Vytorin is a drug prescribed to reduce the amount of cholesterol (a type of fat) in the body. The drug, originally approved in 2004, is a combination of Cholesterol-lowering drug, Zetia and the generic statin drug, Zocor. The drug was believed to benefit the patient by attacking both possible ways cholesterol can enter the body: through absorption in the intestine, and the body’s own production of cholesterol in the liver.
Cholesterol drugs are known to be the biggest moneymakers for the large pharmaceutical companies. Nearly 20 million American adults take some type of cholesterol-lowering medicine. Statins are the most common of these medications. Vytorin alone generates over $5 billion a year for Merck and Schering-Plough, co-makers of the drug.
Since its release in 2004, patients have reported serious side effects after taking Vytorin including heart attack, stroke, and liver damage.
ENHANCE Study Findings
Reports of side effects prompted Merck and Schering-Plough to conduct a study called ENHANCE. The endpoint or goal of the study was to indicate that Vytorin was more effective than Zocor alone. Results proved that Vytorin was no better than the older and less expensive generic, simvastatin (Zocor). The manufacturer waited TWO years, however, before releasing this result.
In addition to its two-year hesitation to release its findings, regulators found that the drug makers tried to change the ENHANCE study’s endpoint or main question that the study was meant to measure. Scientists generally maintain that the endpoint of a clinical trial must never change.
Later, Lawsuits would suggest that Merck and Schering-Plough waited two years to release the results because it would have had a negative impact on sales.
Additional Side Effects Of Vytorin
More studies have uncovered additional safety issues with the drug Vytorin. In 2010, the FDA warned of a rhabdomyolysis risk from the severe muscle damage in patients taking the highest approved dose of Zocor. Additional side effects include heart attack, stroke and severe liver damage.
Vytorin lowers low-density Lipoprotein, inhibiting the HMG-CoA reductase enzyme, causing myopathy and elevating liver enzymes.
Increased liver enzymes do not necessarily equate to a damaged liver. However, enzymes are often measured to see if a person has liver damage. If your liver enzymes are high, your doctor may continue to test them more frequently. An increase in liver enzymes can cause Hepatitis, Jaundice, Cirrhosis, and Hepatoma.
If you’ve taken Vytorin and experience nausea, vomiting, stomach pain, brown or dark-colored urine, yellowed skin, or lethargy, contact your healthcare provider. Your doctor will likely switch you to a different medication. When Vytorin is stopped, liver enzymes will likely return to normal levels.
Current Vytorin Regulations & Lawsuits
The FDA recommended in 2011 that Vytorin not be prescribed for new patients. Only current patients who have used the medication successfully with no sign of muscle injury should continue to take the drug.
Lawsuits allege that by the end of the ENHANCE trial, manufacturers knew that the drug was ineffective at reducing plaque from arteries. The lawsuit goes on to suggest that the companies purposefully kept that information from the public in order to keep sales high. Merck and Scherling-Plough (now a merged company) agreed to settle class-action lawsuits that claimed the drugs were unsafe, for $41.4 million. There are more than 140 claims pending in federal court in New Jersey, however, attorneys continue to evaluate Vytorin claims.
If you or a loved one has suffered liver damage or heart complications while taking Vytorin, please dial 314.444.4444 or email firstname.lastname@example.org. Schultz & Myers Personal Injury Lawyers offer free and confidential consultations.