FDA Approves Prilosec OTC to Treat Frequent Heartburn
June 20, 2003 -- The Food and Drug Administration (FDA) today announced the
approval of Prilosec OTC (omeprazole), the first over-the-counter treatment for
frequent heartburn.
"Today's approval of over-the-counter Prilosec is yet another example
of the important role FDA serves in improving access to safe and effective
treatments for conditions that people can treat themselves," said Mark B.
McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "As has been the case
for many other over-the-counter switches, the availability of Prilosec OTC will
help reduce costs and expand the availability of treatment options for millions
of Americans."
Unlike the two classes of currently marketed over-the-counter heartburn
treatments, antacids and acid reducers, Prilosec OTC is indicated for the
treatment of heartburn that occurs two or more days per week (frequent
heartburn). It stops acid production at its source in the stomach. Prescription
Prilosec is currently widely prescribed for frequent heartburn and other
related, but more serious, problems that need the care of a physician. Antacids
and acid reducers, which have long been available over-the-counter, are used for
the relief of acute heartburn symptoms. Acid reducers are additionally used for
the prevention of meal-induced heartburn.
According to the American College of Gastroenterology, over 60 million
Americans experience heartburn at least once a month and some studies have
suggested 15 million Americans experience heartburn daily. Heartburn occurs when
stomach contents containing acid back up and out of the stomach into the
esophagus causing a burning sensation in the chest or throat.
Prilosec OTC is a delayed-release 20mg tablet that must be taken before
eating once a day, every day for 14 days. Prilosec OTC may take one to four days
for full effect, although some consumers may get complete relief of symptoms
within 24 hours.
Prilosec OTC is not for people who have heartburn infrequently, one episode
of heartburn a week or less, or for those who want immediate relief of
heartburn. If frequent heartburn returns soon after 14 days of Prilosec OTC
treatment, consumers should contact their healthcare providers. Consumers should
not take a 14-day course of Prilosec OTC more often than every four months for
frequent heartburn unless directed by a doctor.
FDA based its approval of Prilosec OTC on the results of various studies,
including two clinical studies. These two clinical studies demonstrated that
Prilosec OTC was effective in increasing the proportion of patients with no
heartburn over 24 hours and that the effectiveness of Prilosec OTC increases
from Day 1 to Day 14.
Before using Prilosec OTC or any medicine, FDA advises consumers to read the
package label for complete information about the product's uses, warnings, and
directions.
Although side effects from Prilosec OTC are not common, they can occur and
may include: headache, diarrhea, constipation, upset stomach, vomiting, stomach
pain, cough, cold symptoms, dizziness and rash. Prescription Prilosec
(omeprazole), first approved by FDA in 1989, will remain available as a
prescription treatment for diseases that require diagnosis and supervision by a
doctor, such as Gastroesophageal Reflux Disease (GERD), inflammation of the
esophagus (esophagitis) and ulcers.
Because of the safety studies performed by the manufacturer of Prilosec OTC,
this product will have three years of over-the-counter exclusivity. Generic
versions of the prescription product will not be able to market an OTC version
until the marketing exclusivity has expired.
AstraZeneca LP of Wilmington, Del., and Procter and Gamble of Cincinnati,
Ohio, are the sponsors of the approved New Drug Application (NDA) for Prilosec
OTC.
For additional information, please visit the
GERD Center.
Source: FDA Talkpaper #P03-48, June 20, 2003
Last Editorial Review: 6/20/2003
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