Over-The-Counter Omeprazole (PRILOSEC OTC) ‹ There Are Better Choices For Heartburn -Worst Pills, Best Pills News article

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Over-The-Counter Omeprazole (PRILOSEC OTC) ‹ There Are Better Choices For

Heartburn

Worst Pills, Best Pills News article October, 2003

View the entire Worst Pills, Best Pills Newsletter for October, 2003 in PDF

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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 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 FDA¹s 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 OTC¹s 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 editors¹ 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.

NIGHTTIME HEARTBURN TREATMENTS: TRY THESE FIRST

There are non-drug treatments, with no safety concerns, and less expensive

drugs that may be effective for you that should be tried before you use

omeprazole (PRILOSEC), pantoprazole (PROTONIX), and rabeprazole (ACIPHEX) or

the other ³proton pump inhibitors² (PPIs): esomeprazole (NEXIUM) and

lansoprazole (PREVACID).

First, avoid food, and particularly alcohol, within two or three hours of

bedtime and elevate the head of the bed about six inches or sleep with extra

pillows. Try to avoid foods that trigger your condition, such as fatty

foods, onions, caffeine, peppermint and chocolate; and avoid alcohol,

smoking, and tight clothing. Also, avoid drugs known to aggravate ulcers,

especially aspirin, ibuprofen, and other nonsteroidal anti-inflammatory

drugs (NSAIDs) (see p. 261 of Worst Pills, Best Pills 1999 edition). Ask

your doctor if acetaminophen could be substituted for these drugs. Check

with your doctor about other medications that aggravate the esophagus such

as alendronate (FOSAMAX), a drug used to treat osteoporosis. If these are

not effective, try simple over-the-counter (OTC) antacids such as a generic

aluminum hydroxide and magnesium hydroxide product (MAALOX, MAALOX TC). Be

aware that long-term use of antacids also has risks: aluminum can cause bone

damage, and antacids containing magnesium can cause severe diarrhea. Too

much calcium and sodium also cause problems. If symptoms worsen or bleeding

occurs, call your doctor. If this does not relieve your symptoms, one of the

family of stomach-acid blocking drugs known as histamine-blockers can be

tried. This family includes cimetidine (TAGAMET), famotidine (PEPCID),

nizatidine (AXID), and ranitidine (ZANTAC). Histamine-blockers are available

in both OTC and prescription strengths. If the OTC histamine-blockers do not

give adequate relief of your symptoms after 14 days, it is time to consult

your physician.

RETAIL COST PER CAPSULE AT DRUGSTORE.COM

Prilosec OTC 20 mg

(over the counter) $0.67

Generic Omeprazole 20 mg (prescription) $3.33

Prilosec 20 mg

(prescription) $3.86

Nexium 20 mg

(prescription) $3.99