alleged risk of heart attack and liver damage.
Vytorin Linked to Heart Attacks, Stroke and Liver Damage
However, a recent study called ENHANCE showed that Vytorin, which contains two types of statins, Zetia (ezetimibe) and Zocor (simvastatin), had no effect on the build-up of plaque in the arteries.
The goal of the ENHANCE study was to indicate that Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck. Instead, the study showed that, while both Vytorin and Zetia were found to have significantly reduced cholesterol in patients, neither drug provided any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries.
Anyone taking Vytorin who has had a cardiovascular event or clear evidence of clogged arteries may be at high risk. According to Allen Taylor, chief of cardiology at Walter Reed Army Medical Center in Washington, studies hint that Zetia might also “have some detrimental effect on the arteries”.
Plaque buildup is a major risk factor for heart attacks and stroke. Vytorin or Zetia were prescribed to people with high cholesterol on the assumption that the drugs would reduce this risk.
The American Heart Association says that the study looked at physical changes in artery walls, not at whether Vytorin did a better job of preventing heart attacks or deaths, and there won’t be conclusive reports until a large study is completed in 2011. "I don't think there's significant information to direct change," says AHA president Daniel Jones. (The AHA received nearly $2 million in contributions from Vytorin maker Merck/Schering-Plough last year.)
From The American Stroke Association:
Stroke warning signs:
- Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
- Sudden confusion, trouble speaking or understanding
- Sudden trouble seeing in one or both eyes
- Sudden trouble walking, dizziness, loss of balance or coordination
- Sudden, severe headache with no known cause
- Chest discomfort. Most heart attacks involve discomfort in the center of the chest that lasts more than a few minutes, or that goes away and comes back. It can feel like uncomfortable pressure, squeezing, fullness or pain.
- Discomfort in other areas of the upper body. Symptoms can include pain or discomfort in one or both arms, the back, neck, jaw or stomach.
- Shortness of breath with or without chest discomfort.
- Other signs may include breaking out in a cold sweat, nausea or lightheadedness
Another cause for concern is that Vytorin and other statins are known to increase levels of liver enzyme.
Vytorin, made by Merck and Schering-Plough, lowers low-density lipoprotein (LDL, or bad cholesterol). Statins, the largest family of cholesterol inhibitors and for the longest time the most potent, directly inhibit HMG-CoA reductase, the rate limiting enzyme of cholesterol synthesis. Inhibition can cause myopathy, a severe muscle wasting condition, and elevated liver enzymes.
Increased liver enzymes do not necessarily mean the liver is damaged. ( However, the statin drug Lipitor warns consumers on its package insert of “liver problems and adrenal insufficiency.”) Increases in liver enzymes occur in up to 3.6 percent of people taking Vytorin. This increase appears to be more prevalent in patients who are taking higher doses.
Liver enzymes are usually measured to see if a person has liver damage. If your liver enzyme levels are high, your doctor may continue to test them on a more frequent basis. They do not measure how well the liver is working. An increase in liver enzymes can cause the following:
- Hepatitis, which is an inflammation of the liver that can cause tiredness or a general feeling of illness
- Jaundice, or yellowing of the skin or eyes that can occur when the liver is damaged
- Fatty change in the liver
- Hepatoma, which is a type of liver cancer.
Several symptoms can occur in someone who develops liver problems while taking Vytorin. You should contact your healthcare provider if you have any of the following problems:
- Nausea or vomiting
- Stomach pain
- Passing brown or dark colored urine
- Skin or the whites of the eyes turn yellow
- Feeling more tired than usual.
Needless to say, the ENHANCE study has caused sales of Merck and Schering-Plough’s Vytorin to plummet.
According the most recent National Cholesterol Education guidelines, about 36 million Americans should be on some form of statin therapy. However, critics of the drug industry claim that these guidelines are biased toward drug therapy because a majority of the medical experts who drew up those suggestions have financial relationships with drug companies.
Meanwhile, Federal and state regulators are asking why results of the ENHANCE trial, which ended in April of 2006, were not released to the public until January 14, 2008. One lawsuit alleges that Merck and Schering-Plough knew at the end of the trial that Vytorin was ineffective at reducing artery clogging plaque, heart attacks and strokes, but purposely kept that information from the public and the medical community. It may also have known about liver damage.
Not only did Merck and Schering-Plough withhold the study results; according to the New York Times, the drug makers also tried to change the ENHANCE study’s endpoint. The endpoint is the main medical result the study was meant to measure, and it is generally accepted among scientists that for a clinical trial to be valid, the endpoint must never change.
If you are taking Vytorin and liver problems such as hepatitis, cirrhosis, or jaundice develop, your healthcare provider will likely switch you to a different medication. When Vytorin is stopped, in most cases, the liver enzymes return to pre-Vytorin levels.
If you or a loved one used Vytorin to reduce the risk of clogged arteries, heart attack and stroke, or if liver problems have developed while taking Vytorin, you may want to seek legal help.
Vytorin Heart Attack and Liver Damage Legal HelpIf you or a loved one has suffered liver damage or a heart attack while taking Vytorin, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Class Action Law Suits
Newsworthy Law Suits
Defective Products Lawsuits
Drug & Medical Claims Lawsuits
Food & Dietary Supplement Lawsuits
Personal Injury Lawsuits
Real Estate Lawsuits
Investment Fraud Lawsuits