The FDA issued a public health advisory on March 10, 2005 warning about a risk of cancer with topical formulations of tacrolimus (Protopic) and pimecrolimus (Elidel) used to treat eczema in adults and children more than 2 years old. Elidel has been heavily promoted to the general public on television. The warning was based on reports of dose-related cancer in animals and 29 reports of cancer (including 8 skin malignancies and 12 lymphomas) in adults and children treated with these immunosuppressive drugs. Cause and effect have not been established. When Protopic was first marketed, The Medical...

The standard antithrombotic therapy for treatment of patients with acute coronary syndrome (ACS) is dual antiplatelet therapy with aspirin and clopidogrel (Plavix) or another thienopyridine, plus a parenteral anticoagulant while the patient is hospitalized, followed by antiplatelet therapy alone after discharge. The addition of the oral anticoagulant warfarin (Coumadin, and others) to dual antiplatelet therapy is generally not recommended for this indication because of fluctuations in its anticoagulant effect and the risk of bleeding. A recently published trial found that addition of...

A Medical Letter reader asked if human chorionic gonadotropin (hCG; Novarel, Pregnyl and others) has any value as an adjunct to diet, adding that it is widely used for this indication in his area. Normally secreted by the placenta during pregnancy, the main therapeutic use of this gonad-stimulating polypeptide, which is not absorbed from the GI tract, has been in the parenteral treatment of infertility.1 It has also been injected by male athletes as an undetectable stimulus to production of testosterone.2Use of hCG as an adjunct to diet goes back to the 1950’s, when a British physician named...

Atazanavir (Reyataz - Bristol-Myers Squibb), a new protease inhibitor (PI), and emtricitabine (Emtriva - Gilead), a nucleoside analogue reverse transcriptase inhibitor (NRTI) chemically similar to lamivudine, have been approved by the FDA for treatment of HIV-1 infection. Both are taken once daily, unlike most anti-HIV drugs.

Implantable cardioverter defibrillators (ICDs) are widely used in patients at risk for sudden cardiac death (SCD) because these devices have been highly successful in terminating life-threatening ventricular arrhythmias and in increasing survival.

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi) for second-line treatment of adults with moderately to severely active rheumatoid arthritis (RA). It is the second IL-6 inhibitor to be approved for this indication; tocilizumab (Actemra) was approved earlier.

The FDA has approved Anjeso (Baudax Bio), an IV formulation of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, for once-daily treatment of moderate to severe pain in adults. Oral meloxicam (Mobic, and others), which is only indicated for treatment of chronic pain associated with osteoarthritis or rheumatoid arthritis, has been available for 20 years. IV formulations of ketorolac, ibuprofen (Caldolor), and acetaminophen (Ofirmev) are also available for treatment of pain.

The FDA has approved sotatercept-csrk (Winrevair – Merck), a first-in-class activin signaling inhibitor, to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events in adults with WHO Group 1 pulmonary arterial hypertension (PAH).

Temafloxacin (Omniflox - Abbott) and lomefloxacin (Maxaquin - Searle) are the latest fluoroquinolone antimicrobial agents to be approved by the US Food and Drug Administration (FDA) for oral treatment of various infections. Previously marketed include norfloxacin (Noroxin - Medical Letter, 29:25, 1987), ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), and ofloxacin (Floxin - Medical Letter, 33:71, 1991). Norfloxacin is marketed only for treatment of urinary tract infections, and lomefloxacin only for treatment of urinary tract infections and bronchitis known to be caused by...

Montelukast sodium (Singulair - Merck), a leukotriene receptor antagonist, has been approved by the US Food and Drug Administration (FDA) for oral prophylaxis and chronic treatment of asthma in adults and children at least 6 years old. It is the third 'leukotriene modifier' to become available in the USA; zafirlukast (Accolate - Medical Letter, 38:111, 1996) and zileuton (Zyflo - Medical Letter, 39:18, 1997) were marketed previously. Neither zafirlukast nor zileuton has been approved by the FDA for use in children less than 12 years old. Leukotriene modifiers are not recommended for...