Potential safety risks with Celebrex

Dec 20 2004

The Australian Therapeutic Goods Administration (TGA) has consulted today with the Chairs of its peak advisory committees, the Australian Adverse Drug Reactions Committee (ADRAC) and the Australian Drug Evaluation Committee (ADEC), about the latest research into the safety of the arthritis drug, Celebrex.

On Saturday the TGA received advice from its American counterpart, the US FDA, about some preliminary results from a long term research study using Celebrex that indicated there may be an increased risk of cardiovascular disease in people taking high doses of this drug.

The research was looking at a new use of Celebrex in preventing growth of colon polyps, and used up to twice the dose of the drug recommended for use in arthritis in Australia and four times the usual dose for which supply is provided in the PBS.

Since another arthritis drug in the same family, Vioxx, was withdrawn from the world market recently because of increased risks of cardiovascular disease, the TGA has been undertaking an exhaustive review of all Cox-2 Inhibitors, including Celebrex.

The TGA has now fast tracked this review requesting that the US research data be provided to the Australian regulator immediately and reinforcing to all other companies researching Cox-2 Inhibitors to produce their results as a matter of urgency.

The TGA has also instructed all organisations conducting trials using celecoxib not to enrol any further patients and to inform their ethics committees to formulate responses to existing trial participants.

In its December bulletin to doctors ADRAC warned medical practitioners who prescribed Celebrex for their patients to ensure they had appropriate information about the patient's medical history, especially in relation to existing cardiovascular disease. The Bulletin also informed doctors of the safety review being undertaken by the TGA in to Cox-2 Inhibitors.

Although there has been no evidence of a problem with Celebrex, the ADRAC had advised that all drugs in the class of Cox 2 inhibitors should be regarded as having an increased cardiovascular risk until more is known.