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Article: Nexium/Prilosec under review in Canada and USA after being linked to cardiac AEs.
- Article from:
- Pharma Marketletter
- Article date:
- August 20, 2007
CopyrightCOPYRIGHT 2007 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The US and Canadian drug regulators are reviewing new preliminary safety information regarding serious cardiac events in patients using Anglo-Swedish drug major AstraZeneca's off-patent Losec/Prilosec (omeprazole) and its follow-on drug Nexium (esomeprazole).
The two prescription drugs are used for acid-related stomach disorders, as well as to treat and prevent ulcers in the stomach and small intestine. Concerns were raised by 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 either of the two drugs or to have ...