Therapeutics & Drugs Briefs

Rotavirus Vaccine on Hold

Source: MMWR Morb Mortal Wkly Rep 1999;48:577-581.

Based on concerns of a possible association between the administration of rotavirus vaccine (Rotashield) and an increased risk of intussusception in children, the American Academy of Pediatrics and the CDC are recommending that the use of this vaccine be suspended until the availability of additional safety data. Children scheduled to receive this vaccine, including those who have already begun the series, should not receive it until further notice. Any child who has recently received the vaccine and who develops gastrointestinal symptoms, including persistent vomiting, abdominal distention, severe abdominal pain, and black or bloody stools, should be urgently evaluated. Clinicians should be aware of this possible adverse event and are urged to report this or any other postvaccination event to the Vaccine Adverse Event Reporting System at htm (1-800-822-7967). Data from an ongoing case-control study should be available by November 1999.

Terbinafine Superior to Itra in Toenails

Source: Evans EG, et al. BMJ 1999;318:1031-1035.

Because therapeutic concentrations of itraconazole persist in the nail bed for several days, some experts advocate that, for the treatment of onychomycosis, the administration of this azole should be cycled. In contrast to itraconazole, which is fungistatic, terbinafine is a newer allylamine antifungal agent that has cidal activity against most dermatophytes. In a double-blind, randomized, controlled trial, 496 patients with onychomycosis were randomized to receive either continuous terbinafine 250 mg daily for either 12 or 16 weeks or itraconazole 400 mg daily for one week of every month for 12 or 16 weeks. Eligible patients had distal subungual or total dystrophic nail disease confirmed by culture as well as KOH.

Continuous terbinafine was substantially better, resulting in clinical cures (defined as 100% toenail clearing) in 54% of patients at 12 weeks and 60% of patients at 16 weeks. In contrast, only 32% of patients receiving itraconazole were clinically cured. Mycological cures were achieved in 76-80% of patients receiving terbinafine and 38-49% receiving itraconazole. Both drugs were well tolerated and the frequency of side effects was similar. While daily terbinafine is superior to intermittent itraconazole in the treatment of onychomycosis, clinicians should keep in mind that 20-40% of patients may fail three to four months of therapy and require a longer course of treatment.

The Therapeutics & Drugs Briefs were written by Carol A. Kemper, MD, FACP, Clinical Associate Professor of Medicine, Stanford University, Division of Infectious Diseases; Santa Clara Valley Medical Center.