Problematic Vioxx

 

 

 

 

 



Merck, the maker of Vioxx, the anti-inflammatory drug given to patients usually for the chronic pain associated with all types of Arthritis is under a class action lawsuit due to the elevated risks of heart problems. Merck was aware of problems with Vioxx for years before they withdrew Vioxx from the U.S. markets in the fall of 2004. The studies showing the risks of heart problems were deemed inconclusive. Merck was allowed to oversee the studies and make their own conclusions. Warnings were on the packaging but not given to physicians, caregivers or even patients as to the risks increasing as much as 40%. The higher risk numbers include large percentages that were fatal. Patients increased their risks of heart attack or even stroke the longer they were taking Vioxx.

According to a USA Today article October 12, 2004, as early as 2000 the FDA and Merck knew the drug had serious side affects and complications. During a 9 month study of 4000 patients they found the risks to be higher. That is 4 years that Merck was allowed to profit while the drug was still being prescribed to millions. According to Wikipedia, Merck had $2.5 million dollars in sales revenue in 2003. Merck fought the studies results saying the information and the percentages were not accurate. The FDA did not force Merck to pull the drug, Merck voluntarily removed the product. 

The reason Vioxx was allowed to stay on the market was due to the studies showing that Vioxx protected the stomach better than other drugs in its classification. Even after the studies showed the cardiovascular risks, Merck continued to amplify the gastrointestinal advantages. 

Even after the warnings, patients chose to continue using Vioxx. Vioxx allowed patients who were inactive and in excruciating pain to do everyday activities in significantly less pain. The patients have returned to their chronic pain level due to Vioxx being pulled. Patients had to weigh the benefits of Vioxx against the risks of cardiovascular problems which included death. Patients with no history or genetic predisposition found the risks minimal. Patients with a family history or personal history with heart problems stopped taking the drug. The relief from pain had not been eased before Vioxx or since. 

Vioxx belongs in the Cox-2 NSAID classification which stands for Non-Steroidal Anti-Inflammatory Drug. It is a Cox-2 inhibitor. Cox-2 is an enzyme that is found in tissue where there is pain and swelling. In normal tissue Cox-2 is not found.

 

 

 

 

 

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Barbara J Smart-Fisher

 

 

copyright 2008