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Receiving FDA approval in 2002, Zetia is an anti-hyperlipidemic drug often used in conjunction with statins to control high cholesterol. Vytorin, taking this a step further, combines both medications in a single pill. Alone, Zetia works by preventing the small intestine from absorbing cholesterol and has been recommended when a statin alone won’t lower cholesterol levels. Yet, since this drug generically known as ezetimibe came on the market, patients have filed reports concerning related liver conditions, cardiomyopathy, heart attacks, and strokes.

Side Effects

When taken alone or with a statin, Zetia has been associated with several serious side effects:

  • Myopathy or muscle pain
  • Rhabdomyolysis, a degenerative disease that attacks skeletal muscle tissue. As this disease progresses, the lost tissue gathers in the patient’s blood, where it may cause kidney issues or death.
  • Various liver problems, including failure, stemming from heightened enzyme levels
  • Statin-related cardiomyopathy
  • Hepatic failure
  • Hepatitis
  • Acute pancreatitis
  • Thrombocytopenia
  • Cancer
  • Type II diabetes

Studies and Warnings

Medical professionals knew about Zetia’s defects as early as 2005. At the time, Health Canada issued a “Dear Doctor” letter about the drug’s side effects; however, the FDA failed to make such a motion against manufacturers Merck and Shering-Plough.

Roughly two years later, the New York Times reported that Merck and Schering-Plough conducted their own series of studies involving Zetia’s potential for liver damage when used long term with a statin. Yet, both decided not to publish the results, eventually known as the ENHANCE study and not released until 2008. During that time, both companies claimed Zetia, when combined with a statin, outperformed Merck’s older cholesterol drug Zocor. Once the results were out, neck artery imaging showed that Zetia and Vytorin performed comparably with the far-cheaper generic Zocor.

Adding to the damage, the companies only published the results after Congress started investigating the study’s two-year delay, during which the drugs brought in $5 billion annually.

As a measure to improve the medications’ reputations, Merck and Schering-Plough conducted and released a second study in 2015, called “IMProved Reduction of Outcomes: VYTORIN Efficacy International Trial” (IMPROVE-IT). Involving 18,000 patients, the study produced more favorable results this time, showing that Vytorin reduced total cardiovascular events by nine percent when compared with generic Zocor alone.

However, in response, the FDA forbid the companies from using these results in their marketing materials, instead stating that, compared to Zocor, Vytorin has no benefit, no matter how incremental, in reducing cardiovascular morbidity and mortality.

Outside of liver damage concerns, medical journal Archives of Internal Medicine identified a possible link between statin use and Type II diabetes in women. With the results published in 2012, researchers examined over 160,000 women between the ages of 50 and 79 years of age, and those who took statins had a 48-percent greater chance of developing diabetes. In response, the FDA required all statin manufacturers to update their warning labels.

In addition to these findings, other studies have identified a correlation between long-term and higher-dose Zetia usage and muscle issues. Specifically, seven percent of users taking the drug alone develop muscle problems, and once a statin is further involved, that figure jumps up to 10 percent. Eventually, the combination increases a patient’s risk of developing statin-related cardiomyopathy.

How does this occur? Researchers found that statins, including those combined with Zetia, activate the muscles’ atrogen-1 gene. In turn, it starts to degenerate muscle tissue, including cardiac muscles, and over time, this destruction manifests as heart failure.

Lawsuits

Sales for both medications have declined over the past decade, and multiple lawsuits may be to blame. In 2009, Merck and Schering-Plough settled several class action cases concerning the claims they made prior to the ENHANCE results’ release. Specifically, plaintiffs alleged Zetia and Vytorin are ineffective and unsafe, and as such, previous statements amount to consumer fraud. At the time, the company settled 145 lawsuits for $41.5 million in a federal New Jersey court.

As well, investors slammed the company, now known as Merck & Co., in 2013 over the delayed ENHANCE results. The plaintiffs involved in two lawsuits, which the company eventually settled for $688 million, claimed the company intentionally pushed the findings back to prevent a drop in sales.

Were you one of the many who took Zetia or Vytorin, only to develop a life-threatening or permanent and debilitating condition? Trantolo & Trantolo believes all patients have the right to accurate medical advice, and holds drug manufacturers accountable for obscuring crucial findings and harmful side effects. If you think you have a dangerous drug claim involving these two medications, reach out to our law office today to learn more.