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Celebrex in High Doses Linked to Higher Stroke, Heart Attack Risks

Apr 1, 2008 | Parker Waichman LLP Higher doses of Celebrex are a risky choice for patients with heart problems, a new study suggests.  The results of this latest Celebrex study, supported by the National Cancer Institute, indicate that doctors should use caution in prescribing the prescription pain reliever, and should use low doses when they use Celebrex to treat people at a high risk for heart problems.  

Celebrex belongs to a class of drugs known as COX-2 inhibitors and is the only such drug still on the market in the US. Blocking the COX-2 enzyme impedes the production of the chemical messengers (prostaglandins) that cause the pain and swelling of arthritis inflammation. COX-2 inhibitors have been linked to an increased risk of blood clots, heart attacks and strokes.  In 2004, another COX-2 inhibitor, Vioxx was removed from the market after studies linked it to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.  Another COX-2 inhibitor  called Bextra was also pulled from the US market due to safety concerns.

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.

The National Cancer Institute's Celebrex study consisted of a combined analysis of six studies of the Pfizer pain drug,  and included 7,950 patients.  According to The Wall Street Journal, the analysis showed Celebrex was associated with an increased risk of cardiovascular death, 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.

The researchers found that 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.

The study did not look at patients taking  a once-daily, 200-milligram dose of Celebrex, which represents the way the drug is most commonly prescribed.  Dr. Steven Nissen of the Cleveland Clinic, who has a study on lower doses underway, told Reuters that the conclusions that could be based on this latest Celebrex study were limited.  "There aren't long-term randomized placebo-controlled trials for that dose, The only way we're ever going to answer these questions is with good randomized prospective data," he said. "We'll tell it like it is when the data is in."

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