Vioxx cousin is approved

On Nov. 7, 2006 Novartis announced that its painkiller Prexige had been approved by Health Canada for sale in that country. Prexige, like Vioxx and Bextra, is a COX-2 inhibitor – a family of drugs that has been linked to increased cardiovascular risks and other serious side effects. It is the first COX-2 inhibitor to be approved for use in Canada since Vioxx was removed from the shelves worldwide two years before.

Prexige is not available in the United States, though Novartis has submitted it to the Food and Drug Administration (FDA) for approval. But largely because of the difficulties experienced with Vioxx and Bextra, the FDA has recently made its testing guidelines more stringent, which has delayed approval pending further study into the drug’s effectiveness and relative safety. And unlike its Canadian counterpart, the FDA has much less authority to remove the drug from the market after approval should serious side effects become known.

However, Canada’s approval of Prexige means that many Americans will still have access to the drug through online purchases or by simply going to that country. Not only could this expose patients to similar cardiovascular risks as Vioxx and Bextra (or a host of other, as-of-yet unknown side effects), but they will not have the advantages of speaking with a doctor or accessing important safety risk information on the drug.

"Patients at risk of heart disease should avoid all selective COX-2 inhibitors, including Prexige, based on current evidence," wrote Dr. Garrett FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, in an e-mail to the Canadian Press (CP). Because of the way this class of drugs blocks pain, anyone with “high risk” factors like previous cardiovascular problems, obesity, and certain chronic conditions are more likely to experience a heart attack or stroke using COX-2 inhibitors.

Ultimately, it is the drug’s manufacturer who is responsible for the safety of the drug, no matter who gets the prescription or where they get it filled. But as many Vioxx trials are demonstrating, proving a direct link between COX-2 inhibitor use (for example Vioxx, Bextra, and Prexige) and cardiovascular problems is difficult to do on an individual basis. Most patients using these types of painkillers tend to be older, and therefore naturally more at risk for heart attack and stroke.

If you have experienced any serious side effects while taking Vioxx, Bextra, Prexige, or any other type of medication, contact Jim S. Adler & Associates to find out if the drug’s manufacturer may be at fault. We have over 30 years of medical law expertise, and we can help ensure that your rights are upheld. If necessary, we will take your case to court to secure a fair settlement to cover your added medical expenses, lost work, and pain and suffering. Call us directly to get a free case review, or fill in the form on this page.