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Senior Citizen Health & Medicine
Nexium, Prilosec Get OK from FDA After Quick Look at
Possible Heart Risk
Data do not suggest increased risk of heart
problems for patients
Aug. 9, 2007 Although still reviewing data
submitted by the manufacturer, the Food and Drug Administration today
gave a preliminary green light for the continued use of two acid
reflux treatment drugs popular with senior citizens - Prilosec (omeprazole)
and Nexium (esomeprazole). Nexium is the fourth leading drug in
world sales. FDA says the data do not suggest an increased risk of
heart problems for patients.
The agency recommends that healthcare providers and
patients should not change either their prescribing practices or their
use of these products at this time.
This early communication, the FDA says, is in
keeping with its commitment to inform the public about its ongoing
safety reviews of drugs. FDA plans to complete its review within three
months, and will communicate its conclusions and any resulting
recommendations to the public at that time.
On May 29, 2007, AstraZeneca, the manufacturer of
Prilosec and Nexium, sent FDA and other regulatory authorities
world-wide their preliminary review of new data from two small long-term
clinical studies in patients with severe gastroesophageal reflux disease
(GERD).
In both studies, patients were to be randomly
assigned to receive treatment with a drug (either omeprazole or
esomeprazole) or to have surgery to control their GERD.
The results from the study of Prilosec and analyses
from an ongoing study of Nexium raised concerns that long-term use of
Prilosec or Nexium may have increased the risk of heart attacks, heart
failure, and heart-related sudden death in those patients taking either
one of the drugs compared to patients who received surgery.
Since May 29, the company has provided FDA with a
large amount of additional data, including more information on patient
follow-up from the two long-term studies mentioned above, and pooled
analyses of other controlled clinical studies, including
placebo-controlled trials of up to two-years duration.
Based on everything we know now, said the agency,
FDAs preliminary conclusion is that the observed difference in risk of
heart attacks and other heart related problems seen in early analyses of
the two small long-term studies is not a true effect.
Prilosec and Nexium are members of a class of drugs
called proton pump inhibitors (PPIs) and work by reducing the amount of
acid produced by the stomach. Both drugs are used for the treatment of
gastroesophageal reflux disease (GERD) including a condition where the
lining of the esophagus wears away (erosions), and for maintenance of
healing erosions of the esophagus.
They are also used for the treatment of ulcers.
Prilosec (omeprazole) and Nexium (esomeprazole) are available by
prescription. Prilosec is also sold over-the-counter for frequent
heartburn.
The three drugs that lead Nexium in sales are the
cholesterol pill Lipitor (Pfizer Inc.), the asthma inhaler Advair (Glaxo)
and the blood thinner Plavix (Sanofi-Aventis SA and Bristol- Myers
Squibb Co.)
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