FDA Sees No Heart Risk With Heartburn Drugs

THURSDAY Aug. 9, 2007 -- The popular heartburn drugs Prilosec and Nexium don't cause heart problems, U.S. health officials said Thursday.

The sudden announcement followed a government safety review after reports of a possible risk emerged from preliminary studies.

"After initial review and analysis of all the available data from the studies, the 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 U.S. Food and Drug Administration said in a prepared statement. "Therefore, health care providers or patients should not change either their prescribing practices or their use of these products at this time."

At at Thursday afternoon press conference, Dr. Paul Seligman, associate director of the FDA's Office of Safety Policy and Communication at the Center for Drug Evaluation and Research, said the agency "has concluded preliminarily that these data do not suggest an increased risk of heart problems in patients treated with either of these products.

"We have been in communication with our colleagues in the United Kingdom in New Zealand, Australia as well as Canada, and their independent review of similar data support our findings," he said.

Seligman noted that the FDA's review of the potential heart risks is ongoing. The full review is expected to be completed in about three months, he said.

Both drugs are made by the British pharmaceutical company AstraZeneca, which provided the data from the preliminary trials.

According to the FDA, the studies were designed to test the effectiveness of the drugs compared with surgery for severe gastroesophageal disease (GERD).

During the trials, some cardiac "events" were seen among study participants, and the findings were submitted to the FDA on May 29, the agency statement said.

Initial results of the Prilosec (omeprazole) study and data from an ongoing study of Nexium (esomeprazole) hinted that long-term use of both drugs could increase the risk of heart attacks, heart failure and heart-related sudden death in patients taking either drug, compared with those who underwent surgery, the FDA said.

Because of these concerns, the FDA was given more detailed data from the studies as well as findings from 14 other studies -- one 14 years in length -- that compared the drugs with a placebo.

The more-complete data showed that patients taking Prilosec had a lower risk of heart problems than patients taking a placebo, the FDA said. And findings from the ongoing Nexium trial found no difference in heart problems between patients taking the drug and those undergoing surgery.

"Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up is incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec. FDA will continue its review of all available data over the next three months," the agency said.

Prilosec and Nexium are drugs known as proton pump inhibitors. They treat the symptoms of GERD and other conditions caused by excess stomach acid.

According to a Bloomberg report, AstraZeneca reports that more than 1 billion patients worldwide take the drugs.

AstraZeneca, in a prepared statement released Thursday, said it "agrees with the FDA in their preliminary assessment that 'these data do not suggest an increased risk of heart problems for patients treated with omeprazole or esomeprazole' and that the observed differences in reported cardiac event rates in the two studies is not a true effect."

The statement added, "It is the view of AstraZeneca that the study results conclude that the products are not associated with an increased risk of cardiac events and do not change the overall benefit/risk profile of omeprazole and Nexium."

The company suggested that patients with questions about the drugs should discuss their treatment with their doctors.

Proton pump inhibitors decrease the amount of acid in the stomach and help heal erosions in the lining of the esophagus. They can also be given with antibiotics to treat gastric ulcers. Prilosec is also available over-the-counter to treat frequent heartburn.

More information

For more on GERD, visit the National Institute of Diabetes and Digestive and Kidney Diseases.

Posted: August 2007


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