FDA Says No Increased Risk of Cardiac Events From PPIs

WILMINGTON, Del. -- The US Food and Drug Administration (FDA) issued its final assessment of two small, open, long-term clinical studies in patients with gastroesophageal reflux disease (GERD), comparing anti-reflux surgery with either omeprazole (SOPRAN study) or NEXIUM® (LOTUS study) treatment.

AstraZeneca, which manufactures omeprazole under several brand names, 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 healthcare 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 Aug. 9, 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 U.S. in 1988 and in the U.S. in 1989. NEXIUM was first launched outside the U.S. in 2000 and in the U.S. 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.

Please see the full U.S. Prescribing Information for omeprazole at www.astrazeneca-us.com/pi/prilosec.pdf .

*Omeprazole is widely available as generic and OTC medication.
AstraZeneca trade names for omeprazole include LOSEC®, PRILOSEC®, Antra®, and Mopral®.

Source: AstraZeneca

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