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The Food and Drug Administration (FDA) approved omeprazole (PRILOSEC) for over-the-counter (OTC) use on June 20, 2003. The new product will be called Prilosec OTC. As noted above, omeprazole is a member of the family of drugs known as proton pump inhibitors. The other members of this family that remain as prescription only drugs are esomeprazole (NEXIUM), lansoprazole (PREVACID), pantoprazole (PROTONIX), and rabeprazole(ACIPHEX).
This article is based in large part on FDA scientific reviews...
The Food and Drug Administration (FDA) approved omeprazole (PRILOSEC) for over-the-counter (OTC) use on June 20, 2003. The new product will be called Prilosec OTC. As noted above, omeprazole is a member of the family of drugs known as proton pump inhibitors. The other members of this family that remain as prescription only drugs are esomeprazole (NEXIUM), lansoprazole (PREVACID), pantoprazole (PROTONIX), and rabeprazole(ACIPHEX).
This article is based in large part on FDA scientific reviews and other documents that are required to be made available to the public prior to FDA advisory committee meetings as a result of litigation brought by the Health Research Group. We have found that it is no longer possible to form an independent opinion of the therapeutic value of a new drug, or of a new use for an old drug, by relying solely on the published medical literature, because that literature may be (and sometimes is) used as a form of misleading advertising.
Omeprazole was originally approved as a prescription drug in 1989. At one time, according to the market research firm IMS, omeprazole was the number-one selling proton pump inhibitor in the world. Prescription omeprazole is produced by AstraZeneca of Wilmington, DE. Prilosec OTC will be sold by the consumer products giant Proctor & Gamble.
The application for Prilosec OTC was reviewed on two occasions in joint meetings of the FDA’s Nonprescription Drugs Committee and its Gastrointestinal Drugs Advisory Committee. The first meeting was held on October 20, 2000. In this meeting the manufacturer attempted to get the drug approved for relief of heartburn, acid indigestion and sour stomach, and the 24-hour prevention of symptoms. These are the same OTC uses approved by the FDA for the family of drugs known as histamine-2 blockers that includes cimetidine (TAGAMET), famotidine (PEPCID), nizatidine (AXID), and ranitidine (ZANTAC). The committees felt that adequate evidence had not been presented to support these uses for Prilosec OTC and recommended against approval of the drug.
Two studies submitted to the FDA failed to show that a single dose of omperazole at 20 milligrams was better than placebo for the treatment of episodic heartburn.
AstraZeneca/Proctor & Gamble submitted new research to the FDA in February 2002 and a second advisory committee meeting was held on June 21, 2002 to review this submission for Prilosec OTC’s approval. This time the two companies came up with a new proposed use for the drug, the prevention of frequent heartburn which was defined as heartburn on two or more days a week.
Two studies were submitted to the FDA to assess the efficacy of omeprazole in the prevention of heartburn. Those eligible to participate in the studies had to have had heartburn of greater than one month duration, with a frequency of at least two heartburn episodes per week, and previously had their heartburn relieved by a simple antacid or one of the OTC histamine-2 blockers. These studies looked for the proportion of patients with no heartburn over 24 hours and no heartburn over 24 hours at the end of 14 days of omeprazole treatment. The FDA review of these studies found:
• A substantial proportion of patients experienced no heartburn on day 1 or day 14 in the placebo group.
• The therapeutic gain with omeprazole was modest on day 1, though it was statistically significant.
• The therapeutic gain increased on day 14, confirming that the maximum benefit of treatment relies on the consecutive dosing of omeprazole.
• Approximately 30 percent of the patients experienced breakthrough heartburn on day 14.
• Patients with a lower frequency of heartburn did better than those with a high frequency of heartburn at the beginning of the study; still, the therapeutic gain was small.
• There was approximately a 40 percent treatment failure rate after 14 days in patients with a high frequency of heartburn at the beginning of the studies, with the benefit being lost within three days of stopping omeprazole treatment.
There are some important drug interactions with omeprazole. Omeprazole can prolong the elimination of the tranquilizer diazepam (VALIUM), warfarin (COUMADIN) an anticoagulant, and the seizure medication phenytoin (DILANTIN), from the body. Thus the effect of these drugs can be increased and it may be necessary to adjust their doses. There have also been reports of interactions between omeprazole and cyclosporine (NEORAL, SANDIMMUNE) a drug to prevent organ transplant rejection; a drug used to help alcoholics, disulfiram (ANTABUSE); and the benzodiazepines
Because omeprazole has a long-lasting effect in reducing the amount of acid in the stomach, it is theoretically possible that omeprazole may interfere with absorption of drugs where stomach acid is an important factor in their absorption, such as the antifungal drug ketoconazole (NIZORAL), some of the ampicillin antibiotics, and iron supplements.
The table below lists the retail prices of OTC omeprazole, generic and brand name prescription omeprazole, and esomeprazole (NEXIUM). We included esomeprazole (NEXIUM) on the list because it is really omeprazole and has no therapeutic advantage over omeprazole. It was developed by AstraZeneca, the producer of omeprazole, to extend its monopoly position in the very lucrative PPI market (see Worst Pills, Best Pills News November 2001). The prices listed in the table attest to a market in which consumers have inadequate information about the comparative quality of drugs — in other words a dysfunctional market.
The Medical Letter on Drugs and Therapeutics, a respected source of independent drug information written for pharmacists and physicians, reviewed Prilosec OTC in their August 4, 2003 issue and concluded:
Omeprazole magnesium (Prilosec OTC) is effective for treatment (really prevention) of frequent heartburn, but it can take days to relieve symptoms. The OTC labeling warns against using it for more than 14 days, but within 5 days after stopping the drug, the incidence of heartburn was the same as in patients who took placebo. An H 2 -blocker [histamine-2 blocker] with or without an antacid is preferred for prevention or acute treatment of sporadic symptoms.
We agree with the Medical Letter editors’ conclusion as far as it goes. There are effective things that you can do before taking either an OTC or prescription drug for preventing or treating acute heartburn. See the information in the box below.
What You Can Do
You should try the non-pharmacologic interventions listed in the box below before trying antacids, histamine-2 blockers, or, as a last resort, proton pump inhibitors.
If you classify yourself as a person with frequent heartburn, that is heartburn more than two days per week, and the interventions recommended above have failed, you should be under the care of a physician.
