Isosorbide mononitrate (ISMN; Ismo - Wyeth-Ayerst), an oral nitrate long available in Europe, was recently approved by the US Food and Drug Administration for prophylactic use in patients with chronic stable angina. ISMN is the major active metabolite of isosorbide dinitrate (ISDN; Isordil, and others).

The FDA has approved a new 550-mg tablet of rifaximin (Xifaxan – Salix), a minimally absorbed oral antibiotic, to reduce the risk of recurrent hepatic encephalopathy (HE). A 200-mg tablet has been available for treatment of travelers’ diarrhea since 2004.

Nogapendekin alfa inbakicept-pmln (Anktiva – ImmunityBio), a first-in-class interleukin-15 (IL15) receptor agonist, has been approved by the FDA for use with Bacillus Calmette-Guérin (BCG) for treatment of patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. Such patients generally undergo bladder tumor resection, followed by intravesical BCG treatment, but treatment failure and cancer recurrence are common. The adenoviral vector-based intravesical gene therapy nadofaragene firadenovec-vncg (Adstiladrin)...

FK 506 (Fujisawa), an immunosuppressant similar in activity to cyclosporine (Sandimmune - Medical Letter 25:77, 1983), is currently under investigation in the USA, Europe, and Japan for prevention of organ transplant rejection.

Interferon β-1a (Avonex - Biogen), a recombinant form of human interferon β, has been approved by the US Food and Drug Administration (FDA) for treatment of relapsing forms of multiple sclerosis (MS). Interferon β-1a (Betaseron - Berlex), a recombinant analog of interferon β that differs from interferon β-1a in having a serine substituted for a cysteine and in not being glycosylated, was previously approved for this indication (Medical Letter, 35:61, 1993; BW van Oosten et al, Drugs, 49:200, 1995).

Myocardial perfusion imaging and stress echocardiography in patients who cannot exercise may require use of drugs. Arbutamine (GenESA - Gensia Automedics), a potent synthetic sympathomimetic, has recently been approved by the FDA for use with a computerized drug-delivery system in pharmacologic stress testing.

Once-a-week formulations of alendronate (Fosamax) in 35- and 70-mg tablets have now been approved by the FDA and are being heavily promoted for prevention and treatment of postmenopausal osteoporosis. A new formulation of risedronate (Actonel) for once-a-week use is under development and may be available next year.

The FDA has approved over-the-counter (OTC) sales of Plan B (Duramed), an emergency contraceptive package that contains two 0.75-mg tablets of levonorgestrel, to women ≥18 years old. Younger women still require a prescription. In one trial, two levonorgestrel 0.75-mg tablets taken 12 hours apart, the first within 72 hours after unprotected intercourse, decreased the pregnancy rate to 1%, compared to an expected rate of 8% (Task Force on Postovulatory Methods of Fertility Regulation, Lancet 1998; 352:428). How high doses of a progestin taken after coitus prevent pregnancy is unclear; they may...

On page 100 of the article "Major Changes in Endocarditis Prophylaxis for Dental, GI and GU Procedures", under the section Highest-Risk Procedures, the word "rubber" should have been omitted. Placement of orthodontic rubber bands is not a highest-risk procedure that justifies prophylaxis; placement of orthodontic (metal) bands is. An orthodontic band is a metal ring that surrounds the tooth and is pressed into place causing movement in closely-spaced teeth and sometimes bleeding when the bands are placed close to the gumline.

Chelation therapy involves oral administration, intravenous infusion or intramuscular injection of drugs that increase excretion of heavy metals. The Medical Letter’s last article on this subject found no evidence that it was effective for treatment of cardiovascular disease. Since then, off-label use of chelation therapy has expanded to include treating children with autism and adults with Alzheimer’s disease, cancer and other chronic diseases.

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