 42 days of administration of either vaccine. Both vaccines are FDA-approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults.Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants from birth through 6 months of age.

View the Comparison Chart: Some Drugs for Abdominal Pain in Irritable Bowel Syndrome (IBS)

The FDA has approved Toujeo (Sanofi), a more concentrated form of insulin glargine containing 300 IU/mL compared to the 100 IU/mL in Lantus (Sanofi). Lantus is nearing the end of its patent protection in the US, and biosimilars are expected to become available.

The FDA has approved Cabenuva (ViiV Healthcare), an extended-release formulation of the new integrase strand transfer inhibitor (INSTI) cabotegravir copackaged with an extended-release formulation of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine, as a once-monthly complete regimen for intramuscular (IM) treatment of adults with HIV-1 infection who are virologically suppressed (HIV-1 RNA...

The FDA has approved Mavyret (Abbvie) and Vosevi (Gilead), two new fixed-dose combinations of direct-acting antiviral (DAA) drugs, for treatment of chronic hepatitis C virus (HCV) infection caused by any of the six major HCV genotypes in patients without cirrhosis or with compensated cirrhosis. Both are approved for use in treatment-experienced patients. Mavyret is also approved for treatment-naive patients.

Bacterial infections in adults are generally treated empirically, with the antibiotic covering most, but not all, of the potential causative pathogens. For some infections, culture and sensitivity testing can guide treatment, allowing for use of narrower-spectrum antibiotics. The recommended dosages and durations of antibiotic treatment for common respiratory, skin, and urinary tract infections are listed in Tables 1-3. Infectious disease experts now recommend shorter treatment durations for many infections to reduce the development of antimicrobial resistance and minimize adverse...

Ondansetron (on dan' se tron; Zofran - Glaxo), a serotonin (5-hydroxytryptamine) antagonist, was recently marketed in the USA for intravenous use to prevent nausea and vomiting due to cancer chemotherapy. An oral formulation is available in many other countries.

Zileuton (zye loo' ton; Zyflo - Abbott), an inhibitor of leukotriene synthesis, has been approved by the US Food and Drug Administration (FDA) for prophylaxis and maintenance treatment of chronic asthma in adults and children more than 12 years old. A related drug—zafirlukast (Accolate), a leukotriene receptor antagonist—was recently reviewed in the Medical Letter (vol. 38, page 111, December 20, 1996). Neither of these drugs is recommended for treatment of acute asthma.

Rasburicase (Elitek - Sanofi-Synthelabo), a recombinant form of urate oxidase derived from the fungus Aspergillus flavus, has been approved by the FDA for intravenous (IV) management of hyperuricemia associated with tumor lysis syndrome in pediatric patients.

The FDA has approved deferiprone (de fer’ i prone; Ferriprox – ApoPharma), an oral chelating agent available in Europe since 1999, for use as a second-line treatment of iron overload due to blood transfusions (transfusional hemosiderosis) in patients with thalassemia. Two other iron chelating agents, deferoxamine (Desferal, and others), which is usually administered subcutaneously, and oral deferasirox (Exjade), are available for use as first-line therapy in the US.