FDA Concludes There Is No Increased Risk Of Cardiac Events For Patients Treated With Omeprazole And NEXIUM® (Esomeprazole Magnesium)
The US Food and Drug Administration (FDA) today issued its final assessment of two small, open, long-term, clinical studies in patients with gastro-esophageal reflux disease (GERD), comparing anti-reflux surgery with either omeprazole (SOPRAN study) or NEXIUM® (LOTUS study) treatment.
AstraZeneca agrees with the FDA conclusion which states “FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.” AstraZeneca also supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole and NEXIUM remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and NEXIUM.
The conclusion confirms the public announcement made on 9th August 2007 when the FDA stated that preliminary evaluation of the SOPRAN and LOTUS data does not suggest an increased risk of cardiac events for patients treated with omeprazole or NEXIUM. This announcement was in response to a communication sent to worldwide Health Authorities by AstraZeneca in May 2007 regarding the SOPRAN and LOTUS studies.
PRILOSEC®/LOSEC (omeprazole) was first launched outside the US in 1988 and in the US in 1989. NEXIUM was first launched outside the US in 2000 and in the US in 2001. Proton Pump Inhibitors (PPIs) have been shown to be beneficial for patients with gastroesophageal reflux disease (GERD). PPIs are generally well tolerated and PRILOSEC/LOSEC and NEXIUM have been used in the management of GERD in over 1 billion patient treatments.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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