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FDA STATEMENT

FOR IMMEDIATE RELEASE

December 10, 2007

Media Inquiries:

Rita Chappelle, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

FDA's Safety Reviews of Prilosec and Nexium Find No Proof Increased Rates of Cardiac Events

Background: On May
29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients
with severe gastroesophageal reflux disease (GERD) which are being treated with either Prilosec or Nexium. The studies were designed to
gauge the potency of treatment with Prilosec, or Nexium, or surgery for severe GERD. Participants were randomly used on receive
treatment with whether drug (Prilosec within a study and Nexium inside the other) or surgery. During the studies, cardiovascular events
raised a matter about whether long-term using these drugs raises the chance of cardiac arrest, heart failure, and heart-related sudden
death in patients taking both in the pharmaceuticals compared to patients who received surgical treatment. On Aug. 9, 2007 FDA
released an "Early Communication associated with an Ongoing Safety Review" these drugs. The agencys initial review determined there wasn't any
increased risk of heart problems linked to long-term utilization of these drugs. At FDAs request, AstraZeneca submitted a lot of
more information about these along with other studies and FDA undertook an intensive report on all available data regarding this
potential safety concern. The following represents the agencys current analysis of available data on these medications.

Current Information: FDA
has completed an extensive, scientific writeup on known safety data for your drugs Prilosec and Nexium. While both of the
long-term studies reported to FDA on May 29, 2007 collected safety data, the investigation protocols wouldn't specify how heart related
illnesses, for instance strokes, were defined or verified. As an outcome, evaluating the details that's gathered in regards to the
safety of both drugs over these studies was challenging. FDAs assessment on the information from your data gathered was further
based on a different analysis of 14 comparative studies of Prilosec, four ones were placebo-controlled. Although these studies were not
specifically conducted to gauge the potential risk of heart disease, and patient follow-up was incomplete, they do not suggest a
greater chance of cardiovascular illnesses if you use Prilosec or its newer formulation Nexium.

Based on everything now known
for the agency, the reported difference inside the frequency of heart attacks along with other heart-related problems observed in the
sooner analyses of these two small long-term studies won't indicate the existence of a real effect. Therefore, FDA is constantly
on the conclude that long-term usage of these drugs isn't likely being connected with an increased probability of cardiovascular disease.
FDA recommends that medical service providers continue to prescribe, and patients continue using, the products as described from the labeling
to the two drugs.

About Prilosec and Nexium

Prilosec and Nexium are individuals a class of medicine often known
as proton pump inhibitors (PPIs). Nexium (esomeprazole) is the newer formulation in the original Prilosec (omeprazole) product. As prescription products,
they are utilised to help remedy the signs and symptoms of GERD along with conditions caused by excess stomach acid.
PPIs try to slow up the level of acid made in the stomach and help heal erosions from the lining
from the esophagus referred to as erosive esophagitis. Fortunately they are indicated in order to use having an antibiotic to
help remedy gastric ulcers. Prilosec can be available for an over-the-counter medication to manage frequent heartburn.

To read an
index of what FDA knows about your data, visit:

www. fda. gov/cder/drug/early_comm/omeprazole_esomepazole_update order anexil online. htm

You just
read earlier Communication visit:

http://www. fda. gov/cder/drug/early_comm/omeprazole_esomeprazole. htm

To report serious negative effects visit:

www. fda. gov/medwatch/report/hcp. htm

/>

Or write to:

5600 Fishers Lane

Rockville, MD 20853-9787

Or Call: 1-800-FDA-1088

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