Ibuprofen risks similar to those of Vioxx, says Canadian panel of experts
Controversial drug Vioxx is as risky as the common painkiller Ibuprofen, a panel of expert panel set up by Health Canada has said. The former was pulled off the counters in Canada and the United States after its role in increasing cardiac risk in regular users was revealed.
Vioxx, a Cox 2 inhibitor, belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAID). Drugs like Bextra and Celebrax, belonging to the same group, were also pulled off along with Vioxx.
“The increased risk of cardiovascular disease caused by Cox-2 selective inhibitors seems similar to the increased risk associated with most NSAIDs,” a report released by the 13-member panel said, after going through data compiled by University of Oxford of 138 trials involving 144,296 patients, and ruling that NSAIDs carry the risk of health ailments like high blood pressure, inflammation and kidney disorders.
Developed in the 1990s, Cox-2 inhibitors became popular for providing pain relief without adverse effects on the stomach. They are especially popular among those suffering from arthritis.
Advocating the return of the drugs to the market, the panel said that the package of these NSAIDs should sport warning labels making the users aware about the health risk of taking these drugs, thus leaving the final decision to the users. Panel chairman Andreas Laupacis, the chief executive of the Institute for Clinical Evaluative Sciences in Toronto, added, “It’s a judgment call. There’s no drug that I know of that’s beneficial that doesn’t have some harms as well.” In the report, the panel added, “Health Canada should consider that ibuprofen only be sold after discussion with a pharmacist, and must ensure that the risks of cardiovascular events are prominently displayed in materials that individuals receive at the time they purchase the drug.”
Even though the panel lobbied for the return of Vioxx and Celebrax, it rated Bextra as the most dangerous and was in favor of a complete ban on the drug.
Responding to the panel’s findings, Canada health minister Ujjal Dosanjh said, “Health Canada supports the direction of the panel’s recommendations. I am not only impressed by the quality of the report, but also by the fact that the panel has made important suggestions that will further advance our plans for making important health and safety information more accessible.” He announced various initiatives following the panel’s findings, including those like directing NSAID manufacturers to provide updated patient safety information, conducting further analysis on ibuprofen and establishing standards for the risk and benefit information that must be included in product labeling of NSAIDs. “Health Canada’s initiatives will not stop there. The public can rest assured that Health Canada will continue to act in the best interests of protecting the health of Canadians. Health Canada will also follow up on other recommendations made by the panel,” Dosanjh added.
Vioxx, a Cox 2 inhibitor, belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAID). Drugs like Bextra and Celebrax, belonging to the same group, were also pulled off along with Vioxx.
“The increased risk of cardiovascular disease caused by Cox-2 selective inhibitors seems similar to the increased risk associated with most NSAIDs,” a report released by the 13-member panel said, after going through data compiled by University of Oxford of 138 trials involving 144,296 patients, and ruling that NSAIDs carry the risk of health ailments like high blood pressure, inflammation and kidney disorders.
Developed in the 1990s, Cox-2 inhibitors became popular for providing pain relief without adverse effects on the stomach. They are especially popular among those suffering from arthritis.
Advocating the return of the drugs to the market, the panel said that the package of these NSAIDs should sport warning labels making the users aware about the health risk of taking these drugs, thus leaving the final decision to the users. Panel chairman Andreas Laupacis, the chief executive of the Institute for Clinical Evaluative Sciences in Toronto, added, “It’s a judgment call. There’s no drug that I know of that’s beneficial that doesn’t have some harms as well.” In the report, the panel added, “Health Canada should consider that ibuprofen only be sold after discussion with a pharmacist, and must ensure that the risks of cardiovascular events are prominently displayed in materials that individuals receive at the time they purchase the drug.”
Even though the panel lobbied for the return of Vioxx and Celebrax, it rated Bextra as the most dangerous and was in favor of a complete ban on the drug.
Responding to the panel’s findings, Canada health minister Ujjal Dosanjh said, “Health Canada supports the direction of the panel’s recommendations. I am not only impressed by the quality of the report, but also by the fact that the panel has made important suggestions that will further advance our plans for making important health and safety information more accessible.” He announced various initiatives following the panel’s findings, including those like directing NSAID manufacturers to provide updated patient safety information, conducting further analysis on ibuprofen and establishing standards for the risk and benefit information that must be included in product labeling of NSAIDs. “Health Canada’s initiatives will not stop there. The public can rest assured that Health Canada will continue to act in the best interests of protecting the health of Canadians. Health Canada will also follow up on other recommendations made by the panel,” Dosanjh added.
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