The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

Nemolizumab (Nemluvio – Galderma), a subcutaneously injected interleukin-31 (IL-31) receptor antagonist, has been approved by the FDA for use in combination with topical corticosteroids and/or calcineurin inhibitors for treatment of moderate to severe atopic dermatitis in patients ≥12 years old whose disease is not adequately controlled with topical prescription drugs. It is the first IL-31 receptor antagonist to be approved in the US for this indication. Nemolizumab was approved earlier for treatment of prurigo nodularis in adults.

Trimetrexate glucuronate (Parke-Davis), an investigational drug, is now available in the USA from the National Institute of Allergy and Infectious Diseases (NIAID) for treatment of selected AIDS patients with Pneumocystis carinii pneumonia (PCP). For this indication, trimetrexate is always used concurrently with leucovorin (Wellcovorin; and others).

Fludarabine phosphate (Fludara - Berlex), an analog of vidarabine (Vira-A), was recently approved by the U.S. Food and Drug Administration for treatment of patients with refractory chronic lymphocytic leukemia (CLL). The drug has not yet been marketed but is still available, as it has been for two years, through the National Cancer Institute.

Thalidomide is now available as an investigational drug in the USA. A synthetic derivative of glutamic acid, it was marketed in Europe in 1957 as a sedative but withdrawn four years later after being associated with severe human teratogenicity (PF DArcy and JP Griffin, Adverse Drug React Toxicol Rev, 13:65, 1994). The drug has since been found effective for several different indications.

Recent articles in the press have suggested that in early pregnancy, an intramuscular (IM) injection of methotrexate (Folex, and others), a folic acid antagonist, and oral or vaginal administration of misoprostol (Cytotec), a prostaglandin, offers a medical alternative to a surgically induced abortion. Methotrexate is approved by the US Food and Drug Administration for use in rheumatoid arthritis, psoriasis and various types of cancer, including choriocarcinoma, and has also been used to terminate ectopic pregnancies. Misoprostol is approved for prevention of gastric ulcers induced by...

The FDA recently advised health care professionals and consumers not to use a number of dietary supplements found to contain the phosphodiesterase-5 inhibitor sildenafil (Viagra) or an analog of the drug (www.fda.gov). Although the effects of sildenafil may be noticeable (in men), the presence of other, possibly more toxic adulterants in dietary supplements may be more difficult or impossible to detect.Other drugs previously found in dietary supplements have included lovastatin (Mevacor, and others), estrogen, alprazolam (Xanax, and others), indomethacin (Indocin, and others) and warfarin...

The Medical Letter was founded in 1959 by Arthur Kallet, an engineer, and Dr. Harold Aaron, an internist. In 1932, Kallet had written the book 100,000,000 Guinea Pigs, a best-seller that was partly responsible for the Food and Drug Act of 1938, which required for the first time that new drugs show proof of safety. He was the founding director of Consumers Union and started the publication of Consumer Reports. Dr. Aaron, who became the medical director of Consumer Reports, suggested to Kallet that doctors could use a similar publication to evaluate the new drugs that were coming on the market...

Many patients with hypertension require more than one drug to control their blood pressure. Tribenzor (Daiichi Sankyo), recently approved by the FDA for treatment of hypertension, combines the calcium channel blocker amlodipine (Norvasc, and others), the angiotensin receptor blocker (ARB) olmesartan (Benicar)and the most commonly prescribed diuretic, hydrochlorothiazide (HCTZ). Tribenzor is not approved for initial therapy, but is recommended for patients not adequately controlled on any 2-drug combination of a calcium channel blocker, an ARB or a diuretic.

The FDA recently approved vandetanib [van det´ a nib] (Caprelsa – AstraZeneca) for oral treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Vandetanib is the first drug approved in the US for medullary thyroid cancer.