Posted on 12/22/2007 2:30:45 AM PST by neverdem
New evidence shows that the drug makers Merck and Schering-Plough have conducted several studies of their popular cholesterol medicine Zetia that raise questions about its risks to the liver, but the companies have never published those results.
Partial results of the studies, alluded to in documents on the Food and Drug Administration’s Web site, raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins.
Most of the millions of people who use Zetia take it along with a statin like Lipitor, Crestor or Zocor. Or they take it in a single pill, Vytorin, that combines Zetia with Zocor.
The discovery of the unpublished research comes as Merck and Schering are already under criticism for not yet releasing data from an important Zetia study, called Enhance, that they completed early last year.
The Enhance data may also contain important information about Zetia’s liver risks. At least some patients were dropped from the Enhance study after testing revealed that they had elevated liver enzymes, a Schering-Plough spokesman confirmed this week.
But a full report on that trial, including the number of patients who had liver problems, will not be available until March.
Doctors say that by failing to disclose promptly all their research, Merck and Schering-Plough may be leaving the public with a misleadingly favorable view of Zetia’s safety and benefits.
“You don’t want to have data missing,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. “When there have been adverse effects, when the benefits don’t...”
--snip--
But in Australia and Canada, regulators have been more cautious. Since 2005, they have issued a series of warnings about Zetia’s potential to cause hepatitis, pancreatitis and depression — warnings that have largely gone unnoticed in the United States...
(Excerpt) Read more at nytimes.com ...
Scientists Weigh Stem Cells’ Role as Cancer Cause
FReepmail me if you want on or off my health and science ping list.
“Zetia’s potential to cause hepatitis, pancreatitis and depression”
Statin drugs are not worth the risk, especially when you consider that they don’t even bring down cholesterol that much.
The link between heart disease and cholesterol is based on a flawed study back in the 50’s or 60’s. The long-term Framingham study has found just the opposite to be true.
Thanks for the ping. My husband takes Vytorin, time for a doctor’s appointment and questions I think.
This does not look like good Science. Statins are known to disrupt certain liver functions, and people taking them are thus routinely tested. Evaluating Zetia in patients taking it in combination with a statin is multiplying variables. Zetia may potentiate the effects, though, both good and bad.
Data is needed for Zetia alone, first.
Do you mean that high cholesterol is a good thing?
Did I say that? Of course not.
Cholesterol is important in brain function, which explains why one of the possible side effects of statin usage is dementia. When you throw in possible symptoms of neuropathy, liver disease, fatigue, and a host of other potential problems, you have to ask whether the statin "cure" is worse than the disease.
"Dr. Uffe Ravnskov, MD, PhD, who wrote the book The Cholesterol Myths, goes through study after study destroying the idea that high cholesterol levels are the cause of heart disease. In the Framingham heart study done near Boston that spanned 30 years , the researchers concluded that high cholesterol was a risk factor for heart disease, but when one really dissects the data, one must question how they came to that conclusion. For example, when the participants of the study are plotted on a graph it clearly shows that those with cholesterol levels between 182 and 222 did not survive as long as those with higher cholesterol levels of between 222 and 261. The study shows that about half the people with heart disease had low cholesterol, and half the people without heart disease had high cholesterol."
The issue with heart disease is not cholesterol but inflammation. That's why statins seem to improve deaths from heart disease -- not because lower cholesterol prevents heart disease but the statin's ability to reduce inflammation in the blood vessels.
Statin drugs are a lousy way to lower inflammation (which can be measured by blood tests). Changes in lifestyle -- nutrition and appropriate supplementation -- to lower inflammation markers don't have the nasty side effects that statins do.
There is a wealth of info out there on cholesterol and heart disease. If you get away from the pharmaceutical industry-funded websites or other sites with built-in bias of selling a product you can find good data.
Thanks for the post. I started on Zetia about 2 months ago because I didn’t want to take Lipitor. I know two people on that with messed up livers because of it. I’m going to call my doctor first thing Monday and stop taking this crap.
My heart doc is one of the brightest people on the planet. I trust him without reserve. He explained the risks/rewards of statins and I take the pills. They haven't killed me yet and I'm no longer symptomatic.
>>>Thanks for the post. I started on Zetia about 2 months ago because I didn’t want to take Lipitor. I know two people on that with messed up livers because of it. I’m going to call my doctor first thing Monday and stop taking this crap.
I nearly died in April ‘06 from necrotic pancreatitis that they say was gall stone induced....but I’ve been on Zetia too, and now wonder if it played a role....Hmmmm...
www.curezone.com is a great website. Read it before starting drugs.
“My heart doc is one of the brightest people on the planet.”
Really? I wonder if he knows that heart disease is not caused by cholesterol and that statin drugs only help heart disease patients by reducing inflammation.
Statins are a still risky way to reduce inflammation compared to the alternatives.
I'll be sure and tell him you disagree. I'm sure he'll defer instantly.
All these cholesterol drugs have consequences.
I was taking Zetia and Lipitor until my feet hurt so bad I could hardly walk. I cut out the Zetia myself.
These drugs do 2 things, lower cholesterol and make it so that healing from anything takes a long long time. I learned, about 5 years ago, that if I get a cold or flu, or I get cut or bruised, I need to stop these meds or it will take forever to get better. If I get a cut on my hand while working around the house, for instance, 3 to 4 months to heal while taking statins or stop the statins and heal in 1 to 2 weeks.
I wonder what else they are doing to me.
“I’ll be sure and tell him you disagree. I’m sure he’ll defer instantly.”
We all put our trust in whatever or whomever we choose.
“I was taking Zetia and Lipitor until my feet hurt so bad I could hardly walk. I cut out the Zetia myself.”
I have a relative that had the same issue. But the doctor gave her something else for her foot pain, and then something else for the side effects from that. . . . .
These things can be a never-ending cycle. But I didn’t realize that they impaired immune system and tissue repair. That’s a very serious side effect.
What I want to know is this, will it make them stop broadcasting those horrid commercials?
“What I want to know is this, will it make them stop broadcasting those horrid commercials?”
Only if the payouts to the injured parties get high enough.
“The study shows that about half the people with heart disease had low cholesterol, and half the people without heart disease had high cholesterol.” “
that is the truth - there is absolutely no correlation between serum cholesterol and heart disease.
you are right re: inflamation and thats why aspirin is so good as is good dental care and avoidance of all low level infections like ulcers and i think even acne.
I couldn't handle the muscle pain and weakness taking it daily...
Doctor is now trying it on me with dosage of twice a week....
Will see how that goes soon.
Now that is interesting..didn’t know that....takes me a while to come back after a cold....
How about Red Yeast Rice?
I'll let mine know too. I've taken Zetia for many years with no problems. I also take an evil statin.
Would you happen to know if Norvast causes the same issues ?
My father is a very healthy 78 yo but he now has difficulties getting up from the floor or walking down steps ever since he started taking Norvast a year or so ago.
“How about Red Yeast Rice?”
You mean to reduce cholesterol? What’s the point if the cholesterol level is not extraordinarily high, and the other factors look fine?
I think you mean Norvasc, right?
Here’s what side effects at liste at drug.com:
“If you experience any of the following serious side effects, stop taking amlodipine [norvasc] and contact your doctor immediately or seek emergency medical treatment:
*
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
*
unusually fast or slow heartbeat;
*
chest pain;
*
severe dizziness or fainting;
*
psychosis;
*
jaundice (yellowing of the skin or eyes); or
*
swelling of the legs or ankles.
Other, less serious side effects may be more likely to occur. Continue to take amlodipine and talk to your doctor if you experience
*
fatigue or tiredness;
*
headache;
*
insomnia;
*
vivid or abnormal dreams;
*
flushing;
*
abdominal pain;
*
nausea, diarrhea, or constipation; or
*
increased or difficult urination.
“
I did not know about the muscle pain and weakness - husband has been complaining about that, we thought it was the cold weather. Let me know what happens.
Hubby took vytorin. Turned his feet black when he bathed. He is now on crestor. He also takes red yeast rice, coQ10 (which everyone should take if on statins) and eats oatmeal. Added the oatmeal and red yeast rice this year and is going to taper off the statin. The RYR and oatmeal will do what the statins do.
Thanks for the information. Hubby takes CQ10 but eats oatmeal only occassionally. Had not heard about red yeast rice but will try it.
The oatmeal will raise the good cholesteral and lower the bad. I make his with brown sugar and cinnamon or just real maple syrup. The RYR is the same as a statin but, IMO, better. The COQ10 is good for anyone over 50 to take. The body makes it I think and it starts to not do it after 50.
Hubby is a diabetic, however, the cinnamon is good for him. I’ll have to start keeping plenty of oatmeal around for him for breakfast.
Questions and informed patients are good, but specific complaints focus the mind.
"Partial results of the studies, alluded to in documents on the Food and Drug Administration’s Web site, raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins."
It's not that you couldn't have an adverse drug reaction caused by Zetia itself, but this story involves Zetia and statins.
http://www.fda.gov/default.htm
I wasn't able to find it.
Elevated enzyme levels took me off the two. Fish oil is my friend.
I take daily elevated dosages of B6, B12 and folic acid to reduce the amount of homocysteine. Does this also reduce inflammation?
The anti-inflammatory effect of statins has been noted, in particular, the reduction of C-reactive protein, IIRC. The inflammatory response is part of an intact immune system. Somehow, you seem to be quite sensitive to statins.
Statins have anti-inflammatory effects which you noted, IIRC. See comment# 37.
That's the sine qua non of statin induced myopathy. Myoglobinuria cinches the diagnosis, IIRC. Rhabdomyolysis can cause renal impairment. IIRC, you're in that unlucky 1%.
Norvasc is the only drug with close to that spelling that I know. Fatigue is a recognized side effect.
Speak for yourself. I take the dreaded combination pill, Vytorin, at lower doses than a single drug pill I had been taking. Mine went down quite a bit.
Two OO capsules per day of a good hot cayenne will lower cholesterol.
If that doesn't lower it enough for you then take a deodorized garlic capsule. (Or if you don't mind the odor eat two raw cloves of garlic.) If that still doesn't do it then eat 3 shitake mushrooms (the smallest you can find, fresh or dried, eaten in any way you like) for 30 days and your cholesterol will definitely be significantly lower.
bump
Weight lifting is supposed to increase the “good” cholesterol.
Thanks, I believe that also. His diet is a fairly low carb diet, sorta of a modified South Beach. Other than when it’s extremely cold, he does get a fair amount of exercise, feeding and exercising the horses and taking his hunting dogs out to run. Just that last year though, he has had to increase all of his meds and start taking some new ones, including the Vytorin.
I went to a cholesterol class because mine was a little high. During the class another student mentioned that one of the side effects listed on his medication was “Death.”
With those kind of warnings I’ll take my chances with the cholesterol!
Anyone taking a statin can develop jaundice, WHICH IS NOT HEPATITIS!!
Just another attempt by social leftists and the trial lawyers to bring down Merck, the greatest pharmaceutical company EVER! You morons owe your very lives to this company and yet your so naive and gullible you'll buy anything from these a-holes!
LOL - My doctor had me on three different statins over about 6 months because I kept complaining about the side effects. I finally told him no - I won’t take anything for cholesterol, period. Even the Niostan caused me to become hyper allergic.
As for the lifting, supposedly doing some weight lifting exercises keeps you younger. It’s asking for a different type of exercise than your brain is accustomed to and therefore causes changes in your brain. I try to do some lifting with my tiny little weights :) if for no other reason than to keep my arms toned. I tried to get hubby to do it but he refuses.
Thanks..thats good info to know
“Speak for yourself. I take the dreaded combination pill, Vytorin, at lower doses than a single drug pill I had been taking. Mine went down quite a bit.”
You missed the point.
Bringing down cholesterol doesn’t improve heart disease. Read the earlier posts; there’s lots of data on this subject. Controlling inflammation is what’s important, not lowering cholesterol.
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