Pharmacy Daily | NSAIDs under fire, again

A RECENT article in The Medical Journal of Australia has once again ignited debate over the safety profile of non-steroidal antiinflammatory drugs (NSAIDs). The article titled Stroke risk and NSAIDs: an Australian populationbased study, looked at the risk of stroke associated with nonsteroidal anti-inflammatory drug use, and found that patients prescribed with NSAIDs saw an associated increased risk of stroke. The study looked at 162,065 Australian veterans with incident dispensing of an NSAID between 01 Jan 2001 and 31 Dec 2008 and their rates of hospitalisation for stroke, ischaemic stroke or haemorrhagic stroke. According to the study the incident use of NSAIDs was associated with a 1.88 times increased risk of hospitalisation for stroke (ischaemic or haemorrhagic) following first ever dispensing of an NSAID. “Increased awareness of the potential for serious adverse cardiovascular events, together with individual assessment of cardiovascular risk, careful deliberation of the balance between risk and benefits and appropriate supervision, is required when initiating NSAID therapy,” the authors said. Aiming to alleviate concerns over Voltaren, Novartis issued a statement saying diclofenac therapies were not assessed in the study and that it is confident about the safety profile of the drugs. “Voltaren (diclofenac) medications are available worldwide and have been used by millions of patients for more than 30 years, making it one of the world’s most widely-used pain relieving and anti-inflammatory medicines,” the company said. “Medical evaluation of postmarketing data has not identified any new cardiovascular safety trend...The data reported in the Caughey study is in line with the known cardiovascular safety profile,” the statement added. In relation to the study itself Novartis was quick to point out that the authors stated “the analysis is associative only and does not prove causality”. MEANWHILE ASMI has also joined the chorus of NSAID defence, saying that current label warnings and existing advice regarding the non-prescription use of NSAIDs remains sound. “This study did not examine lower non-prescription doses or over-the-counter (OTC) use of NSAIDs, and was conducted in a very specific study population,” said ASMI Regulatory and Scientific Affairs Director, Steven Scarff. “Many of the veterans studied suffer from a range of medical conditions and will, on average, be prescribed 11 unique medicines in a year,” Scarff added. In addition, Scarff added that whilst the authors were unable to examine the OTC use of NSAIDs, they found no association between ibuprofen use and an increased risk of stroke in this specific population.

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