Monday 11th July 2005
An expert panel named by Health Canada states that Ibuprofen poses just as much risk of heart attacks and stroke as controversial painkillers like Vioxx. Ibuprofen is now one of the most commonly used painkillers, marketed since the 1950s and available without a prescription.
Vioxx was pulled from the market last year, in Canada and the U.S., because of the claims that it was responsible for many deaths. The Health Canada panel was asked to study Vioxx, Celebrex and Bextra, three painkillers known as Cox-2 inhibitors, but in the process, it came across the risks that Ibuprofen presents as well.
One of the conclusions of the report issued last Thursday was that Cox-2 inhibitors present the same increased risk of cardiovascular disease as traditional painkillers (non-steroidal anti-inflammatory drugs or NSAIDs), including ibuprofen.
Although panel experts admit that the benefits of these drugs outweigh their disadvantages, and that the risks presented by these drugs are extremely low for a healthy person, they warn that the risks increase with dosage and prolonged use, particularly for patients predisposed to cardiovascular problems and strongly recommend that patients should be given more information on labels and in package inserts.
As for ibuprofen, the panel?s recommendations include sale only after discussion with a pharmacist. The report states that it should be placed behind the counter and sold only upon request and after ensuring that "the risks of cardiovascular events are prominently displayed in materials that individuals receive at the time they purchase the drug."
In a separate recommendation, the panel called on Health Canada to make public all the information from all randomized trials of every drug it approves, "so that independent groups can go through that same information and come to their own conclusions about the benefits and harms of these drugs."
Health Canada spokesman Marc Berthiaume responded to these matters, explaining that firstly, Health Canada cannot place a drug behind the counter, as this is a provincial matter, and secondly, that even though current laws and trade agreements make it impossible to disclose all data on drugs proposed for marketing, the department is moving in that direction.
New labeling is being prepared by the department, for all the NSAIDs to reflect the latest information about their risks.
