Human alpha1-proteinase inhibitor (Prolastin Cutter), possibly better known as alpha1-antitypsin (ATT), is now available in the USA for replacement therapy in patients with emphysema who have a congential deficiency of the protein.

Pegademase (Adagen - Enzon), bovine adenosine deaminase (ADA) conjugated with polyethylene glycol (PEG), was recently approved by the US Food and Drug Administration as an 'orphan drug' for treatment of severe combined immunodeficiency disease (SCID). SCID due to inherited deficiency of ADA occurs in less than one per million births; until recently, without extraordinary isolation measures, it was usually fatal before the age of two.

Isradipine (DynaCirc - Sandoz), a dihydropyridine calcium-channel blocker chemically related to nicardipine (Cardene) and nifedipine (Procardia, and others), was recently approved by the US Food and Drug Administration for oral treatment of hypertension.

The Medical Letter continues to receive inquiries about the value of edetate disodium (EDTA) chelation therapy for cardiovascular disease. The last Medical Letter article on this subject was published in 1981 (volume 23, page 51). Some authors have estimated that more than 500,000 people receive this form of treatment each year (MT Grier and DG Meyers, Ann Pharmacother, 27:1504, Dec 1993).

Methadone, an opioid agonist that can be taken orally, has been used for maintenance treatment for many years in the USA (DM Novick et al, Drug Alcohol Depend, 33:235, 1993). Last year, the US Food and Drug Administration approved the distribution and use of L-alpha-acetyl-methadol (LAAM; ORLAAM - Bio Development Corporation, McLean, VA), a long-acting congener of methadone. LAAM, like methadone, will be available for this indication only through federal and state-regulated treatment programs.

Ketoconazole (Nizoral - Janssen), an imidazole antifungal drug widely used in a tablet formulation for treatment of systemic fungal infections (Medical Letter 36:16, 1994) and as a topical preparation for fungal skin infections, is also available as a shampoo for treatment of seborrheic dandruff. The shampoo is sold only by prescription.

Dehydroepiandrosterone (DHEA) is an adrenal androgen now being marketed as a "food supplement"in health food stores. DHEA is not approved for any indication by the US Food and Drug Administration (FDA).

The FDA has approved the use of subcutaneous injections of deoxycholic acid (Kybella – Kythera/Allergan) to improve the appearance of moderate to severe convexity or fullness associated with submental fat (double chin) in adults. It is the first drug approved for this indication.

On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly) has been approved by the FDA for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.1It was previously approved for the same indication, but patients were also required to have a Ki-67 score ≥20%. About 70% of all breast cancers are HR-positive and HER2-negative. Ki-67 is a...