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Fdas safety reviews of prilosec and nexium find no proof increased rates of cardiac events
FDA STATEMENT

FOR IMMEDIATE RELEASE

December 10, 2007

Media Inquiries:

Rita Chappelle, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

Background: On May 29, 2007 AstraZeneca, the software creator of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) which were being treated with either Prilosec or Nexium. The studies specified for to assess great and bad treatment with Prilosec, or Nexium, or surgery for severe GERD. Participants were randomly allotted to receive treatment with whether drug (Prilosec in a single study and Nexium inside the other) or surgery. Throughout the studies, cardiovascular events raised a matter about whether long-term by using these drugs boosts the likelihood of strokes, heart failure, and heart-related sudden death in patients taking a single one with the pharmaceuticals compared to patients who received surgical treatment. On Aug. 9, 2007 FDA released an "Early Communication of the Ongoing Safety Review" of the drugs. The agencys initial review determined there wasn't any increased chance heart problems associated with long-term usage of these drugs. At FDAs request, AstraZeneca submitted a substantial amount of more info about these as well as other studies and FDA undertook an all-inclusive review of all available data regarding this potential safety concern. The following represents the agencys current analysis of accessible data on these medications.

Current Information: FDA has completed an all-inclusive, scientific report on known safety data for the drugs Prilosec and Nexium. While each the long-term studies reported to FDA on May 29, 2007 collected safety data, the analysis protocols wouldn't specify how cardiovascular illnesses, for instance cardiac arrest, were defined or verified. As an outcome, evaluating the info which was gathered in regards to the safety of both drugs over these studies was challenging. FDAs assessment in the information through the data gathered was further backed up by one more analysis of 14 comparative studies of Prilosec, four ones were placebo-controlled. Although these studies are not specifically conducted to assess the potential risk of heart disease, and patient follow-up was incomplete, they don't suggest a higher likelihood of heart related illnesses with the aid of Prilosec or its newer formulation Nexium.

Based on everything now known for the agency, the reported difference inside frequency of cardiac arrest as well as other heart-related problems affecting the previous analyses of the two small long-term studies won't indicate the use of an accurate effect. Therefore, FDA will continue to conclude that long-term using these drugs isn't likely to become connected with an increased risk of cardiovascular disease buy celexa online without a prescription. FDA recommends that health care providers always prescribe, and patients continue to use, the items as described inside the labeling for that two drugs.

About Prilosec and Nexium

Prilosec and Nexium are people a class of medication known as proton pump inhibitors (PPIs). Nexium (esomeprazole) is the newer formulation in the original Prilosec (omeprazole) product. As prescription products, one can use them to take care of the signs of GERD along with other conditions attributable to excess gastric acid buy levitra online. PPIs try to reduce the amount of acid produced in the stomach and help heal erosions from the lining in the esophagus called erosive esophagitis. They are also indicated to use by having an antibiotic to manage gastric ulcers. Prilosec is additionally available for an over-the-counter medication to treat frequent heartburn.

To read a summary of what FDA is aware of the details, visit:

www. fda. gov/cder/drug/early_comm/omeprazole_esomepazole_update. htm

To read the first Communication visit:

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

To report serious side 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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