A quarter of all heart attacks occurring in patients taking Merck's withdrawn painkiller Vioxx occurred within first two weeks of use, a Canadian study shows.
Merck - and indeed the US Food and Drug Administration - have taken the position that patients needed to be taking Vioxx (rofecoxib) for 18 months or more before the risk of heart attack was elevated.
This has been a pillar of the company's legal defense in court cases brought by people claiming their heart attack was caused by the product, and the latest study could provide encouragement and ammunition to lawyers who represent short-term users of the drug.
The study, led by Queen's University researcher Professor Linda Levesque, was conducted before Vioxx was voluntarily taken off the market on September 30, 2004, and examined the medical records of 239 people in Quebec who suffered a heart attack while taking Vioxx. It is the first study to specifically address the question of the timing of cardiovascular risk associated with COX-2 inhibitors.
The first two weeks' of treatment seemed correspond with the period of highest risk, and additional cardiovascular risk actually decreased with longer duration of use. The study also suggests that cardiovascular risk returns to normal within one month of stopping the drug.
"This demonstrates that cardiovascular risks from taking Vioxx may occur much earlier than previously believed," said Prof Levesque.
Insider's view: Oh dear! The city types will not be happy! Calculators out guys.
Hat Tip: PharmaTimes
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