COX-2 Inhibitors
Although COX-2 inhibitors (i.e., COX-2 selective NSAIDs) were developed for people who were at risk for developing gastrointestinal problems (including bleeding ulcers), COX-2 inhibitors didn't turn out to be more effective than traditional NSAIDs. The COX-2 drugs had the same side-effect profile as NSAIDs, as well as new side effects. With COX-2 inhibitors, especially when used at high doses, there was an increased risk for heart attack and stroke. After further study in this area, the FDA concluded that all NSAIDs (not just the COX-2 inhibitors) could increase the risk of heart attacks or strokes. Due to the reports of heart risk associated with COX-2 inhibitors, Merck & Co. (the maker of Vioxx) voluntarily removed the drug from the market on September 30, 2004.
Bextra was the next COX-2 inhibitor to be removed from the market, on April 7, 2005. The FDA requested the removal of Bextra based on insufficient information about its cardiovascular profile. Also, there were reports of serious skin rashes associated with Bextra (perhaps Stevens-Johnson syndrome). Ultimately, in light of the risks, the FDA felt Bextra had no advantage over traditional NSAIDs in terms of pain management.
Fact
During the fifth century B.C., Hippocrates used ground willow bark to relieve arthritis aches and pains — willow bark contains salicin. By 1897, German chemist Felix Hoffman developed a treatment for his father's arthritis which became known as aspirin, the first NSAID.
The only remaining COX-2 inhibitor on the market today is Celebrex. Why did Celebrex survive but not the other COX-2 inhibitors? According to the FDA, the benefits outweighed the risks for Celebrex, so the drug was allowed to remain on the market, but it came with some requests by the FDA:
Each Celebrex prescription was to include a patient warning regarding cardiovascular and gastrointestinal risks.
Patients and their doctors are encouraged to discuss the risks when Celebrex is prescribed.
Patients are advised to use the lowest effective dose of Celebrex and to use it only as long as needed.
The FDA requirements for disseminating information about risks was also added as a requirement for traditional NSAIDs, whether over-the-counter or prescribed, and changes were made to existing warning labels.
Thousands of people who took Vioxx, or who have a family member who took Vioxx, and subsequently suffered a heart attack or stroke are embroiled in a legal battle with Merck & Co. The Vioxx/Bextra debacle left arthritis patients worried and confused. Patients wondered how this could have happened. If the drugs were so unsafe, how did they ever make it to market? Most importantly, patients wondered what medications were left that were safe to take as an arthritis medication. Even though Celebrex was left on the market, patients didn't know what to trust or who to trust. Patients were encouraged, more than ever, to discuss their concerns with their doctor. Some patients stopped taking arthritis medications in search of a safer, natural treatment. Others felt comfortable sticking with Celebrex, while some patients reverted to older, traditional NSAIDs. Without question, the key is to be aware of any symptoms or side effects that seem out of the ordinary. Have routine blood tests if you take NSAIDs or COX-2 NSAIDs. Be vigilant and report anything suspicious to your doctor immediately.
