Higher doses of Celebrex may increase risk of heart attacks and strokes

An analysis of studies involving Pfizer Inc.'s arthritis drug Celebrex showed higher doses of the drug were associated with an increasing risk of heart attacks and strokes.
The analysis, supported by the National Cancer Institute, broadly shows patients receiving the highest dose of Celebrex of 400 milligrams twice daily had a nearly three times higher risk of heart attacks and strokes than patients not taking the drug. Patients taking a lower dose of Celebrex, 400 milligrams once daily, had a 10% higher risk of a cardiovascular event.

In reality, most patients who are prescribed Celebrex – known generically as celecoxib – take a once-daily, 200-milligram dose of the drug, and that dose was not part of the analysis.

The full analysis is scheduled to be presented Monday at the American College of Cardiology's annual meeting.

"These data should provide some measure of comfort in prescribing celecoxib to patients with very low cardiovascular risk," Scott D. Solomon, the lead researcher and the director of noninvasive cardiology at Brigham and Women's Hospital in Boston, said in a statement.

He said the analysis backs recently issued practice guidelines that suggest doctors prescribe the lowest doses of Celebrex as possible and be cautious in using the drug in patients at high risk of having a heart attack or stroke.

Celebrex carries the Food and Drug Administration's strictest "black-box" warning on its drug label, stating that it may cause an increased risk of serious cardiovascular events such as heart attacks and strokes. A similar drug, Merck & Co.'s Vioxx, was taken off the market in 2004 after it was linked to a higher rate of heart attacks and strokes.

NCI then funded an analysis of six studies that lasted for at least three years comparing patients taking Celebrex to those taking placebo. The combined analysis involved 7,950 patients.

The analysis showed Celebrex was associated with an increased risk for a combined study endpoint of cardiovascular death, myocardial infarction (heart attack), stroke, heart failure or thromboembolic event, or events related to blood clots, compared to patients not taking the drug. The risk was not affected by aspirin use.

"Most of the data used in this pooled analysis have been previously published and are consistent with what we already know about the cardiovascular risks of Celebrex and other prescription arthritis pain relievers like naproxen and ibuprofen," Pfizer said in a statement. However, the company said it's important for arthritis patients to understand the risks and benefits of Celebrex.

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