Two new studies each revealed troubling Vioxx safety data, putting pressure on Merck as the latest Vioxx trial is underway. One study linked Vioxx to an increase risk of kidney damage and cardiovascular events, while the other study confirmed the risk of heart problems began within the first 30 days of use of using the drug. Merck disputed the studies claims saying, “The observations in the JAMA articles and opinions expressed in an accompanying editorial regarding potential increased risks with short-term Vioxx use “are not supported by the current weight of clinical data.” These studies combined with Merck’s recent Vioxx trial loss, may make the company reconsider its decision not to seek a global settlement to resolve the thousands of cases pending against the company.
A study from Boston’s Brigham and Women’s Hospital and Harvard Medical School, which analyzed 114 studies involving more than 116,000 patients, showed that Vioxx “was associated with increased renal and (heart) arrhythmia risks.” Despite showing an increased rate of kidney problems, the study was unable to determine why the drug caused the damage.
The second report from the University of Newcastle, New South Wales, Australia, which reviewed 23 studies, confirmed findings of an increased risk of cardiovascular events associated with Vioxx, and found that these events could occur within the first 30 days of use. Merck has said that the cardiovascular risks associated with Vioxx only occurred after 18 months of use. In an editorial, Dr. David Graham of the FDA said the studies demonstrate that Vioxx “increases the risk of acute myocardial infarction at low and high doses” and that “there is no initial 18-month period of immunity from risk.”
Merck is facing more than 11,500 lawsuits on behalf of people claiming to have been injured after using Vioxx. Merck withdrew Vioxx from the market in September 2004 after a three-year study showed it doubled the risk of heart attack and strokes in patients taking it for at least 18 months. To date eight Vioxx trials have been completed with plaintiffs and Merck winning four each.