Terfenadine (Seldane - Marion Merrell Dow) and astemizole (Hismanal - Janssen) are nonsedating antihistamines widely used to treat symptoms of allergic rhinitis (Medical Letter, 27:65, 1985; 31:43, 1989). Both are available without a prescription in Canada, and the US Food and Drug Administration is apparently considering terfenadine for over-the-counter availability in the USA.

Nalmefene (Revex - Ohmeda), an i methylene analog of naltrexone (Trexan), is a long-acting opioid antagonist that has been approved by the US Food and Drug Administration for reversal of postoperative opioid drug effects, including respiratory depression, sedation and hypotension and for management of known or suspected opioid overdose in the emergency department. The only other opioid antagonists available in the USA are naloxone (Narcan), which is also injectable but has a short duration of action, and naltrexone, which has a long duration of action but is marketed only for oral...

High-dose chemotherapy followed by bone marrow transplantation continues to be widely used in the treatment of malignant diseases (Medical Letter, 37:25, 1995). The source of the transplant has been autologous or allogeneic bone marrow or, more recently, stem and progenitor cells harvested from peripheral blood (Medical Letter, 37:71, 1995). Now, blood taken from the umbilical cord and placenta of a newborn infant is being tried as a source of cells to restore the bone marrow. A single collection of umbilical cord blood contains about as many progenitor cells as most autologous bone...

Zolmitriptan (Zomig - Zeneca), a selective serotonin (5-HT1)-receptor agonist, is now available in the USA for oral treatment of migraine headache. Zomitriptan structurally resembles sumatriptan (Imitrex - Medical Letter 34:91, 1992). Drugs currently used for acute treatment of migraine include injectable, oral and nasal spray formulations of sumaptriptan, injectable dihydroergotamine, dihydroergotamine nasal spray, ergotamine tartrate alone or with caffeine, and various analgesics. Anoterh 5-HT1-receptor agonist, naratriptan (Amerge - Gaxo Wellcome), has been approved by the FDA but has not...

Gemtuzumab ozogamicin, a monoclonal antibody bound to a cytotoxic antibiotic, has been approved by the FDA for treatment of patients with CD33-positive acute myeloid leukemia (AML) in first relapse who are more than 60 years old and may not be able to tolerate cytotoxic chemotherapy

High doses of beta carotene, vitamin C, vitamin E and zinc oxide are now being promoted to the general public to "preserve eye health" (Ocuvite PreserVision), "promote retinal and visual health" (VisiVite) and "preserve healthy vision" (ICaps). Internet advertisements for these products all refer to a clinical trial, the Age-Related Eye Disease Study (AREDS), which was conducted in patients with age-related macular degeneration (AMD).

The FDA has approved efinaconazole 10% solution (Jublia – Valeant) for topical treatment of toenail onychomycosis due to Trichophyton rubrum and/or Trichophyton mentagrophytes. It is the first topical triazole antifungal drug to be approved for this indication. A topical oxaborole antifungal solution, tavaborole 5% (Kerydin – Anacor), also recently approved by the FDA for the same indication will be reviewed in a future issue.

The FDA has approved Liletta, an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy for up to 3 years. The fourth IUD to be approved in the US, and the third that releases levonorgestrel, Liletta is comarketed by Actavis and Medicines360, a nonprofit women's health pharmaceutical company. The wholesale cost of Liletta is similar to that of other IUDs (see Table 1), but the manufacturer offers programs that significantly reduce the cost for commercially-insured patients and clinics serving low-income women.

An injectable foam formulation of the sclerosing agent polidocanol (Varithena – Provensis/BTG) has been approved by the FDA for treatment of incompetent veins and visible varicosities of the great saphenous vein system. It is the first foam therapy to be approved for this indication, but polidocanol and other sclerosants have been used for years as foam formulations compounded by physicians. Polidocanol is also available in a liquid formulation (Asclera) to treat smaller veins. Sodium tetradecyl sulfate (Sotradecol) is FDA-approved in a liquid formulation for use in...

The FDA has approved obiltoxaximab (Anthim – Elusys Therapeutics), a toxin-targeting monoclonal antibody, for treatment of inhalational anthrax in combination with antibacterial drugs and prophylaxis of inhalational anthrax when other therapies are unavailable or inappropriate. Raxibacumab, another monoclonal antibody, was approved earlier for the same indication. Like raxibacumab, obiltoxaximab is being manufactured only for the CDC national stockpile and is not available for commercial sale.