December 22, 2004
British drug regulators have officially advised patients with heart disease to stop taking COX-2 inhibitors Bextra, Celebrex and Vioxx.
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued a "Dear Doctor" letter following a study last week that found an increased risk of heart attacks and strokes in patients taking high doses of Pfizer's Celebrex.
"Patients treated with any COX-2 inhibitor who have established ischaemic heart disease or cerebrovascular disease should be switched to alternative (non-COX-2 selective) treatments as soon as is convenient," the agency said.
The letter also reminds doctors that all nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, should be prescribed at the lowest effective dose for the shortest duration necessary. Other popular NSAIDs include naproxen, ibuprofen and aspirin.
"We are aware that new data from a clinical trial in the United States has indicated an increased cardiovascular risk (including heart attack and stroke) following treatment with celecoxib (Celebrex)," the agency said in a statement on its Web site.
"We have today issued a letter to healthcare professionals giving interim advice on prescribing of all COX-2 inhibitors, in light of emerging evidence, and have produced a question and answer document. Definitive advice will be issued, once further information is available and has been evaluated," it said.
"Patients receiving treatment with celecoxib (Celebrex) or other selective COX-2 inhibitors should not be alarmed and should make a non-urgent appointment with their GP to have their treatment reviewed," MHRA's statement concluded.
"For all patients, alternative treatments should be considered in light of an individual assessment of risks and benefits of COX-2 inhibitors, in particular cardiovascular, gastrointestinal and other risk factors," said Professor Gordon Duff, Chairman of the Committee on Safety of Medicines, the author of the letter.
MHRA noted that a recent letter to healthcare professionals from Pfizer, which highlighted the supposed cardiovascular safety of Celebrex, was "not authorised by the MHRA".
The latest Celebrex study, conducted by the US National Cancer Institute, found that the risk of heart attacks and strokes was 2.5 times higher in patients taking the 400-mg dose of the drug and 3.4 times higher with the 800-mg dose.
