The prescription drug lansoprazole, sold under the brand name Prevacid, has been an effective method of short-term treatment for sufferers of gastroesophageal reflux disease (GERD) for several years. Until recently, however, the FDA had only vouched for the drug’s safety when administered to adults and younger patients, approving the drug for children ages one to 12 and adults over 17.Now, teens who suffer from GERD and its related symptoms have a new reason to be optimistic about treatment. On June 30, the maker of Prevacid, TAP Pharmaceutical Products, Inc. (a joint venture between Abbott Laboratories, based in Illinois, and Takeda Chemical Industries, Ltd., of Osaka, Japan) published a press release regarding the FDA’s approval of the use of Prevacid in adolescent patients from the ages of 12 to 17.
The FDA response came after the results of a TAP study of 87 teens between 12 and 17 years old. The participants were given either 15 or 30 mg doses of Prevacid once daily. 89 percent of the patients displayed mild to moderate GERD symptoms. The 64 patients who had not experienced erosion of the esophagus as a result of their condition received 15 mg doses for eight weeks, while the 23 who had erosive esophagitis (inflamed and damaged esophageal tissue) were given 30 mg doses for 12 weeks.
21 of the 23 patients with erosive esophagitis were healed after eight weeks, which represents a success rate of 95 percent. The drug was not found to have any major adverse effects in addition to its benefits, though in rare instances a patient may be hypersensitive to a component of the drug. Common side effects included headache, abdominal pain, nausea and dizziness, but each was seen in less than 10 percent of the patients studied.
Prevacid is a proton pump inhibitor. Proton pump inhibitors work by preventing the production of acid in the stomach, which in turn prevents the acid from flowing into the esophagus, where it can cause coughing, sleep apnea (periodic temporary stops in breathing), asthma, heart problems, lung problems and, in some cases, even the growth of precancerous cells in the esophagus.
While there are a number of proton pump inhibitors on the market today, Prevacid is the only one that has been approved for use in young patients. These new findings about the drug’s efficacy in adolescents make the drug a welcome "bridge" from pediatric to adult treatment; if used properly, experts say, it can potentially prevent the early onset of GERD-related illness. When used in conjunction with dietary and lifestyle modifications, Prevacid may be instrumental in allowing teens with GERD to lead relatively normal, symptom-free lives.
One key difference between Prevacid and other, similar drugs is that Prevacid is available in liquid form, so that children who are unable to properly take pills can still receive the benefits of the drug. There is also a quick-dissolving tablet that can be held in the mouth for about a minute and then swallowed when it disintegrates into small particles.
"This approval is an important milestone for PREVACID in the treatment of acid reflux disease," noted H. Thomas Watkins, the president of TAP. "PREVACID is now available to help a larger group of patients, further reinforcing its leadership position in the PPI market."
Prevacid can also be used for the healing, prevention, and control of digestive ulcers, as well as for certain congenital syndromes or disorders that cause the body to produce abnormal amounts of digestive acid.
