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Concerns that the painkiller Vioxx might cause an increased risk of strokes and heart attacks were first raised four years before the treatment was withdrawn by its manufacturers, it has been revealed.
The drug, primarily used to treat arthritis, was a commercial success when launched by Merck & Co in 1999, generating sales of £1.2bn a year.
It was pulled in September 2004 when a large trial found evidence to connect use of the treatment to potentially fatal cardiovascular problems, such as heart attack and strokes.
Speaking before a US Senate Finance Committee in November of that year, Merck’s then Chief Executive Raymond Gilmartin said research data had given the company no reason to believe people taking the drug were at an increased risk.
But new research has revealed that clear concerns were raised about Vioxx as early as December 2000.
Scientists writing in the journal Archives of Internal Medicine said data collected throughout June 2001 linked the drug to a 35% increased risk of a cardiovascular event or death.
The association was later strengthened as more data became available. As of April 2002, the analysis showed a 39% increased risk, and as of September 2004, a 43% increased risk.
Study leader Dr Joseph Ross, of the Mount Sinai School of Medicine in New York, said: “If we are to detect harms early and protect the public’s health, while ensuring the availability of new, clinically effective therapeutics, a system must be established that makes full use of all existing evidence.”
Copyright © Press Association 2009
Archives of Internal Medicine) 2009;169(21):1976-1985.
