FDA Sees No Heart Risk With Heartburn Drugs
Preliminary studies suggested possible problems with Prilosec and Nexium
FRIDAY, Aug. 10 (HealthDay News) -- 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 a Thursday afternoon press conference, Paul Seligman, M.D., 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.