FDA detects no risk

Ran on Friday, August 10, 2007

FDA detects no risk
Tests so far show Prilosec, Nexium don't cause heart problems

By the Associated Press and Leader-Telegram staff

WASHINGTON — The popular heartburn drugs Prilosec and Nexium do not appear to spur heart problems, according to preliminary results of U.S. and Canadian probes announced Thursday.
The U.S. Food and Drug Administration and its Canadian counterpart began reviewing the drugs, used by tens of millions of people in May. That is when the manufacturer, British-based AstraZeneca, provided them an early analysis of two small studies that suggested the possibility of a risk.
The FDA followed up on those studies and found that they seemed skewed: Patients who underwent surgery were younger and healthier than those treated by drugs, suggesting the heart link was a coincidence.
Dr. Jaime Zighelboim, a Luther Midelfort gastroenterologist, said the drugs are safe and have an excellent track record.
"I certainly concur with the FDA's current analysis of the published literature that there is no evidence linking these drugs with an increased risk of heart problems," Zighelboim said.
Those studies compared treating the chronic heartburn known as gastroesophageal reflux disease, or GERD, with either of the two drugs or with surgery, as well as tracked patients for five to 14 years. The company's initial analysis counted more patients treated with drugs who had had heart attacks, heart failure or heart-related sudden death.
While the studies' designs make safety assessments difficult, many of the participants who developed heart problems had risk factors before starting the drugs, Health Canada said Thursday.
The FDA then looked at 14 additional studies of the drugs and found no evidence of heart risks. In fact, in a few studies where patients received either medication or a dummy pill, those who took the heartburn drugs actually had a lower incidence of heart problems.
The FDA plans to complete its probe within three months, but issued a public notice Thursday that it "does not believe that health care providers or patients should change either their prescribing practices or their use of these products at this time."
Health Canada reached the same initial conclusion. It also urged doctors and patients to make no changes until its own probe is finished by year's end, noting that untreated GERD can lead to serious complications.
The drugs are among a family of acid-reducers known as proton pump inhibitors. FDA's Dr. Paul Seligman said Thursday that while the agency's focus is on Nexium and Prilosec, it is "interested in the data from all similar products" as it looks for all available evidence to settle the heart question.