The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom is the equivalent of the FDA in the U.S. A new study was reported by MHRA on March 1, 2006, regarding Celebrex. It lists a new study by several authors, including Dr. Brent Caldwell, citing a medical journal. The website summarized, stating the new study is based on data already assessed by regulatory agencies within Europe. The finding of the authors is entirely consistent with the conclusions of the former Committee on Safety of Medicines (CSM) and the European Medicines Agency (EMEA), which reviewed the cardiovascular safety of the selective Cox-2 Inhibitors in 2005. The new study provides evidence that the use of Celebrex is associated with an increased risk of heart attack when compared with the use of placebo or other non-steroidal anti-inflammatory drugs. Following the review in 2005, the European agencies issued updated advice to prescribers as follows:

• Selective Cox-2 inhibitors must not be used in patients with heart disease and/or stroke, patients with moderate-severe heart failure, or patients with peripheral arterial disease;

• Prescribers should exercise precaution when prescribing Cox-2 inhibitors to patient with risk factors for heart disease;

• The lowest effective dose should be used for the shortest necessary period. Periodic re-evaluation is recommended, especially for osteoarthritis patients who may only require intermittent treatment.

The study reveals that people taking Celebrex were at nearly twice the risk for heart attacks as those using rival treatments. As you most likely know, Celebrex, which is manufactured by Pfizer Inc., is the only Cox-2 inhibitor left on the market in the U.S. While Celebrex now has a black box warning – the strongest warning available, that really is inadequate considering the health risks involved.

The research reviewed six studies of 12,780 patients in an attempt to determine whether the increased risk of cardiovascular problems with Vioxx was also present with Celebrex. It found a 1.88-fold increased risk of heart attack when Celebrex compared with the other arthritis treatments. These results indicate that Celebrex® is similar in magnitude to Vioxx®’s risk of cardiovascular events. Dr. Richard Beasley, the Institute’s director, stated: “These findings are critical” because Celebrex’s risk is similar in magnitude to Vioxx’s risk. The research was published in the Journal of the Royal Society of Medicine. Dr. Beasley observed further: “Given the popularity of celecoxib (Celebrex) in the treatment of arthritis … drug regulatory authorities need to urgently re-examine the assessment of the drug in light of these findings.” He indicated further that this study’s findings concerning Celebrex® are consistent with a class effect of Cox-2 inhibitors increasing the risk of heart attacks.

Given the fact that Celebrex® is the only Cox-2 drug that remains on the market, the FDA should take steps to reexamine their assessment of this drug based on these findings. Celebrex will post sales of more than $2 billion in 2006, which is up from $1.7 billion in 2005. Last December, the U.S.-based Cleveland Clinic announced it would lead an international study to determine whether painkillers taken for arthritis, including Celebrex, Ibuprofen and Naproxen, are safe for those at risk of heart problems. That study is apparently underway. The latest study is available on the agency’s website at www.mhra.gov.uk/home.

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