AstraZeneca Study Information Provided To Regulatory Agencies In May 2007 Currently The Subject of Their Ongoing Safety Reviews
(Posted by Tom Lamb at DrugInjuryWatch.com)
On August 9, 2007 the FDA and Health Canada issued email alerts about possible serious cardiac events in patients using the prescription heartburn drugs Nexium (esomeprazole) and Prilosec (omeprazole), made by AstraZeneca (AZN). These two drugs are prescribed for the treatment of gastroesophageal reflux disease (GERD), esophageal erosions, and for maintenance of healing erosions of the esophagus.
In more detail, the August 9 FDA alert about Nexium and Prilosec directed one to an online document entitled "Early Communication About an Ongoing Safety Review", which includes this introduction to a possible new drug safety issue:
FDA has received and is reviewing new safety data about Prilosec (omeprazole) and Nexium (esomeprazole). On May 29, 2007, 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.
This August 9 FDA document, however, went on to make this very important point:
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 [Prilosec] or [Nexium].
The August 9 Health Canada alert about Nexium and Prilosec directed one to an online document entitled "Health Canada reviewing new safety information on cardiac events in patients taking Losec (omeprazole) or Nexium (esomeprazole)".
As did the FDA, Health Canada made clear that it had not concluded there is a causal relationship between Nexium and Prilosec / Losec and this possible emerging drug safety issue:
At this point in time, Health Canada’s preliminary review suggests that the evidence provided does not confirm the existence of a possible cardiovascular risk. Health Canada will complete its analysis of the new information by the end of the year and will advise Canadians of its conclusions and any resulting recommendations at that time.
In Canada, omeprazole is also sold under the labels of Apo-omeprazole and Ratio-omeprazole.
If there proves to be an increased risk of heart attacks, heart failure, and heart-related sudden death associated with the use of Nexium, the ramifications would be significant due to this fact provided in an August 9, 2007 article, "FDA to Review Heartburn Drugs", published online by The Wall Street Journal:
AstraZeneca recorded $5.2 billion in Nexium sales last year. It was the second best-selling drug in the world behind Pfizer Inc.’s (PFE) Lipitor anti-cholesterol pill, according to IMS Health, a drug-data firm.
Last but not least, as advised by the August 9 Health Canada document, patients taking Nexium or Prilosec "should consult with their doctor before making any change to their medication, as GERD can lead to other complications, if left untreated."
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