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| |  Health Canada Approves Pediatric Indication for Prevacid (Lansoprazole) for Children with Gastroesophageal Reflux Disease MONTREAL, QC -- February 10, 2005 - Abbott Laboratories, Limited announces that Prevacid® (lansoprazole), a commonly prescribed Proton Pump Inhibitor (PPI) for adults, has now been approved for pediatric gastroesophageal reflux disease (GERD) in Canada. Prevacid (lansoprazole) is now indicated for the short-term treatment of erosive and non-erosive GERD in children between 1 and 17 years of age. GERD is one of the most common oesophageal disorders in children. When stomach contents, such as food and gastric acid, frequently reflux out of the stomach and into the oesophagus, oesophageal tissue damage may occur. Common symptoms in children include regurgitation (spitting up), vomiting, chest pain (heartburn), abdominal pain, feeding resistance and difficulty swallowing. "The symptoms of GERD are uncomfortable for children, and can be disruptive for both the child and his or her family," said Beth Anderson, executive director of the Pediatric/Adolescent Gastro-oesophageal Reflux Association (PAGER). "We encourage parents who suspect their child may be suffering from GERD to approach their doctor and discuss symptoms, diagnosis and treatment options." About GERD However, further studies will be necessary to confirm this hypothesis. In children, GER has a distinct presentation from that in adults, with the diagnostic work-up based upon the patient's age as well as their presenting signs and symptoms. Like their adult counterparts, the early detection and treatment of GER in children may result in a better long-term outcome, improved quality of life, and a reduction in overall healthcare burden. While the treatment of GER in infants tends to be conservative (i.e. positioning during feeding and smaller feedings), its management in older children may, depending on the clinical situation, be similar to that of adults and includes lifestyle changes and pharmacological therapy. However, with persistent symptoms, acid suppression is the mainstay of GERD management in both children and adults. Several studies have demonstrated that acid suppression with a proton pump inhibitor is superior to histamine2-receptor antagonists. Among the proton pump inhibitors, lansoprazole has been the subject of published adult studies demonstrating its safety, in addition to its efficacy in a variety of conditions where reduction of acid secretion is required, such as GERD. Clinical results Indications According to Dr. Robert Issenman, Chief of Pediatric Gastroenterology and Nutrition, McMaster Children's Hospital in Hamilton, Ontario, "The proton pump class of medication is safe and effective treatment for esophagitis due to acid reflux. Current drug formats are convenient for use in pediatric patients and have been specifically tested in patients in this age group. Now that there is a pediatric indication for use, these medications can be used in children with greater confidence." About Prevacid (lansoprazole) For children who have difficulty swallowing capsules, the granules from a Prevacid capsule can be sprinkled on one tablespoon of applesauce or mixed into select juices (such as orange, apple or grape) and swallowed immediately. Contraindications and adverse reactions In pediatric GERD patients between the ages of 1 to 11, the most frequently reported adverse events were constipation and headache and between the ages of 12 to 17, headache and abdominal pain. Symptomatic response to therapy does not preclude the presence of serious stomach problems. About Proton Pump Inhibitors (PPIs)
SOURCE: Abbott
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