FDA Clears Astra’s GERD Drug Nexium for Children Ages 1-11 Years

By Anna Boyd
13:29, February 29th 2008
73 votes
Vote this story
FDA Clears Astra’s GERD Drug Nexium for Children Ages 1-11 Years

The U.S. Food and Drug Administration on Thursday approved esomeprazole magnesium, also known as Nexium for short treatment of gastroesophageal reflux disease (GERD) in children ages 1 to 11.

The FDA cleared two formulations, a delayed-release capsule, and esomeprazole magnesium liquid, in 10-mg or 20-mg doses, half the dosage for patients aged 12 to 17.

“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,” Julie Beitz, MD, director of the FDA’s Office for Drug Evaluation III in the Center for Drug Evaluation and Research said quoted by WebMD.

Nexium, manufactured by AstraZeneca of Wilmington, Del., was the world’s second-best selling drug in 2006, according to health care research firm IMS Health. The drug is known as a proton pump inhibitor, which reduces the amount of acid produced in the stomach and helps heal damage to the esophagus caused by excess acid.

The approval is based on data extrapolated from previous studies done in adults, as well as studies done in children, the FDA said. In one study, 109 GERD patients aged 1-11 were treated with Nexium once daily for up to eight weeks to evaluate Nexium’s safety and tolerability. Most of the patients showed healing of their esophageal erosions after eight weeks of treatment.

The most common adverse reactions in children treated with esomeprazole magnesium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth, and sleepiness. Beitz said that children treated with the drug “should be monitored by their physicians for any adverse drug reactions.

The safety and efficacy of esomeprazole magnesium has not been established in children less than one year of age, the FDA said.



© 2007 - 2009 - eFluxMedia
Tags: FDA, Astra, GERD, Nexium
dotclear

Other News in

Engineered Goat Produces Medicine

The progress made by medicine in the latest years has been truly fantastic, as new technologies and drugs emerged, new ways of conducting surgeries have become available, but some developments just...

Study: Bird Flu Could Be Resistant To Drugs

Study: Bird Flu Could Be Resistant To Drugs

Scientists doubt if anti-viral medication would have any effect in the case of a bird flu pandemic, as the virus is known for its extraordinary ability to mutate very fast. University of Colorado...

An Early C-Section Is Definitely Not The Best Choice

An Early C-Section Is Definitely Not The Best Choice

According to a new study, early elective cesarean sections pose serious risks to newborns. The study, published in the New England Journal of Medicine , found that babies delivered via a scheduled...

Gene Predicts the Likelihood of ALL Recurrence

Gene Predicts the Likelihood of ALL Recurrence

  Acute lymphoblastic leukemia or ALL is the most common type of cancer in children affecting about one in 30,000 each year. Current drugs for the disease have put the cure rates close to 80...

Teens Tackle Risky Behaviour on MySpace

Teens Tackle Risky Behaviour on MySpace

Many teens and college students enjoy talking about sex, drugs and violence on MySpace or Facebook, a new study shows. But they are disposed to change their risky behaviour if they are given the...

dotclear
Latest videos in Health
Plastic Bags Help to Save...
Nuclear knuckles
Restoring the pee-h balance
Bird flu alert in Hong Kong
Ireland in pork product alert

dotclear
Health You are here: Health
» Science   » Health   
E-mail To A Friend Print RSS Text size: Decrease font size Increase font size
dotclear
dotclear
dotclear
Most Popular in Health
UAMS Scientists To Begin Testing Breast Cancer VaccineUAMS Scientists To Begin Testing Breast Cancer Vaccine

» read full story
dotclear

Interested In This Topic?

News Alert will keep you informed. Find out more.
dotclear
Photos Gallery
dotclear
Today's Latest News
Samsung Rolls up New LCD TVs, Plans to Increase Sales by 10 PercentSamsung Rolls up New LCD TVs, Plans to Increase Sales by 10 Percent

» read full story
dotclear