The US Food and Drug Administration has received and is reviewing new safety data about two popular heartburn medicines – Prilosec (omeprazole) and Nexium (esomeprazole).
AstraZeneca, the manufacturer of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA and other regulatory authorities world-wide their preliminary review of new 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 a drug (either omeprazole or esomeprazole) or to have surgery to control their GERD. The results from the study of Prilosec and analyses from an ongoing study of Nexium raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in those patients taking either one of the drugs compared to patients who received surgery.
Since May_29, the company AstraZeneca has provided FDA with a large amount of additional data, including more information on patient follow-up from the two long-term studies mentioned above, and pooled analyses of other controlled clinical studies, including placebo-controlled trials of up to two-year?s duration.
At this time, FDA?s preliminary conclusion is that collectively, these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of these products at this time.
This early communication is in keeping with FDA?s commitment to inform the public about its ongoing safety reviews of drugs. FDA plans to complete its review within three months, and will communicate its conclusions and any resulting recommendations to the public at that time.