Concerns about Zetia and Vytorin side effects are raised by data which suggests the drugs have limited benefits

Austin Kirk

By Austin Kirk
Posted January 15, 2008


According to a study released yesterday, the risk of Zetia and Vytorin side effects could outweigh the potential benefits for many users. Data from a clinical trial indicates that the cholesterol drugs do not provide any medical benefits for users when compared with high doses of generic Zocor, and they could possibly expose them to an increased risk of heart attacks and liver failure.

Zetia and Vytorin are popular drugs prescribed for treatment of high cholesterol. About 1 million people receive one of the drugs each week. Zetia, which is manufactured by Merck & Co. and Schering-Plough Corp., works by blocking the absorption of cholesterol in the digestive track. Vytorin is a combination drug made by the same companies, which contains both Zetia and Zocor. Approximately 60 percent of those who take Zetia receive it as part of the Vytorin combination drug.

The study, known as Enhance, found that Zetia and Vytorin side effects caused fatty plaques which develop in arteries to build nearly twice as fast when compared with individuals who received Zocor alone. The clinical trial followed about 720 individuals with very high cholesterol for two years. Users of Vytorin and Zetia were found to be more likely to die or suffer cardiac complications according to the data, but given the limited nature of the trial, the results did not reach the level of statistical significance. This means that the differences could have been caused by chance. Larger studies are needed to better evaluate the nature of the risk.

An article last month in the New York Times also raised concerns that Zetia and Vytorin side effects may increase the risk of liver failure and drug-induced hepaititis when taken in combination with statin cholesterol drugs. Speculation about the Zetia liver damage risk were raised after a spokesmen for the drug makers acknowledged that several patients were removed from the Enhance study after testing indicated that they had elevated liver enzymes.

Statins, which include drugs such as Lipitor, Crestor and Zocor, are often prescribed with Zetia or as part of the Vytorin pill, which combines Zetia and Zocor. According to the New York Times, there have been several reports of severe liver damage associated with the use of Zetia and statins, and the combination has been shown to cause liver damage in animals.

The results of the Enhance study were described as “shocking” by Dr. Steven Nissen, the chairman of cardiology at the Cleveland Clinic, who authored a study earlier this year about the risk of Avandia heart attack side effects. Dr. Nissen was also one of the first doctors to raise questions about Vioxx, which was recalled in 2004.

Dr. Nisson suggested that Zetia and Vytorin should not be prescribed unless all other cholesterol drugs have failed to work, as the drug has no benefits and may expose individuals to an increased risk of heart attacks. The FDA has not yet commented on the data, but no decisions should be made about whether to stop taking a drug without first consulting with a your physician.

The lawyers at Saiontz & Kirk, P.A. are closely reviewing information about the potential Zetia and Vytorin side effects, and whether adequate information has been provided about the risks and benefits of the drugs. If you, a friend or family member have suffered a heart attack or liver failure after taking Zetia or Vytorin, you can review the legal options which may be available by requesting a free consultation.

33 Comments • Add Your Comments

  • James Turpin says:

    I have been on Vytorin for a couple of years, Lipitor before Vytorin. I had abdominal aneurysm surgery in June 2007. It was extremely large, I had to be intubated for 4 days as the surgery took so long my lungs filled with fluid. Anyway, I have had heart caths during the past few years and not once was any aneurysm noted. So I can’t help but wonder if the plaque builds up twice as fast with this medication could that have been the cause of how quickly it seemed to develop. Plaque doesn’t just build up in the heart but any of your arteries.

    Posted on January 16, 2008 at 1:58 am

  • Roxanna says:

    I am trying to find the site where I read about a woman who was having arm pain due to vytorin. The response said she had recently moved and thought the pain was from that. A naturalist said because it was one arm and not both or other areas, it probably was not due to vytorin. If you know who or can find this, or you are her, please reply.
    Thank you.

    Posted on January 17, 2008 at 12:45 pm

  • Bill Ellis says:

    I stopped taking Vytorin about a month ago; was on it for about two years. Reason I stopped is to see if the chronic pain in my shoulder, arm and elbow [over a year] was a side effect of the drug. Pain is subsiding and I’ve read that it usually takes about two months to heal if it was a drug side effect. Now I read the above information on Monday and wonder if the drug might have caused an onset of heart disease. Have come to the conclusion that mildly elevated cholesterol is not as much of a problem as the treatments.

    Posted on January 17, 2008 at 2:03 pm

  • Truman Motter says:

    I heard the news about Vytorin not being effective and actually causing plaque build up in the arteries and I quit. I complained to my doctors about the pains that I was suffering and because of my age it was past as probably arteritis. I must tell you the doctor prescribed pain medication. When I quit taking the Vytorin my pains went away and so I stopped the pain medication as well. I also started to take the amino acid EDTA which has helped me alot and now I don’t need to take fiber supplements and am feeling great. You can do a serch for EDTA on the net and read the information. I am so thankful for all of this and NO VYTORIN!

    Posted on February 4, 2008 at 10:37 am

  • Eva says:

    I have been on one of these statins for the last several years Zocar, Lipitor, Vytorin. For over a year now I have suffered from right arm and shoulder pain. Also my left ankle along the tendon is extremely painful to point that I can not walk very far from the pain. I stopped taking any of drugs about 2 months ago because of the pain and reading that it was from the drugs. Is there anything else that I might could do for these pain. Or is it something I am going to have to live with it for the rest of my life?

    Posted on February 5, 2008 at 9:30 pm

  • maryannesakihara says:

    My husband has been having off and on memory problems,he can’t remember ,since he was raised to 20 mils. of lipitor.However his cholesteral has gotten higher on 10 mil.I was going to ask the Dr. to give him Zetia,to give his liver a rest,but now i here about problems with Zetia.Now i just split his Lipitor in half and give him Q-10 and the vitamin over the counter,that lowers cholesteral,and fruits and veggies more.

    Posted on February 8, 2008 at 4:28 pm

  • Susan says:

    I took Vytorin for 4 months and started having nightly charley horses in my legs. When I spoke with my pharmacist he stated this is strictly off the record but stop taking and contact Doctor as Vytorin can cause kidney damage. After I discontinued charley horses went away, and I now take fish oil and red garlic yeast, and my cholesterol numbers have improved dramatically.

    Posted on February 10, 2008 at 8:04 pm

  • Becky says:

    While taking Vytorin, I have been diagnosed with a fatty liver and I have right upper quadrant pain. My gastroenterologist said that this is from the fatty liver. I, too have right shoulder pain. When I go and have the liver function tests, they show to be in normal range.

    Posted on February 16, 2008 at 2:49 am

  • Lynne says:

    My husband took 2 10mg tablets of zetia. Withing hours he had severe arm pain and heartburn. The next day his urine was darker than listerine and foamy like beer. He took his second dose the next day not realizing these problems were with the zetia. All of the above symptoms were still there but then his stools turned white!!!!! After a week of him saying he was alright I decided to take him the the doctor. He was told to immediately discontinue them, which he had days before and then sent to the hospital for bloodwork. He was immediatly admitted to the hospital with an initial diagnosis of drug induced hepatitis!! He had ultra sounds, cat scans, mri and numerous blood tests. He was hooked up to fluids and during the course of 5 days he had approximately 20 plus bags of fluid. Drs were concerned that his liver enzymes kept continuing to rise despite all the fluids and restricted diet and no other meds except his bloodpressure meds and a pill for itching, since his billirubin was high which made him itch since his body was not absorbing the nutrients. This medicind is POISON. DO NOT TAKE IT. The pharmaceutial company should be shut down for producing a product like this. Who knows, this POISON may have shortened his lifespan.

    Posted on March 14, 2008 at 8:11 pm

  • Harriet says:

    I was on Zetia from March, 2005 until Jan., 2008. During that time I had extreme muscle pain, increased liver enzymes, pancreatitis, irritability and severe memory loss. I could not walk more than 500 ft. without pain. My cardiologist repeatedly stated it was not the medications (he was wrong). Because the muscle pain was so extreme, my life ended during those years. I was unable to do anything other than rock with pain. I had numerous nerve conduction tests, MRIs, PAD test, etc. before I knew it was muscle damage (mylagia) due to Zetia. My muscles were so weak, I had to move my bedroom downstairs (at great expense)as I was unable to go up or down steps. My legs were giving out from under me and I had many falls and, now lifetime, injuries as a result.
    During this time period I also developed many additional arrythmias which is noted as a side effect of Zetia (Rhabdomplysis).
    I had extreme episodes of gastritis (or pancreatitis) and underwent many gastro tests.
    When I stopped the Zetia all the pain left, the gastritis (or pancreatitis) left, my memory improved. I was able to walk distances and was able to go up and down steps. I still have permanent damages in my knee, ankle and toe from numerous falls.
    I agree with letters on this site that say this medication is poison to some people. I am very angry that Sherling-Plough values money more than people.
    I want to be part of a class action lawsuit again Zetia and I am looking for a law firm to represent me. Anyone know of a class action suit based on the side effects of Zetia?

    Posted on March 18, 2008 at 8:25 pm

  • sheila says:

    i was on zetia for approx. 3 yrs. i ended up having two blocked arteries going into both kidneys, i had to have angioplasty and stences put in the arteries, i can’t find any law firm that will represent me…so i feel the drug company has gotten away with injuring me, and because my blood pressure became so high from the blocked arteries, my kidneys are more than likely damaged.

    Posted on June 1, 2008 at 12:08 am

  • Joanne says:

    I have been taking Vytorin for about four months now and recently (about the past six weeks) have been having Charlie Horses almost every night and often during the day. I will be contacting my doctor tomorrow as my pharmacist told me today that Vytorin could be the cause and it could also cause heart muscle weakness and heart damage. How can the pharmacists sell these drugs if they are so damaging to so many people?

    Posted on June 1, 2008 at 4:05 pm

  • Debbie says:

    I was put on Vytorin last June for a 2 week period. In just that short time, I had a kidney infection and felt that I was run over by a MAC truck. I discovered that these were the worst side effects of Vytorin you could have. To this day I still have alot of muscle soreness and weakness. We are now the testing animals.

    Posted on August 11, 2008 at 7:36 pm

  • dorothy says:

    on zetia for about two years. Having muscle weakness, legs and arms, nervous feeling, slight shortness of breath and just a funny feeling that goes through my body just as these symptoms are happening. I’m off the med now for several days. How long does it take for zetia to leave your system? also my memory is not as good and I’m more irritable.

    Posted on December 17, 2008 at 8:17 pm

  • otis says:

    i,ve been takeing the drug called zetia 10 mg. And now iam hurting in my lungs and my joints.Legs, And i feel funnie to just how long does it take for this zetia to leave your body.I hurt real bad in both of my sides.

    Posted on April 23, 2009 at 3:25 am

  • Heather says:

    I have RA and take a med for that..,works great. Then my Dr gave me Zetia, I have been in severe pain ever since…my legs from my hip to my ankles feel as if someone is trying to rip them apart. Called my Dr and told them I am stopping this Zetia med but am needing to see her for the pain is unbearable. I have 2 infants at home with me and can’t believe this is on the market, for one should be able to take a med and not have to worry like this. Hopefully by next week when I see my Dr, the pain will have stopped, because I do not take pain meds and I will go through testing to find out what damage this med Zetia has caused.

    Posted on May 12, 2009 at 8:00 am

  • pam says:

    has anyone had an increase in sugar levels? I have been diagnosed with type 2 diabetes and went for a glucose tolerance test today and it couldn’t be completed since my sugar level was so high and I was fasting. This doesn’t make sense. I eat healthy and exercise.

    Posted on May 18, 2009 at 12:03 pm

  • Tammie says:

    I have been on vytorin for 2 years . I have severe leg pain and knee pain. I can hardly get up and down the stairs. I told my doc about my pain and he just sends me to anothe doc or pt.My doc looks at me like iam crazy when I complain about my leg pain. I just finally started thinking it was the vytorin. I realize after looking around on the web , it is. Iam going to stop taking vytorin. I will tell my doc when I go back in july.

    Posted on May 30, 2009 at 8:44 am

  • M Miller says:

    I suffered from Transient Global Amnesia about a year ago. I truly believe that it was a result of the Li;pitor that I was taking. My doctors continue to believe that I should take this drug. I have been off this for about a year with no further problems. For the last 6 months I have been taking 2 1000 mg Flush Free Niacin,in the AM and PM. however, after new blood work, My total cholesterol is still 223, it was 224 without Niacin. I have also lost 20 pounds in attempt to help lower my numbers. HDL too low, LDL to high.

    THey now want to put me on Zetia, but I am really afraid of these drugs, even though this is not a statin.

    I just read that Flush Free Niacin is no good and you should take the real Niacian.

    Posted on July 3, 2009 at 9:52 pm

  • J Ford says:

    I have been on Vytorin for almost 2 and a half years. A week ago I saw my cardiologist and he had blood drawn for a check of my cholesterol. Although, I didn’t know it, he had a muscle test taken because I was complaining about being very week and aching all over. I have felt weak for a long time but attributed it to age, I am 66, and maybe having arthritis. On this past Friday, my cardiologist’s nurse called and told me to stop taking the Vytorin. The muscle test showed that the Vytorin was making every muscle in my body weak. Those were her exact words. Today, I received a form for another blood test to be taken in a couple of weeks. I called and asked what the test was for and was told it was to see if I have had a heart attack. I had complained to the cardiologist of angina and chest pain and soreness when I touched my upper ribs in my chest. I have been off the vytorin for 5 days but I am feeling just as weak even though the nurse said I should start to feel better after I stopped the vytorin. Now, I am afraid tht I may have had a third heart attack and that the weakness and pain from the Vytorin may be permanent. If the Vytorin has had such a negative effect on my life, I wonder what, if any, legal recourse I have against the drug company.

    Posted on November 11, 2009 at 4:08 am

  • ALVENA says:

    I have been on VYTORIN 10/20 for about 2 years, Ihave been expierenceing muscle pain in my legs and my arms legs knees and all over my hold body it has been rough.

    Posted on November 25, 2009 at 1:47 am

  • Karin says:

    After reading some of the comments on Zetia, I am beginning to think that my problems are related to this drug. I have been on Zetia for over 2 years and my legs hurt so bad, I have shortness of breath and can’t exert myself at all, heart starts pounding. I am weak and have funny feelings thoughout my head and especially when I go to sleep. I wake up choking from my sleep when I drift off for a few minutes. I have been to the ER twice and once the EKG was abnormal. I currently cannot work due to exhaustion and can’t get the right words out of my mouth. In the past when I have tried various statins, my legs would hurt almost instantly, but this time it took a while.

    Posted on December 16, 2009 at 6:13 pm

  • Tom says:

    I am terrifyed after doing some recent research on Zetia. After having CABG at age 41 my cardiologist placed me on a statin to control hyperlipidemia and soon after I became so stiff and robitic, I could barely move so it was determined that I was allergic to statins and I was placed on Zetia which was perported to be similar to the statins but much safer and without the muscular side effects, and now after my research I feel I have been lied to! I have been taking Zetia for over five years now and about 2 years ago I began having myalgia and thought I was getting RA and went to a rhumatologist who did tests and found that I had moderately elevated CPK levels but not high enough to diagnose me with RA or fibromyalgia. Now this past september I was lifting an item weighing approximately 63 pounds and suddenly my right biceps tendon ruptured and my bicep recoiled up to my shoulder which required surgery to reattach and yet my other muscles increasingly ache.I am so afraid of more things snapping off of me. some times I feel so week and stiff that I cant moove. The makers of this poison should be brought to justice and made to make us whole again.

    Posted on January 4, 2011 at 7:08 am

  • Susan says:

    I had to quit taking vytorin because it was causing my kidneys to fail, January 1st,2012

    Posted on April 4, 2012 at 7:09 pm

  • JAMES says:

    I stopped taking Vytorin in July of 2012 after going into Acute Renal Failure with a Creatinine of 2.2 (normal is 1.3 or less). My Glomerular Filtration Rate dropped to 32%. 3 weeks after discontinuing Vytorin, my Creatinine dropped to 1.6 & GFR improved to 47%. Vytorin was destroying my kidneys and killing me.

    Posted on March 1, 2013 at 11:24 pm

  • Pam says:

    This is the second time I have been on Zetia. This time for a little over a year. I have severe pain in my hips, some days I can hardly walk and I never get any sleep due to the pain. Also at times have shortness of breath. I have quit taking it as of this week and hoping the pain will go away and that I don’t have any permanent damage. I notice that my CPK has been high but did not know it could be from the Zetia. SO hopefully since I am stopping it the pain will go away and I have no permanent damage.

    Posted on August 9, 2013 at 8:50 am

  • Karen says:

    I was put on Zetia (told not a Statin) and started with an ankle giving out, after my PCP and 2 orthopedics said nothing was wrong, needed orthotics, I started doing research. I told all the doctors about cramping and extreme knee pain, where I could hardly walk at age 55 and I had previously walked 3-5 miles a day. NOT one of them thought of the drug. I just (3 days ago) stopped, I pray the damage is not permanent. I had rotator cuff surgery 9 weeks ago.. I hate pain. Please tell me that my legs will return to normal. It hurts so bad behind my knees and all the way up to my hip. Poisoned by modern medicine.

    Posted on October 2, 2013 at 9:46 am

  • Diane says:

    I’m not sure exactly how long I’ve been on Zetia. Was getting free samples from doctor because of the high cost. Free samples stopped this past year, so was off of med for a couple months. I started back on Zetia, as prescribed, for approximately two months, when I started experiencing some symptoms. I figured some were due to being 73 years of age. Some to weather changes, some to Mr. Arthur and some to possibly the flu. Except more and more symptoms were happening. I knew this wasn’t because of my age. I am a young 73 and there was more here than met the eye. I started doing a research on Zetia, and was shocked to find out that these side effects were also experienced by others on the same medicine.

    I went off of Zetia immediately and within two days some of the side effects are gone. It’s been eleven days now and I still have back and leg pain. Shortness of breathe, legs cramps, charley horses and tiredness.

    cold or flu-like symptoms
    difficulty in moving
    dryness or soreness of throat
    muscle pain or stiffness
    hip pain
    pain in joints
    shortness of breath
    stuffy nose
    tightness of chest or wheezing
    trouble in swallowing
    unusual tiredness or weakness
    leg cramps and charley horses
    also my memory is not as good and I’m more irritable. –
    I was not able to walk very well either
    hurting in lungs
    hurting in joints
    legs hurting
    feel funny (sometimes have experienced a very heavy weakness, sweating, and legs not very
    funny feelings throughout my head
    wake up wheezing
    sometimes have trouble finding the right word to use
    acid reflux
    kidneys hurt
    lower back
    rib cage hurt
    front bone in both legs would hurt
    knee down to ankles burning at times

    Posted on April 20, 2015 at 8:49 pm

  • Donna says:

    Ruined my thyroid. Lost 60 lb in no time. Look awful. Muscles deteriorated. I feel like I am dying.

    Posted on May 17, 2018 at 8:07 pm

  • Barb says:

    I was put on Zedia for High colesterol. Eight days and i couldn’t stand the pain.. stopped the med.14 days later my pain and headaches are worse. I’ve never experienced something so bad from a well known drug. It’s POISON!!!
    Now i pray my body returns to normal. My memory has gotten worse, and leg cramps haven’t left.Going to my primary physcian for testing.

    Posted on July 13, 2019 at 12:42 pm

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