Stroke risk with common pain killers dismissed by manufacturer

By Dr. Ananya Mandal, MDSep 14 2010

An eight-year Danish study, which involved more than 2.5 million healthy Danes found there was a higher risk of stroke for those taking high doses of ibuprofen, which is in the painkiller Nurofen. The manufacturers of Nurofen, Reckitt Benckiser, have dismissed these reports. The spokesperson for the company said, “it is important to note that the conclusions drawn by the study authors are based on high doses of ibuprofen…The results of this study should not be confused with non-prescription low doses of NSAIDs, such as ibuprofen, which are available over-the-counter and used by millions of people around the world, for short periods of time, every day.”

According to Dr Phil Berry, the company's global medical director there was “no clinical evidence to suggest that consumers need to be concerned about their safety in relation to an increased risk of cardiovascular events when taking non-prescription ibuprofen products.”

The findings of the study were presented to the European Society of Cardiology 2010 Congress in Stockholm, Sweden by Dr Gunnar Gislason last month. The study also explored diclofenac, marketed in New Zealand as Voltaren and its link with risk of stroke. Authors found that Voltaren increases the chance of those not thought to be at risk of suffering strokes by 86 per cent. The study authors concluded that care needed to be taken when patients were using non-steroidal anti-inflammatory drugs, in particular rofecoxib and diclofenac and over-the-counter sale of these drugs should be reassessed.

According to neurologist and stroke expert Professor Valery Feigin the painkillers should be banned. He said, “I would think these studies [would be] the last nail in the coffin for these types of medication…I seriously would not recommend this medication to anyone.”

A spokeswoman for Novartis, which makes Voltaren refuted the claims by saying the company was aware of the study but did not believe “it changes the benefit to risk assessment for diclofenac when used as directed.” She said, “Diclofenac should be used at the lowest possible dose for the shortest duration of time, in keeping with advice provided to prescribers in the approved product information…Novartis maintains a robust drug safety monitoring process for all its medicines, the data from which is shared with regulatory authorities on a regular basis. Novartis will continue to work with regulatory authorities to monitor and analyse research related to our medicines to ensure the information provided to both doctors and patients is consistent with current scientific knowledge.”

According to Ministry of Health senior adviser Susan Kenyon the risk was known and Medsafe recommended patients use the lowest effective dose of the drugs for the shortest possible time. Dr Kenyon said Ministry data showed heart attacks, rather than strokes, were a more likely complication from diclofenac and ibuprofen use. According to Ric Day, a professor of clinical pharmacology at the University of NSW and St Vincent's Hospital, said that while the study analyzed healthy people it was particularly relevant for people at risk of heart attack and stroke, such as those with diabetes or high blood pressure. “For people who are older and have these conditions there are significant risks,” he said. David Henry, the head of the Institute for Clinical Evaluative Sciences in Canada, and an adjunct professor at the University of Newcastle, said diclofenac had consistently been shown to pose the same heart attack risk as Vioxx and should be removed from the market. “There is no good reason why diclofenac should stay on the market but drug regulation authorities have not taken it on as an issue,” he said.

A spokeswoman for the Therapeutic Goods Administration said it had received eight reports of heart attacks and one of angina in patients taking diclofenac where a causal association was suspected. There had been none in patients taking ibuprofen.

Last financial year almost 656,000 prescriptions for higher strength Voltaren and 246,000 prescriptions of high-dose ibuprofen were covered under the pharmaceutical benefits scheme.