Because of concerns about the possibility of bioterrorism involving smallpox, the US government is reinstituting smallpox vaccination (https://www.cdc.gov/smallpox/; www.idsociety.org/bt/toc.htm). Vaccination is currently expected to proceed in three phases: the military and hospital smallpox response teams first, other health care workers, police and firefighters second, and the general public in the third phase. Except for the military, vaccination will be...

A new Haemophilus influenzae type b capsular polysaccharide vaccine conjugated with diphtheria toxoid (ProHIBiT - Connaught) was recently marketed in the USA. It is being promoted as a replacement for older, unconjugated H. influenzae vaccines (b- Capsa I; Hibimune; HibVAX) previously reviewed in The Medical Letter (Volume 27, page 61, 1985).

Serum measurements of prostate specific antigen (PSA) are now being used in the diagnosis and management of prostate cancer. Produced by prostatic epithelium, PSA is a protease involved in liquefaction of the seminal coagulum. Whether this test should be used for routine screening is a matter of controversy; it is currently approved by the US Food and Drug Administration (FDA) only for monitoring after treatment for prostate cancer.

Tacrolimus ointment (Protopic) has been approved by the FDA in 0.03% and 0.1% formulations for treatment of atopic dermatitis. Tacrolimus is used systemically (Prograf) to prevent rejection of organ transplants.

An injectable gel of hyaluronic acid (Restylane) has been approved by the FDA for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Manufactured by Q-Med AB, a Swedish company, it has been used outside the US since 1996.

The FDA has approved mepolizumab (Nucala - GSK), a subcutaneously injected humanized interleukin-5 (IL-5) antagonist monoclonal antibody, for maintenance treatment of severe asthma in patients ≥12 years old who have an eosinophilic phenotype.

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...

Balfaxar (Octapharma), a human plasma-derived four-factor prothrombin complex concentrate (PCC), has been approved by the FDA for rapid reversal of warfarin anticoagulation in adults who require an urgent surgical/invasive procedure. It is the second four-factor PCC to become available in the US; Kcentra, which has been available since 2013, is approved for the same indication and for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. Balfaxar is marketed in Canada and Europe as Octaplex.

Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.

A Medical Letter reader asked about the use of the nutritional supplement 5-hydroxytryptophan (5-HTP) for treatment of depression. It is sold in health food stores, pharmacies and on-line for many indications including depression, mood enhancement, emotional well being, and promotion of normal sleep.5-HTP is the intermediate metabolite in the biosynthesis of serotonin from L-tryptophan.1 Many small studies in the 1970’s and 1980’s found 5-HTP helpful in the treatment of depression, but a Cochrane Review of 108 studies in patients with depression or dysthymia using 5-HTP or L-tryptophan...