CHICAGO (Reuters) – Drugmaker Merck & Co. on Wednesday gave preliminary results of a study of its
investigation of painkiller Arcoxia, the planned successor to Vioxx, which was pulled off the market in 2004 after being linked to stroke and heart attack.
Merck said the study, comparing Arcoxia with the anti-inflammatory drug diclofenac, found the “relative risk” of certain cardiovascular events was similar.
The incidence of patients withdrawing from the study due to side effects related to high blood pressure, edema and congestive heart failure was significantly higher for Arcoxia than for diclofenac, it said.
The U.S. Food and Drug Administration, rather than approve the Arcoxia outright, had sent Merck an “approvable letter” seeking more information on the drug.
Vioxx was pulled off the market in 2004 after findings that it doubled the risk of heart attack and stroke, leading Merck shares to sink and resulting in thousands of lawsuits against the company.