Vytorin Side Effects Potentially Riskier Than High Cholesterol

Chances are you've seen Vytorin commercials. They talk about two sources of cholesterol: food and family. Set to catchy background music, older folks portray family relatives offering pies, cakes and other cholesterol-inducing foods. All in all, the TV commercials are pretty cute.

You won't be seeing any Vytorin ads today. The drug manufacturers, Merck and Schering-Plough, suspended the advertisements after Congress raised questions about the cholesterol-reducing drug.

Results of a clinical trial called Enhance were released by Schering-Plough on January 14, 2008. The purpose of Enhance was to study the effectiveness of the drug. The study concluded in April 2006, and results were given to Merck.

Congress contends Merck was not pleased with the results of the study and remained silent for over a year. During this time, Vytorin racked up billions in sales. Under pressure by Congress, Merck released their results which showed the drug doesn't work. Many are speculating that Vytorin could turn into the next Vioxx scandal, while others are anxiously awaiting the fate of their medication.

Vytorin was approved by the Federal Drug Administration (FDA) in 2004 as a cholesterol-reducing medication. Manufactured and marketed jointly by Merck and Schering-Plough, Vytorin is a combination of cholesterol-lowering Zetia (ezetimibe) and the statin drug, Zocor (simvastatin).

According to Merck/Schering-Plough Pharmaceuticals, Zetia helps block absorption of cholesterol that comes from food. Zocor is said to reduce the risk of heart attack and stroke. Vytorin is marketed as a drug that can reduce plaque formation and thereby reduce the risk of heart attack.

Currently, more than 12 million Americans take Vytorin. While there are rumors the drug might be withdrawn from the market, it is still available by prescription. Whether you are currently taking the drug or considering taking it, Vytorin presents with a host of side effects that shouldn't be taken lightly.

Headaches are the most common Vytorin side effect. Nearly 7 percent of clinical trial participants reported an increase in the frequency and duration of headaches while taking the medication.

Muscle pain is the second most common side effect of Vytorin. It is also one of the most serious. According to the Journal of Clinical Investigation, statin drugs inhibit a key enzyme used in the synthesis of cholesterol. Scientists believe when this enzyme is not functioning properly, it can lead to a breakdown of muscle tissue. It's important to remember the heart is a muscle.

Medically known as myalgia, muscle pain was reported in 3.5 percent of clinical trial participants. The severity ranged from mild to intolerable and included muscle pain, tenderness and weakness.

Certain medications can increase the risk of muscle problems. The list is long and can be found at the Vytorin website. Included on the list are common antibiotics such as Erythromycin, Clarithromycin and Telithromycin. HIV protease inhibitors and the antidepressant, Nefazodone are included, as well as grapefruit juice and herbal remedies.

Other common Vytorin side effects include: overall feeling of weakness, indigestion, nausea, dizziness, unexplained rash, blurred vision, fatigue, abdominal pain, constipation, gas and diarrhea.

Rare side effects of Vytorin include itching, unexplained rash, swelling of the face, mouth, lips, tongue and/or throat, difficulty breathing, passing dark-colored urine, and yellowing (jaundice) of the skin or whites of eyes.

Vytorin should not be taken at all by individuals who drink substantial amounts of alcohol, women who are pregnant, plan to become pregnant or who are breastfeeding.

Statin drugs are known to increase liver enzyme production, therefore individuals who have acute liver disease or potential for liver disease should avoid Vytorin. Anyone starting treatment with Vytorin should undergo liver function blood tests before starting the medication and again several months later. Other liver problems that might be caused by Vytorin include hepatitis, jaundice, fatty liver disease, cirrhosis and Hepatoma, a type of liver cancer.

If you are currently taking Vytorin, consult with your physician before discontinuing or making dosage changes.

SOURCES:

http://www.vytorin.com/ezetimibe_simvastatin/vytorin/consumer/index.jsp
http://www.jci.org/117/12/3940?content_type=full
http://www.zocor.com/simvastatin/zocor/consumer/product_information/ppi/index.jsp
http://www.zetia.com/ezetimibe/zetia/consumer/index.jsp
http://www.fda.gov/bbs/topics/news/2004/NEW01138.html
http://www.sch-plough.com/schering_plough/news/release.jsp?releaseID=1095943