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Published on 29 February 2008

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Watchdog approves Nexium for GERD

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The Food and Drug Administration (FDA) has approved Nexium (esomeprazole magnesium) for short-term use in children aged between one and 11 who are suffering from gastroesophageal reflux disease (GERD).

The regulator gave the green light for two types of the treatment to be used, one a delayed-release capsule and the other a liquid form.

Nexium is approved for 10mg or 20mg daily doses in the children, while patients between 12 and 17 years old can have 20mg or 40mg.

The medication belongs to a class of drugs known as proton pump inhibitors (PPIs), which reduce the amount of acid produced in the stomach, and help heal erosions in the lining of the oesophagus known as erosive oesophagitis.

It is manufactured by AstraZeneca, and side-effects include headache, diarrhoea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. It is not approved for patients less than one-year-old.

Dr Julie Beitz, director of the FDA’s Office of Drug Evaluation III at the Center for Drug Evaluation and Research, said: “This approval provides important information for appropriate dosing for children ages 1-11 years with GERD.

“Children prescribed this drug should be monitored by their physicians for any adverse drug reactions.”

Copyright © PA Business 2008

AstraZeneca



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