The 2006 Medical Letter article on the then-new varicella-zoster vaccine concluded that Zostavax appears to be safe and effective in protecting patients ≥60 years old against herpes zoster and postherpetic neuralgia, especially in reducing the severity and duration of the disease.1 Some new information has recently become available.

CLINICAL STUDIES — A Veterans Administration randomized, double-blind trial enrolled more than 38,000 patients ≥60 years old and followed them for a mean of 3.4 years after administration of Zostavax or placebo. Since the efficacy of the vaccine had been demonstrated previously (51% in preventing zoster and 67% in preventing postherpetic neuralgia), the objective of this study was to examine its safety. Transient varicella-like rash occurred at the inoculation site in 0.11% of vaccine recipients and in 0.04% of patients who received a placebo injection. Erythema, swelling, pain and tenderness at the injection site were more frequent and more severe with the vaccine than with placebo. There were no other significant differences. Serious adverse events occurred in 1.4% of patients in each group.2

USE — Despite its efficacy and the frequency and morbidity of herpes zoster, this vaccine is hardly used. One study in 2007 found that only 2% of patients ≥60 years old had received it.3 A 2008 survey found that 7% of potential recipients had been vaccinated.4 A study of the reasons for such sparse usage concluded that the expense ($194 wholesale), the need for a freezer to store the vaccine (a vaccine that can be kept in a refrigerator is available in Europe), and reimbursement through Medicare Part D, which generally provides pharmacy benefits, rather than Part B, which physicians are more familiar with, were contributing factors.5

CONCLUSION — The efficacy of the herpes zoster vaccine (Zostavax) was well established before the FDA approved it in 2006. Several years’ use has now provided more data supporting the safety of the vaccine. It deserves wider use.

1. Herpes zoster vaccine (Zostavax). Med Lett Drugs Ther 2006; 48:73.
2. MS Simberkoff et al. Safety of herpes zoster vaccine in the shingles prevention study. Ann Intern Med 2010; 152:545.
3. PJ Lu et al. Herpes zoster vaccination among adults aged 60 years or older in the United States, 2007: uptake of the first new vaccine to target seniors. Vaccine 2009; 27:882.
4. JS Schiller and GL Euler. Vaccination coverage estimates from the National Health Interview Survey: United States, 2008. Atlanta: Centers for Disease Control and Prevention 2009. Accessed at www.cdc.gov/nchs/data/hestat/vaccine_coverage/vaccine_coverage.pdf on 12 May 2010.
5. LP Hurley et al. Barriers to the use of herpes zoster vaccine. Ann Intern Med 2010; 152:555.

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Two combinations of an inhaled corticosteroid with an inhaled long-acting beta2-agonist are approved by the FDA for use in patients with COPD: fluticasone/salmeterol (Advair Diskus) and budesonide/formoterol (Symbicort). A Medical Letter reader has questioned the safety of using corticosteroid inhalers in patients with this disorder. No single-agent inhaled corticosteroid inhaler is approved for this indication.

The FDA has approved romidepsin (Istodax – Celgene), an IV histone deacetylase (HDAC) inhibitor, for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The most common types of CTCL are mycosis fungoides, a low-grade lymphoma usually confined to the skin, and Sézary syndrome, a more aggressive disease with malignant lymphocytes in the blood. Both can progress to fatal systemic involvement. Romidepsin is the second HDAC inhibitor approved for this indication; vorinostat (Zolinza), an oral HDAC inhibitor, was approved earlier.

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