The anti-cholesterol drug combination ezetimibe/simvastatin—sold under the brand names Vytorin and Inegy—has been proven to be less effective than advertised. It has also been linked to cancer, and one of its components, simvastatin, might cause muscle damage (including rhabdomyolysis), liver damage, diabetes, and memory loss.
What Is Vytorin? When Is It Prescribed?
Vytorin is the brand name for the drug combination of ezetimibe and simvastatin. Made and sold jointly by Merck & Co. and Schering-Plough, this prescription medication is used to treat dyslipidemia—excess cholesterol. Ezetimibe is known more commonly as Zetia in the United States and Ezetrol elsewhere; simvastatin is also sold separately as Zocor.
Ezetimibe was first approved for sale in the U.S. in the mid-2000s; simvastatin received its approval on December 23, 1991. Vytorin comes in the form of tablets to be taken orally. The ezetimibe dosage remains the same at 10mg, but the amount of simvastatin varies at 10mg, 20mg, 40mg, and 80mg. Vytorin entered the market some time in 2006. Vytorin sales have given its manufacturers $4-5 billion per year, though sales have been declining.
Both drugs affect users differently, and whether they are effective at all is the subject of much controversy. Ezetimibe supposedly prevents the small intestine from absorbing cholesterol. It has other indirect effects on cholesterol that prevent it from entering the blood plasma. Simvastatin is a statin-class of anti-cholesterol drugs that scientists first started exploring in the 1950s. Like all statins, simvastatin prevents the metabolic creation of cholesterol by blocking critical enzymes. By combining the two drugs in Vytorin, Merck and Schering-Plough believed they could both prevent the creation and absorption of cholesterol in the human body.
Vytorin Might Be Ineffective and Might Cause Cancer
On January 14, 2008, Merck and Schering-Plough publicly acknowledged that the “Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia” (ENHANCE) trial demonstrated that Vytorin was no more effective at reducing cholesterol than just the simvastatin found in Zocor was. By that time, however, Zocor was available as a generic drug because Merck’s patent on it had expired.
Moreover, Another trial, the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, showed a significantly higher incidence of cancer among patients who took Vytorin than among patients who took a placebo.
Without disclosing the ENHANCE test results, Merck and Schering-Plough continued advertising and selling Vytorin, and the House of Representatives Committee on Energy and Commerce began an inquiry into the delay.
Schering-Plough’s president, Carrie Smith Cox, was investigated for selling off 900,000 shares of the company ($28 million worth) between the time the ENHANCE trials were completed and the date the data was released. The Justice Department also began investigating Merck’s and Schering-Plough’s advertising for Vytorin.
Simvastatin Might Cause Additional Side Effects
High dosages of simvastatin are associated with a long list of side effects, the most serious and publicized of which are muscle disease (also known as “myopathy”) and kidney damage. The U.S. Food and Drug Administration (FDA) is also concerned that simvastatin might cause diabetes, liver injury, and memory loss.
Vytorin Side Effects Include Muscular Degeneration
In a June 2011 drug safety communication, the FDA instructed doctors to stop prescribing 80mg dosages of simvastatin. Research that had ended in 2010 and taken place over the course of seven years prompted the FDA’s warning. Known as the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), the study took the form of a randomized, double-blind clinical trial. Of the 24,747 patients treated with simvastatin in the SEARCH study, 0.03% of those taking a 20mg dose of simvastatin or its generic equivalent developed myopathy and 0.61% of those who took an 80mg dosage developed the disease.
Later, in March 2012, the FDA warned the public that simvastatin use combined with certain other drugs, namely “protease inhibitors” meant to treat HIV and hepatitis C, can raise the amount of simvastatin in users’ blood, which can cause myopathy. The FDA contraindicates using simvastatin with these drugs.
One of the more serious muscular diseases that is associated with simvastatin usage is rhabdomyolysis—a condition characterized by atrophying skeletal muscle tissue. The lost muscle tissue (myoglobin) collects in patients’ blood and can cause severe kidney problems or even death. Most of the time, this disease is caused by severe injury such as a muscle being crushed by an object, and in other cases it arises due to extreme alcohol abuse. Primary symptoms include:
The broken-down muscle mass can cause other problems throughout the body such as:
- electrolytic disturbances
- dark urine
- cardiac arrhythmia
- oligura or anuria (decreased or non-existent urine production, respectively)
- internal blood clotting
Treatment includes rapid rehydration, as most cases of rhabdomyolysis are caused by sudden incidents. Doctors might also prescribe various drugs to cause myoglobin to disintegrate. In extreme cases, they’ll put patients on dialysis.
Vytorin Might Be a Diabetes Risk Factor
On January 9, 2012, the medical journal, Archives of Internal Medicine, published a study analyzing a possible association between statin use in women and type 2 diabetes. The researchers investigated 161,808 women between the ages of 50 and 79 years old who participated in the Women’s Health Initiative over the course of several years. They found that women who took drugs belonging to the statin class were 48 percent more likely to develop type 2 diabetes than women who did not. The researchers concluded that “statin use is associated with an increased risk for [type 2 diabetes].”
In February 2012, the FDA changed simvastatin’s drug label to reflect the increased risk.
Vytorin Might Cause Liver Injury Side Effects
The FDA also determined that simvastatin has been associated with liver injury in rare instances. Symptoms of simvastatin liver injury include:
- unusual fatigue
- loss of appetite
- right upper abdominal discomfort
- dark urine
- yellowing of the skin or whites of the eyes
Vytorin Memory Loss Side Effects
Also in the February 2012 update, the FDA informed the public that it was investigating reports of simvastatin memory loss that occurred to users who had been on the drug for several years. Symptoms arose in every age group, though more often in patients over the age of 50. Examples are:
- memory loss
- “fuzzy” or unfocused thinking
RLG’s Lawyers Will Make Things Easier
Vytorin lawsuits against Merck and Schering-Plough are numerous.
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that getting satisfaction shouldn’t be just more hardship. That’s why we do everything we can to streamline the process, and we will file a Vytorin lawsuit on your behalf if necessary.
If you’ve taken Vytorin and believe it harmed you, contact RLG today for a free, confidential legal consultation..