Pharmacy Daily | Voltaren feels increased heat

NOVARTIS Australia has hit back at recent abstract presented by European Society of Cardiology which called into question the safety of diclofenac (Voltaren) saying it was associated with increased cardiovascular mortality and morbidity and should be used with caution in most individuals. The abstract is in part based on the findings of a recent Danish study into the safety of nonsteroidal anti-inflammatory drugs (NSAIDs) published in the journal Circulation: Cardiovascular Quality and Outcomes, which concluded that caution should be exercised when prescribing and administering diclofenac in “most individuals” due to an increased risk of cardiovascular mortality and morbidity. Responding to the abstract and the study Norvatis has said that “in the context of the extensive worldwide clinical experience with diclofenac, we do not believe this Danish study changes the benefit to risk assessment for diclofenac when used as directed”. “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,” a statement from the company said. As a result of the study and the stir it has caused, Norvartis is also hoping to stem concerns by advising patients to continue on with diclofenac as directed and to speak to their GP or pharmacist if they have any concerns. “Patient safety is of the utmost importance to Novartis,” the statement said. “Novartis maintains a robust drug safety monitoring process for all its medicines, the data from which is shared with the Therapeutic Goods Administration (TGA) on a regular basis. “[We] will continue to work with the TGA 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,” the statement concluded. MEANWHILE The Australian Self-Medication Industry has also added its voice to the debate, reassuring patients that nonsteroidal anti-inflammatory medicines play an important role in short term pain relief. Discussing the original Danish study, ASMI scientific affairs director, Steven Scarff said that it was important to note that the pain relievers examined were prescriptiononly (and hence were taken in higher dosages) and were supplied for longer periods (of around two weeks) than recommended for overthe- counter use. Scarff also noted that, as a historical review of medical record data, the study did not take into account patients’ pre-existing cardiovascular conditions or the presence of other cardiovascular risk factors. “NSAIDs are safe when used as directed, but like any medicine they can cause problems if used incorrectly,” Scarff said. As a point of interest Scarff also noted that the study found the use of low-dose ibuprofen and diclofenac was associated with a decrease in risk of cardiovascular death.

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