The FDA has approved the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin (Nesina – Takeda) for treatment of type 2 diabetes. In addition to the single-ingredient product, the FDA also approved fixed-dose combinations of alogliptin/metformin (Kazano) and alogliptin/pioglitazone (Oseni) for the same indication. Alogliptin is the fourth DPP-4 inhibitor to become available in the US. The other three – saxagliptin (Onglyza), sitagliptin (Januvia), and linagliptin (Tradjenta) – are also available in fixed-dose combinations with metformin.

Etidronate (e ti droe' nate) disodium (Didronel - Norwich Eaton), an oral bisphosphonate available for many years for treatment of Paget's disease (Medical Letter, 20:78, 1978), recently has also been used for treatment of postmenopausal osteoporosis.

Terazosin (Hytrin - Abbott), a postsynaptic alpha 1 -adrenoreceptor blocker previ-ously available for treatment of hypertension (Medical Letter, 29:113, 1987), has now been approved by the US Food and Drug Administration (FDA) for treatment of benign prostatic hyperplasia (BPH). Although not previously approved by the FDA, terazosin and other alpha-blockers such as prazosin (Minipress, and others) or doxazosin (Car-dura) have been used for this indication for many years.

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...

Imiquimod (i mi kwi' mod) 5% cream (Aldara - 3M Pharmaceuticals) has been approved by the FDA for treatment of external genital and perianal warts (condyloma acuminata). The drug requires a prescription but is applied by the patient. It is the second patient-applied treatment to become available for external genital warts; the first was podofilox (Condylox - Medical Letter, 33:117, 1991).

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 FDA has approved ruxolitinib (Jakafi – Incyte), a janus-associated kinase (JAK) inhibitor, for treatment of myelofibrosis. Jakafi is the first JAK inhibitor to be approved for any indication and the only drug approved for treatment of myelofibrosis.

The FDA has approved telotristat ethyl (Xermelo – Lexicon), a tryptophan hydroxylase inhibitor, for use in combination with a somatostatin analog (SSA) for treatment of carcinoid syndrome diarrhea inadequately controlled with SSA therapy alone. Telotristat ethyl is the first oral drug to be approved in the US for this indication.

Rilonacept (Arcalyst – Kiniksa), an interleukin-1 (IL-1) antagonist that has been available for years for treatment of cryopyrin-associated periodic syndromes, has now been approved by the FDA for treatment of recurrent pericarditis and prevention of further recurrences in patients ≥12 years old. It is the first drug to be approved in the US for this indication. Anakinra (Kineret), an IL-1 receptor antagonist FDA-approved for treatment of rheumatoid arthritis, has been used off-label for years for treatment of recurrent pericarditis.

Valoctocogene roxaparvovec-rvox (Roctavian – Biomarin), an adeno-associated virus (AAV) vector-based gene therapy, has been approved by the FDA for one-time treatment of severe hemophilia A in adults without pre-existing antibodies to AAV serotype 5. It is the first gene therapy to be approved in the US for treatment of hemophilia A.