Attorney Ben Stewart: Vytorin “Controversial”

Whitehouse Station, NJWith a study about Vytorin expected in the next month or two, patients deciding whether or not to use the medication must rely on previous studies regarding Vytorin side effects. Those studies suggest that Vytorin can cause serious adverse reactions, according to Ben Stewart, attorney at Stewart Law, PLLC. Although there are no personal injury lawsuits currently working their way through the courts, that could change, depending on what the anticipated study shows.

“Vytorin has been controversial back to 2008, when the SEAS [Simvastatin and Ezetimibe in Aortic Stenosis] study suggested that it may cause higher rates of cancer,” Stewart says. “The FDA [Food and Drug Administration] has looked at Vytorin, requiring Merck to do several ongoing larger scale studies to determine the drug’s effectiveness and potential side effects and dangers.”

In addition to suggesting that Vytorin (a combination of simvastatin and ezetimibe) was linked to an increased risk of cancer, the SEAS study also suggested that the drug was no more effective than a placebo in reducing aortic valve and cardiovascular events. Based on these findings, it is possible that the benefits of Vytorin do not outweigh the potential risks.

“With any drug, the question we face is do the potential benefits merit the risks of the drug?” Stewart says. “Without a full understanding about the risks, patients cannot make informed decisions as to whether or not to take the drugs, and physicians cannot make a fully informed decision about whether or not to prescribe the drug. Vytorin has been linked to an increased risk of cancer, rhabdomylosis and liver damage. On January 9, 2012, the Archives of Internal Medicine published a study linking the potential risk of statin use in women and the development of type II diabetes."

Furthermore, according to Stewart, in February 2012, the FDA sent out a public notice that it was investigating whether simvastatin could cause memory loss in patients who used it for long-term drug therapy (two years or more).

“There has been some rattling about Vytorin’s ineffectiveness,” Stewart says. “If that is proven to be true, it changes the balance of benefits versus risks.”

There are currently no personal injury lawsuits alleging harm caused by Vytorin, but lawsuits were filed in 2009 alleging Merck and Schering-Plough withheld information about the risks associated with the medication. In August 2009, the companies agreed to pay a reported $45.1 million to settle approximately 140 lawsuits by consumers and insurers.

On February 14, 2013, Merck announced it would pay $688 million to settle a class-action lawsuit alleging the company misled investors by withholding the results of a study that suggested Vytorin was no better than Zocor alone at slowing atherosclerosis. In agreeing to the settlement, Merck did not admit to any wrongdoing.