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Potential safety risks with Celebrex

May 18, 2017

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Since another arthritis drug in the same family, Vioxx, was withdrawn from the world market recently because of increased risks of cardiovascular disease, the TGA has been undertaking an exhaustive review of all Cox-2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

tga.au

"Physicians or patients may think that the risk of cardiovascular disease in younger diabetic adults is too low to justify using aspirin. However, even without other cardiovascular disease risk factors, men and women 45 to 49 years old with diabetes have an estimated 7 percent 10-year risk of major cardiovascular disease events, a risk that is sufficient to justify the consideration of aspirin," they said.

Persell and Baker said aspirin may also be underused because many people with diabetes do not appreciate their cardiovascular disease risk, and although physicians understand the high cardiovascular disease risk associated with diabetes, they place greater importance on glucose control than on blood pressure management, cholesterol lowering or aspirin use as a means of reducing cardiovascular disease risk.

"Health professionals may have a large role to play in increasing appropriate aspirin use among adults with diabetes. Simple interventions such as offering professional advice about aspirin may be adequate to increase appropriate usage given that past studies have shown a strong association between current aspirin use and report of professional counseling," Persell said.

Health professionals are also in the position to help identify patients for whom the risk of aspirin may outweigh the benefits. Interventions that aim to increase professional counseling about aspirin for women, as well as young and middle-aged adults, may be especially helpful, the authors said.

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