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IMB Statement on Bextra

Apr 11, 2005 | Irish Health

The Irish Medicines Board has said it is advising doctors not to commence any new patients on the painkiller Bextra and is asking doctors to review patients already being treated with the drug with a view to changing their treatment.

The IMB says patients being treated with Bextra are advised to make an appointment with their doctor to discuss changing their current treatment.

Bextra's manufacturers, Pfizer, announced the withdrawal of the drug in recent days following concerns over reported side effects of serious skin reactions.

Some drugs in the class of drug to which Bextra belongs, Cox-2 inhibitors, has recently been associated with cardiac side effects, and another Cox-2 drug, Vioxx, was withdrawn from the market due to cardiac problems last year.

The IMN says its advice to doctors is being taken as a precautionary measure pending the finalisation of the assessment of the risk/benefit profile of Bextra, which is to be completed in around 10 days.

Pfizer decided to suspend the product after regulators in the United States expressed concern about the risk of serious skin reactions. The company said it had agreed to suspend sales in the US and Europe pending further discussions with the US regulatory authority, the FDA.

The IMB says the usage numbers of Bextra are considered low in Ireland, with about 3,000 patients currently being treated with the drug.

It says there is a range of other non-steroidal anti-inflammatory medicines available in the marketplace.

The IMB said the appropriateness of treatment can only be based on the doctor's assessment of the patient's medical history and current medical condition.

It says it is taking part in a EU-wide review of Bextra through its membership of the European Agency for the Evaluation of Medicinal Products (EMEA).


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