The FDA has licensed PreHevbrio (VBI Vaccines), a recombinant, 3-antigen, 3-dose hepatitis B vaccine, for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults. It has been available in Israel since 2000.

The FDA has approved miltefosine (Impavido – Knight Therapeutics), an oral alkylphosphocholine analog, for treatment of visceral, cutaneous, and mucosal leishmaniasis caused by some Leishmania species. It is the first drug to be approved by the FDA for treatment of cutaneous and mucosal leishmaniasis and the first oral drug to be approved for treatment of visceral leishmaniasis.

Cytomegalovirus immune globulin (CMVIG) for intravenous administration is now available in the USA on an investigational basis (FE Young and SL Nightingale, JAMA, 260:224, July 8, 1988) for prevention of cytomegalovirus (CMV) infection in CMV-seronegative renal transplant recipients who receive a kidney from a seropositive donor. CMVIG contains IgG antibodies from a pool of healthy donors with high titers of antibodies against CMV. The drug can be obtained from the Massachusetts Department of Public Health Biologic Laboratories (617-522-3700, extension 264) or the American Red Cross...

The 2017 adult immunization schedule approved by the CDC's Advisory Committee on Immunization Practices (ACIP) includes some new or revised recommendations.1 The complete schedule is available on the CDC's website (www.cdc.gov/vaccines/schedule). New recommendations for use of influenza vaccine during the 2016-2017 season were included in a previous issue of The Medical Letter.2 Updated recommendations for other vaccines are summarized below. Recommendations for routine use of vaccines in adults were reviewed in an earlier issue.3DK Kim et al. Advisory Committee on Immunization Practices...

The FDA has required changes in the labeling of all systemic fluoroquinolone antibiotics to strengthen warnings about the risk of severe hypoglycemia and mental health effects associated with their use.1An FDA review identified 67 cases of hypoglycemic coma associated with fluoroquinolone use, 22 of which resulted in death or disability. Most cases occurred in patients with risk factors such as diabetes (especially those taking a sulfonylurea), older age, or renal insufficiency.1 In observational studies in older adults and patients with diabetes, fluoroquinolones have been associated with...

The EarCheck Middle Ear Monitor (Innovia Medical) is a device marketed to consumers for home detection of middle-ear effusion (MEE) in children.

Inhaled antibiotics, which can achieve high concentrations in the lung with minimal systemic side effects, are probably the most effective therapy available for chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis. An orally inhaled dry powder formulation of the aminoglycoside antibiotic tobramycin (Tobi Podhaler – Novartis) has been approved by the FDA for management of P. aeruginosa pulmonary infection in cystic fibrosis patients ≥6 years old. The new formulation is administered via a hand-held pocket-sized inhaler. Tobramycin is also available as an...

Ceftibuten (Cedax - Schering), an oral cephalosporin similar to cefixime (Suprax - Medical Letter, 31:73, 1989), has been approved by the US Food and Drug Administration (FDA) for treatment of acute otitis media, pharyngitis or tonsillitis, and for acute bacterial exacerbations of chronic bronchitis.

Palivizumab (Synagis - MedImmune), an injectable monoclonal antibody, has been marketed in the USA since 1999 for prevention of respiratory syncytial virus (RSV) disease in high-risk infants and children.

The FDA has approved ocrelizumab (Ocrevus – Genentech), a humanized anti-CD20 monoclonal antibody, for treatment of adults with primary progressive or relapsing multiple sclerosis (MS). It is the first anti-CD20 monoclonal antibody to be approved for treatment of MS and the first disease-modifying drug to be approved in the US for primary progressive MS.