The FDA has approved an agonist/antagonist combination of morphine and naltrexone (Embeda – King) for treatment of chronic moderate to severe pain requiring around-the-clock analgesia for an extended period of time. The addition of naltrexone is intended to prevent abuse of morphine.

When the nicotine receptor partial agonist varenicline (Chantix – Pfizer) was first marketed, The Medical Letter concluded that it was moderately effective in increasing smoking cessation rates.1 More recent publications and the clinical experience of Medical Letter consultants now suggest that varenicline is the most effective drug available for this indication, more effective than nicotine replacement therapy or bupropion SR (Zyban).2,3 A word of caution: exacerbations of psychiatric illness have been reported in patients who took higher-than-recommended starting doses of varenicline.4,5

1. Varenicline (Chantix) for tobacco dependence. Med Lett Drugs Ther 2006; 48:66.
2. P Wu et al. Effectiveness of smoking cessation therapies: a systemic review and meta-analysis. BMC Public Health 2006; 6:300.
3. K Cahill et al. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev 2007; (1):CD006103.
4. R Freedman. Exacerbation of schizophrenia by varenicline. Am J Psychiatry 2007; 164:1269.
5. I Kohen and N Kremen. Varenicline-induced manic episode in a patient with bipolar disorder. Am J Psychiatry 2007; 164:1269.

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The Medical Letter review of Palladone (hydromorphone HCl) extended-release capsules (March 14, 2005) warned that a lethal dose could be released if the new formulation was taken with alcohol. Because of that risk, the FDA asked the manufacturer (Purdue) to withdraw the drug from the market (FDA News. July 13, 2005; FDC Reports – “The Pink Sheet” July 18, 2005; 67:3).

A once-daily extended-release (ER) oral formulation of the opioid analgesic hydromorphone hydrochloride (Palladone - Purdue Pharma) has been approved by the FDA for treatment of opioid-tolerant patients with persistent moderate to severe pain. Hydromorphone HCl, a semisynthetic congener of morphine and active metabolite of hydrocodone that has been used since the 1920s, is also available in immediate-release oral, injectable and suppository forms (Dilaudid, and others).

Methamphetamine, a highly addictive synthetic sympathomimetic, has again become important as a drug of abuse in the US. Its resurgence has been associated with unsafe sexual practices that have resulted in an increase in HIV transmission, particularly among men who have sex with men (SJ Semple et al, J Subst Abuse Treat 2002; 22:149; A Urbina and K Jones, Clin Infect Dis 2004; 38:890).