Case Evaluation

Diclofenac: Common Painkiller Linked to Heart Attack

Common Painkiller Linked to Heart Attack

September 13, 2006

The safety of a common anti-inflammatory drug, Voltaren, is being reviewed because of concerns that it could pose the same risk of heart attack as Vioxx, which was withdrawn in 2004.

The Therapeutic Goods Administration said yesterday it was reviewing non-steroidal anti-inflammatory drugs, including the need for new warnings about diclofenac, an older drug sold over the counter under different brand names, including Voltaren.

Research by the University of Newcastle, published today in the Journal of the American Medical Association, finds that diclofenac can be harmful, even at commonly used doses. An analysis of 17 studies into the safety of the drug type found diclofenac increased the risk of cardiovascular "events" by 40 percent.

While the drug is most commonly sold as Voltaren in tablet form, it is known under many other names, including Clonac, Diclohexal and Fenac. Professor David Henry said the findings raised serious questions about diclofenac's safety and provided grounds for a review of its regulatory status. He would advise people with a history of heart problems against using it.

"Among the older drugs, diclofenac stands out as having a risk … equivalent to Vioxx, which was withdrawn in 2004. One reason … is that the drug is consumed in high doses and because we've had this drug for a long time the doses have crept up."

Professor Henry said doctors had always known diclofenac caused adverse effects such as liver problems and gastrointestinal bleeding, but the heart risks had been missed. He conceded it would be hard to voluntarily pull the drug off the market, as occurred with Vioxx, because there were many manufacturers instead of one and some products were sold over the counter.

A spokeswoman for Novartis Pharmaceuticals Australia, which makes Voltaren, said the company was reviewing the research. "As with all of our medications, we continuously monitor the safety of our products. Within the product information for Voltaren, it is stated that the dose should be individually adjusted and the lowest effective dose given for the shortest possible duration."

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