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Aug. 9, 2007 -- The FDA today reported that so far, it has found no signs of heart risks associated with long-term use of the drugs Prilosec and Nexium.
Prilosec and Nexium belong to a class of drugs called proton pump inhibitors. They work by reducing the amount of acid produced by the stomach.
Both drugs are used to treat conditions including gastroesophageal reflux disease (GERD) and stomach and duodenal ulcers. Prilosec is also sold over the counter for frequent heartburn.
The FDA is conducting an ongoing review of new safety data on Prilosec and Nexium, which are made by the drug company AstraZeneca.
"The FDA has concluded preliminarily that these data do not suggest an increased risk of heart problems in patients treated with either of these products," the FDA's Paul Seligman, MD, MPH, told reporters today.
"At this time, we are recommending that health care providers and patients do not alter either their prescribing practices or taking of these drugs," says Seligman, who is the associate director of the Office of Safety Policy and Communication at the FDA's Center for Drug Evaluation and Research.
Seligman says the FDA has been in touch with regulators in the U.K, New Zealand, Australia, and Canada, who have reached similar conclusions about Prilosec and Nexium.
However, the FDA hasn't finished its review of the Prilosec and Nexium data. The FDA plans to complete its review within three months.
On May 29, AstraZeneca informed the FDA of early results from a long-term study of Prilosec and an analysis of an ongoing study on Nexium. Both studies included patients with severe GERD.
In the Prilosec study, which lasted for 14 years, patients took Prilosec or got surgery to treat their severe GERD. In the ongoing Nexium study, patients took Nexium or got surgery to treat their GERD.
"In these studies, AstraZeneca was attempting to ascertain whether drug therapy with either of these drugs or surgery was most effective in relieving and preventing recurrence of symptoms of severe GERD," says Seligman.
The data 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 those drugs, compared to patients who received surgery.
In the Prilosec study, more patients treated with Prilosec had heart attacks, heart failure, and heart-related sudden death than did the patients who had surgery. The difference between the two groups of patients was seen within the first year of the study, and continued over time.
In the ongoing Nexium study, initial data from this study suggested a difference between treatments in the rate of cardiovascular events. But an updated report submitted by AstraZeneca found that the number of patients who experienced heart problems was similar in both treatment groups.?
While both studies collected safety data, they didn't specify how heart problems, such as heart attacks, were to be defined or documented. As a result, the FDA says evaluating the information that has been gathered about the safety of either drug in these studies is difficult.
Since May 29, AstraZeneca has provided the FDA with a large amount of additional data from the two trials, along with pooled analyses of other studies.
At this point, the FDA's initial review of that data doesn't suggest an increased risk of heart problems for patients treated with Prilosec or Nexium.
Seligman notes that while the review isn't complete, the FDA issued today's statement as part of its commitment to inform health care providers and patients about emerging safety issues that affect public health.