An outbreak (8 cases to date) of meningococcal disease at Princeton University caused by Neisseria meningitidis serogroup B has led the FDA and CDC to permit importation and investigational use (at Princeton University only) of a meningococcus B vaccine (4CMenB; Bexsero – Novartis) that has not been approved in the US. Bexsero has been approved for use in the European Union and in Australia.THE VACCINE — Until recently, no serogroup B vaccine was widely available because the polysaccharide capsule of the B serogroup, unlike those of the other main meningococcal serogroups (A, C, Y, and...

The FDA has approved Lonsurf (Taiho Oncology), a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil, for oral treatment of metastatic colorectal cancer. Trifluridine is incorporated into DNA, interfering with DNA synthesis and inhibiting cell proliferation. Tipiracil inhibits the metabolism of trifluridine. The combination is only approved for use in patients who were previously treated with a fluoropyrimidine (fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF biological such as bevacizumab, and, if the tumor...

The FDA has approved an oral suspension formulation of nitisinone (Orfadin – Sobi) for treatment of hereditary tyrosinemia type 1 (HT-1). Orfadin has been available in a capsule formulation in Canada since 1994 and in the US since 2002.HT-1 is an autosomal recessive genetic disorder (estimated birth prevalence: 1:100,000) caused by mutations in the gene responsible for formation of fumarylacetoacetate hydrolase (FAH), which catalyzes the last step in tyrosine metabolism. FAH deficiency results in accumulation of upstream toxic metabolites, causing liver and kidney failure and developmental...

Patients may ask about taking elderberry for prevention and treatment of influenza. Products containing elderberry are promoted for relief of cold and flu symptoms and as an immune system booster.

The FDA has approved two additional doses (3 mg and 4.5 mg) of the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide (Trulicity – Lilly) for treatment of type 2 diabetes in adults. Dulaglutide has been available in 0.75- and 1.5-mg doses for years.

As cocaine continues to be widely available in the USA (Medical Letter, 28:69, 1986), new problems associated with its use continue to emerge. Some recent reports indicate that use of the drug during pregnancy can damage the fetus, lead to abortion or premature labor, and cause toxic effects in the newborn infant.

Estazolam (ProSom - Abbott), a triazolobenzodiazepine derivative similar in structure to alprazolam (Xanax) and triazolam (Halcion), was recently marketed in the USA for treatment of insomnia.

In 1989, Photoplex (Allergan Herbert), a combination of the dibenzoyl methane avobenzone (Parsol 1789) and the aminobenzoic acid (PABA) ester padimate O, was the first 'broad spectrum' sunscreen to become available in the USA (Medical Letter, 31:59, 1989). Now, Shade UVAGuard (Schering-Plough), a similar product, has been approved by the US Food and Drug Administration; it also contains avobenzone, plus the benzophenone oxybenzone and octyl methoxycinnamate.

The Medical Letter has received many inquiries about use of glucosamine, a basic constituent of articular cartilage glycosaminoglycans, for treatment of arthritis. A recently published book (The Arthritis Cure), several television news shows, and articles in The New York Times have suggested it may be effective for treatment of osteoarthritis. Glucosamine is sold as a 'dietary supplement' in the USA.

The FDA has approved incobotulinumtoxinA (Xeomin – Merz) for treatment of cervical dystonia and blepharospasm in adults. It has been commercially available in Germany since 2005. Several formulations of botulinum toxin type A (Botox; Dysport) and type B (Myobloc) are already marketed for treatment of cervical dystonia. Botox is also approved for treatment of blepharospasm.