Healthy Skepticism Library item: 146

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Maher S.
Heart monitor on arthritis drug
The Australian 2004 Dec 21

Full text:

AUSTRALIA’S prescription drugs watchdog moved yesterday to curb clinical trials of an arthritis drug linked to an increased risk of heart problems.

In the wake of the concerns about Celebrex, the Therapeutic Goods Administration said yesterday it had ordered that no further patients be signed up to clinical trials.

It said organisations conducting trials should consult their ethics committees on how to deal with patients already involved in the trials.

The TGA also said it had fast-tracked a safety review of Celebrex in the wake of the research.

But the Australian Medical Association has called for the drug to be maintained on the Pharmaceutical Benefits Scheme, despite the concerns.

AMA president Bill Glasson said the drug still had “enormous benefits” for most users.

A new US study of the use of Celebrex in preventing colon polyps has shown that people who used between 400mg and 800mg of Celebrex daily had a 2 1/2 times higher risk of developing major heart problems. As a result, the manufacturer, Pfizer Inc, will stop promoting it to consumers. Dr Glasson said most users took only 100mg to 200mg daily.