No Heart Risks Seen With Heartburn Meds

(AP)  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, back 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.

Those studies compared treating the chronic heartburn known as gastroesophageal reflux disease, or GERD, with either of the two drugs or with surgery, and 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.

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.

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.

Nexium is the world's No. 2 selling drug, with 2006 sales of $2.6 billion, according to health care research firm IMS Health.

[harp1963]

With sales in the billions of dollars, what kind of secondary results do you think the Republican appointed FDA was going to come up with. The Pharmaceutical Industry is the biggest financial supporter of the GOP, who appointed the operators of the FDA.

It's kind of like the Republican Big Oil Geologists who say that the polar ice caps aren't melting because of all the fossil fuel that is burning 24 hours a day 7 days a week around the world; it's just the normal climate cycle that is going to dry the earth up like a prune. It has nothing to do with that oil stuff that gave Exxon 9 billion dollars in profits during the first quarter of this year and is channeling billions of taxpayer dollars to Bechtel and Halliburton in Iraq to pump that stuff that isn't creating global warming, that isn't melting the polar ice caps. Naaah, it's all in our heads, oil smoke and fumes are good for our health, the Republican Geologists said so. It must be true since they are the moral party that praises Jesus all the time.