Aciphex.

Aciphex (rabeprazole sodium, Eisai Corporation)

The Food and Drug Administration approved an adolescent indication for Aciphex (rabeprazole sodium) 20 mg for short-term treatment of gastroesophageal reflux disease in patients 12 years and older.

* Recommended Dosage: A 20-mg oral dose daily for up to 8 weeks is recommended for adolescents aged 12 years and over. The tablets can be taken with or without food.

* Special Considerations: Headache and nausea were adverse effects that occurred in 2% or more of 111 adolescent patients treated with Aciphex. There were no adverse events not previously reported in adult studies (pain, pharyngitis, flatulence, infection, and constipation).

Closely monitor patients for drug interactions, especially if they are taking warfarin, cyclosporine, or clarithromycin.

* Comment: Safety and efficacy are based on a multicenter, randomized, open-label study of 111 patients aged 12-16 years treated with 10 mg or 20 mg of Aciphex for up to 8 weeks. Severity and frequency of gastroesophageal reflux disease (GERD) symptoms were reduced at 8 weeks, compared with baseline, according to a news release. Use in adolescents also is supported by extrapolation of data from previous adult clinical studies. The FDA has approved a number of indications in adults since August 1999.

"GERD is becoming a much more common problem--in general and especially among adolescents. We are seeing more in the younger age group with dietary indiscretions and obesity," Dr. Stephen Brunton, a family physician in private practice in Charlotte, N.C., said.

"It is very reassuring for clinicians to know the studies have been done and the FDA has given its ... seal of approval," Dr. Brunton said.

Aciphex blocks gastric acid secretion and is a member of the class of substituted benzimidazole proton pump inhibitors, which also includes esomeprazole (Nexium), pantoprazole (Protonix), lansoprazole (Prevacid) and omeprazole (Prilosec).

"It's a very safe class of medications, the most potent acid blockers, and can be used first line in our patients with GERD," Dr. Brunton said.

"There are subtle differences between the newer agents, and the choice depends on a person's experience," added Dr. Brunton, who disclosed he is a consultant for Eisai Corporation.

BY DAMIAN McNAMARA, MIAMI BUREAU