Green Light for Purple Pill

Tuesday, March 25, 2008

Kids ages 1 to 11 with gastroesophageal reflux disease now have a purple pill of their own. The Food and Drug Administration recently approved Nexium for kids after drugmaker AstraZeneca ran studies establishing the popular GERD drug's safety and tolerability among young patients.

The approval marks another success for an FDA program that offers manufacturers potentially lucrative six-month patent extensions for proving that their adult drugs can be used safely and effectively by children. In most instances the testing required under this program shows what dose works best; usually kids need smaller doses than adults, but sometimes they require larger ones.

Doctors were already free to prescribe Nexium (and other stomach-acid-suppressing drugs known as proton pump inhibitors) to children suffering from GERD, a condition in which stomach contents back up into the esophagus, causing heartburn or, more commonly in kids, chest pain, stomachache and coughing. But such "off-label" prescriptions can be tricky, particularly in children, in whom drugs do not always act as they do in adults, even when doctors try to adjust for body weight and metabolism.

About 100 adult drugs have been approved for pediatric use since 1997. Before it conducted the new research, AstraZeneca had already received an extension on Nexium's patents (which expire between 2014 and 2018) for earlier clinical research.

As a result of the company's studies, Nexium dosage for kids was set at 10 to 20 milligrams, compared with the adult dose of 20 to 40. Kids-strength Nexium is now available by prescription as a 20 mg time-release capsule; a 10 mg formulation -- lime-flavored granules to be mixed with water -- will be available later this year. Side effects include headache, diarrhea, abdominal pain and sleepiness.

Rockville pediatrician John Choi said he sees a fair amount of GERD among his school-age patients, but he's not wowed by Nexium's new availability. "There are already a few drugs on the market for kids" with this condition, he said. "We've had pretty good success" using other proton pump inhibitors such as Prevacid (available by prescription for kids ages 1 to 17) and H2 blockers (which keep acid from backing up into the esophagus) such as Zantac and Pepcid (available by prescription for children).

-- Jennifer Huget


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