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Dexlansoprazole (formerly KAPIDEX, now DEXILANT) was approved by the Food and Drug Administration (FDA) in January 2009 to help heal and maintain the healing of an inflamed esophagus and for heartburn.
The original brand name of the drug was KAPIDEX. However, in March 2010, the FDA announced that manufacturer Takeda Pharmaceuticals had changed the name of the drug to DEXILANT because of reports of pharmacy errors involving the dispensing of the cancer drug bicalutamide (CASODEX), the...
Dexlansoprazole (formerly KAPIDEX, now DEXILANT) was approved by the Food and Drug Administration (FDA) in January 2009 to help heal and maintain the healing of an inflamed esophagus and for heartburn.
The original brand name of the drug was KAPIDEX. However, in March 2010, the FDA announced that manufacturer Takeda Pharmaceuticals had changed the name of the drug to DEXILANT because of reports of pharmacy errors involving the dispensing of the cancer drug bicalutamide (CASODEX), the pain medication morphine (KADIAN) and KAPIDEX due to the similarity of their names.
Dexlansoprazole is a member of a class of drugs known as proton pump inhibitors (PPIs). These drugs reduce gastric acid production. Normally when you eat, acid is secreted into the stomach to help digest food and absorb vitamin B12 and calcium. PPIs work by binding to and inhibiting the enzyme that secretes the acid (protons), blocking its function.
While dexlansoprazole is being sold as a new drug, it has been present as an ingredient in lansoprazole (PREVACID), another PPI already on the market and now available in generic form at a lower cost (generic lansoprazole costs approximately $18 for 30 pills, whereas PREVACID costs approximately $53 for the same quantity).
Lansoprazole is a 50:50 mixture of levolansoprazole and dexlansoprazole, two chemically identical, mirror-image compounds called optical isomers. Optical isomers have the same chemical structure but rotate polarized light either to the right (dexlansoprazole) or to the left (levolansoprazole). Optical isomers can be patented and sold separately as two different drugs.
When someone takes lansoprazole, half of each dose is dexlansoprazole and half is levolansoprazole.
Marketing an optical isomer as a “new” drug is one way a drug company may legally protect its patents and secure a virtual monopoly. Lansoprazole has been a big seller — in 2008, the drug was the fifth-highest grossing drug in the U.S., with nearly $3.3 billion in sales.
The manufacturer of dexlansoprozole, Novartis International, markets lansoprazole, as an over-the-counter (OTC) drug (PREVACID). This is the second OTC PPI, approved in March 2009. Omeprazole (PRILOSEC), another PPI that is sold OTC, was approved in June 2003.
The FDA’s basis for approving dexlansoprazole for treating heartburn
The FDA approved dexlansoprazole for treating heartburn associated with non-erosive gastroesophageal reflux disease (GERD) on the basis of one four-week clinical trial comparing 30 mg dexlansoprazole to placebo. The measure of effectiveness was the percentage of days (24-hour periods) that were heartburn free: 55 percent on dexlansoprazole vs. 19 percent on placebo.
However, one of the FDA experts who reviewed dexlansoprazole for approval commented that the drug had demonstrated no convincing evidence of additional benefit over existing therapies.
What You Can Do
There is no medical reason to switch from lansoprazole to dexlansoprazole.
There are nondrug treatments for heartburn that do not pose any safety concerns. Patients should try the following nondrug treatments before using any drugs.
Avoid:
- Alcohol
- Smoking
- Tight clothing
- Foods that trigger the condition, including fatty foods, onions, caffeine, peppermint and chocolate
It is best to avoid food and particularly alcohol within two or three hours of bedtime. When sleeping, you should elevate the head of the bed about six inches or sleep with extra pillows.
For both heartburn and ulcers, it is important to avoid drug-induced causes. For example, aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are known to cause ulcers. Ask your doctor if acetaminophen could be substituted for these drugs. The osteoporosis medications alendronate (FOSAMAX) and risedronate (ACTONEL) may also irritate the esophagus.
If these measures are not effective, try simple OTC antacids such as a generic aluminum hydroxide and magnesium hydroxide product (MAALOX, MAALOX TC).
If this does not relieve symptoms, you could try a stomach acid-blocking drug, known as a histamine2-blocker. This drug family includes cimetidine (TAGAMET), famotidine (PEPCID), nizatidine (AXID) and ranitidine (ZANTAC). These drugs partially prevent production of stomach acid. Histamine2-blockers relieve heartburn pain more quickly than PPIs and are available in both OTC and prescription strengths.
Consult with a physician if the OTC histamine2-blockers do not give adequate relief of symptoms after 14 days.
The Gastrointestinal (GI) Tract and Gastroesophageal Reflux Disease (GERD) The purpose of the gastrointestinal (GI) tract is to extract fluid and essential nutrients from the food we eat and to eliminate wastes. All the way along the tract, food is pushed by involuntary rhythmic muscular contractions called peristalsis. From the mouth, ingested food proceeds down the esophagus into the stomach. It is here that the process of digestion begins, with stomach acid being secreted to break down food. Enzymes that also facilitate the breakdown of chemicals in food, permitting absorption into the bloodstream, are released here and in subsequent sections of the GI tract. From the stomach, food passes into the small intestine, a relatively thin, long tube with three distinct portions: duodenum, jejunum and ileum. Enzymes from the pancreas and the gallbladder enter at the duodenum and have specific roles in the digestion of food. Generally several hours later, the remaining food passes from the ileum into the large intestine or colon. Water and some remaining nutrients are extracted in the large intestine, before the remains are excreted through the rectum as stool. Most of the time, the GI tract functions without problems, but there are a number of ways in which the system can go awry. There is a sphincter at the junction of the esophagus and the stomach that is supposed to prevent acidic stomach contents from backing up into the esophagus, which is not designed to tolerate such strong acids. When regurgitation occurs, it irritates the esophagus. This can cause the chest pain or discomfort that is sometimes called gastroesophageal reflux disease (GERD) or heartburn, as well as nausea and an unpleasant taste in the mouth. The problem is typically worse after meals, when the stomach is full and when lying down, because gravity no longer keeps the stomach contents in place. |
