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FDA Approves Nexium for Use in Children Ages 1-11 Years
The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.
"This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions."
Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis.
FDA approved the use of Nexium in patients 1 to 11 years for short-term treatment of GERD based upon the extrapolation of data from previous study results in adults to the pediatric population, as well as safety and pharmacokinetic studies performed in pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate its safety and tolerability. Most of these patients demonstrated healing of their esophageal erosions after eight weeks of treatment.
The most common adverse reactions in children treated with Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness. The safety and efficacy of Nexium has not been established in children less than one year of age.
Nexium is manufactured by AstraZeneca of Wilmington, DE.
tag: FDA Approval, Drug Approval, Nexium, esomeprazole magnesium, gastroesophageal reflux disease, GERD, CDER, erosive esophagitis, AstraZeneca
1 comment:
My name is Jon Star and i would like to show you my personal experience with Nexium.
I am 34 years old. Great medicine. I only hope that I don't become dependant on it. But as my esphogus heals then maybe I'll be able to take an OTC PPI if my symtoms re-occur and I catch them ASAP! Can't wait for a generic. BLUE CROSS of MA won't pay for Nexium unless I start on generic Prilosec, then Protonix, then if both of those failed, they would pay for Nexium. I hate BLUE CROSS! My Dr. was great in giving me 7 weeks of samples when he heard this and Aztra-Zeneca gave me a 7-day coupon I re-deemed at my local pharmacy(with a written 7-day script from my Dr.)
No major side effect. Sometimes a feeling of indigestion/bloated, possibly due to low or no stomach acid as a result of a PPI. So, I am sure to chew my food well and not to eat large portions. I have introduced foods/drinks back into my diet, that before taking Nexium would otherwise bring-on reflux symtoms. Fruit juices and citric acid containing drinks still are bothersome. But, I've eaten Pizza, and am able to drink coffee/tea, both decaf(not to excess though.) A little at a time. I do not drink any alcohol! I still limit any food intake 3 hours before bedtime and try to sleep on my left side. Nexium has given me the greatest relief as compared to all OTC H2 and OTC PPI's. I'm on week 5 of an 8 week treatment.
I hope this information will be useful to others,
Jon Star
Nexium Prescription Medication
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