Patients who suffer from heartburn are not at increased risk for heart problems as a result of taking Prilosec or Nexium, according to a review released Monday by the U.S. Food and Drug Administration.
The FDA and Health Canada began reviewing the drugs, used by tens of millions of people, in May. The drug's manufacturer, AstraZeneca PLC, provided them with an early analysis of two small studies that suggested the possibility of a risk.
The American agency said its review of that study as well as 14 others indicated no increased risk for patients.
"FDA recommends that health-care providers continue to prescribe, and patients continue to use these products as prescribed," the agency said.
Health Canada says it is completing its analysis of the safety information for Losec and Nexium. "This review is targeted to be completed by mid-December 2007," spokesman Alastair Sinclair said in an e-mail. "Health Canada will advise Canadians of its conclusions and any resulting recommendations at that time."
The agency says patients with questions about Losec or Nexium should consult their doctor.
Nexium is the world's No. 2 selling drug, with 2006 sales of US$6.7 billion, according to health-care research firm IMS Health.
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