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papau Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 11:32 AM
Original message
Lawsuits Filed Over Lipitor Side Effects
duty to market it responsibly and adequately disclose side effects?


http://hosted.ap.org/dynamic/stories/L/LIPITOR_LAWSUITS?SITE=FLTAM&SECTION=HOME&TEMPLATE=customwire.htm

Lawsuits Filed Over Lipitor Side Effects

By DAVID B. CARUSO
Associated Press Writer

NEW YORK (AP) -- Two men who believe they suffered lasting muscle damage from taking the popular anti-cholesterol drug Lipitor are suing medication's maker, Pfizer Inc., claiming the company didn't issue loud enough warnings about potential side effects.

Charles M. Wilson, a former insurance executive from Atlanta, and Michael Mazzariello, an attorney from New York City, said in separate lawsuits (filed Wednesday in Manhattan's State Supreme Court) that they began experiencing debilitating pain, weakness and memory problems after taking the drug.

"It ruined my life," said Mazzariello, 47. He said that within weeks of going on the medication, he couldn't walk without a cane, tend his garden or lift his 1-year-old child.

The symptoms subsided once Mazzariello stopped taking the medication - he stood under his own power at a news conference Thursday at a Manhattan hotel - but he said he still suffers from pain, fatigue and a tingling sensation in his hands and feet.<snip>

One of those warnings, prominently posted on the company's Web site about the drug, cautions patients to "tell your doctor if you feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects."

Haskins said the number of Lipitor users experiencing those symptoms is "very, very small ... well under 1 percent," and that they are far outnumbered by the millions of people who have taken it safely.<snip>

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mdmc Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 11:33 AM
Response to Original message
1. I worked on Mazzariello's political campaign for Town Justice
He almost died from the side effects of this drug...
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papau Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 11:43 AM
Response to Reply #1
3. With my Gout/Arthritis it would be hard to blame muscle/joint pain
on Lipitor - but I might try as the timing actually is "right" - switched to lipitor and now it is difficult to type even.


In any case, I am glad Mazzariello is feeling better - at least as per article.

And good for you on working on a local race. I did that in Newton 2 years ago and my man said in the debate that he felt the town could select anyone of the three that were running as they were all solid candidates!

:-)
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MADem Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 11:38 AM
Response to Original message
2. Shit, IS there a SAFE cholesterol drug???
Mine has gone up lately, and if I can't get it down, I'm gonna have to join the pill set. I'm doing the low cholesterol diet thing, but damn, I'm not much of a meat eater as it is, and it's a real pain in the ass. Plus, I LIKE cheese, and that's a horrific sacrifice!
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papau Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 11:45 AM
Response to Reply #2
4. Zetia - safe but it works by stopping digestion - so fats flows as well as
gas.

But it is a great way to make you pay attention to having a low cholesterol diet - 'cause if you don't you get reminded!
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MikeDuffy Donating Member (309 posts) Send PM | Profile | Ignore Fri Jun-09-06 12:22 PM
Response to Reply #4
5. Haven't noticed a problem like that w/ Zetia
at least not yet! I have been taking it (10 mg) for about 4 months. Changed from 20 mg Zocor after it increased from 10 mg and started having dizzy spells. Before Zocor I was taking Lipitor, but asked doc to change because of reported adverse memory side-effects.

With any new medication that doesn't have a lengthy track record for it or drugs with similar ingredients you are taking a real risk, more so these days. Better by far to first try long-time existing drugs, where the side effects are known.

I may yet be sorry I started taking Zetia, my fingers are crossed...
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papau Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 12:33 PM
Response to Reply #5
7. Two days of excellent large steaks cook in butter, plus boston baked
beans home made very heavy on the bacon fat, plus Marie's salad dressing on a salad that was more a dipping dish, plus corn and butter, plus a couple of rashers of bacon with a half dozen eggs plus 2 pints of Ben and Jerry's each day - and from then on you do not challenge our friend Zetia. Plus you note the 3 pound weight gain and see another reason to stay on a heart health diet!

I was feeling way way down over some items and was using food for comfort.

I now use hot tea for comfort.
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MADem Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 12:29 PM
Response to Reply #4
6. That doesn't sound like much fun!!! NT
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Warpy Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jun-10-06 09:08 AM
Response to Reply #2
12. Try whole oats
meaning oatmeal or cold whole oat cereal in the mornings, every day. It doesn't cost much, it's a good breakfast option, and lots of folks have seen a significant improvement in their numbers.

I would never suggest anyone go off statin drugs that are working well for them without the rare but serious complication of rhabdomyolysis. However, adding the whole oats to the regimen has helped a lot of people tremendously.

However, if you're not at the pill stage yet or if you're unable to tolerate any of the statins, try the oats. The only thing you have to lose is lousy choleasterol numbers.
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MADem Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jun-10-06 02:30 PM
Response to Reply #12
14. Yeah, we do the Irish Oatmeal thing every now and again
It's just not my favorite breakfast, having been raised on the stuff as a youngster, every damn day, it seemed! But I suppose a bowl of "gruel" beats taking pills, if one can help it!
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Warpy Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jun-10-06 03:28 PM
Response to Reply #14
17. My mother refused to do the oatmeal thing
because she got it three times a day during the worst part of the Depression. Consequently, I just never learned to like it much.

My oats are Oatios from the health food store. I eat them for snacks rather than for breakfast.
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MADem Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jun-10-06 04:05 PM
Response to Reply #17
18. Now, THAT's a thought!!! n/t
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baby_bear Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jun-10-06 01:28 PM
Response to Reply #2
13. Red Yeast Rice - an OTC supplement
My chlolesterol improved markedly after just a few weeks on it. My doctor said he had never seen anything like it. I have read that it can cause liver problems similar to Rx cholesterol drugs in some people, but I have not read that it causes the muscle problems.

You should get the type that has CoEnzymeQ with it, as it depletes that.

You can Google on it or you can send me a private message to get the actual brand I use. I don't like to advertise for anyone in this venue.

b_b

P.S. Don't take it with grapefruit juice, as it enhances its effects. That could be good or bad, so best to avoid the combination.
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MADem Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jun-10-06 02:35 PM
Response to Reply #13
15. Is it expensive? How does it work?
Oddly enough, I can get prescription drugs for free, or for three bucks if I don't want to drive to the base. I just hate the idea of being chained to a pillbox and a pharmacy, is all!
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Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Jun-10-06 03:12 PM
Response to Reply #15
16. It works the same way as the statins
so if you don't like the statins, you might not like red yeast rice.

Many of these supplements are combined with COQ10, however, unlike the drugs.

I don't have a price. I always order online from papanature.com because it is cheap. Swanson's vitamins and others are also cheap.
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Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 12:46 PM
Response to Original message
8. seems like a long shot
Unless people were not warned of these possible side effects (but they were, right?). Now, I do wonder about whether people should be told to take Coenzyme Q10 with this, and told of possible depletion. I guess what I am saying is that if I were the lawyer, I would look into that angle of it. But drugs that are life saving to some people can ruin the lives of others. The warnings should be clear and specific, and people should not take them lightly.
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papau Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 01:25 PM
Response to Reply #8
9. Coenzyme Q10 with this, and told of possible depletion?? - I thought blind
studies showed no effect for Q10?

What is the depletion claim? Is it asserted that Lipitor causes such, and is the claim then that Q10 fixes?

The $35 price on a months Q10, plus the "no effect" reports, has stopped me from buying.
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Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 02:24 PM
Response to Reply #9
10. studies
I don't think there are very many in humans, actually. Whether a study shows a benefit or not of course depends on a lot of things-- subjects, dosage, time, etc. One negative study only proves no effect for the particular parameters used. I am not really familiar with the studies, but if I were a lawyer I would make it my business to get familiar with them.

I did find this study--

1: Curr Opin Clin Nutr Metab Care. 2005 Nov;8(6):641-6.

Clinical aspects of coenzyme Q10: an update.

Littarru GP, Tiano L.

Institute of Biochemistry, Polytechnic University of Marche, Via Ranieri, Ancona, Italy. g.littarru@univpm.it

PURPOSE OF REVIEW: Coenzyme Q10 is administered for an ever-widening range of disorders, therefore it is timely to illustrate the latest findings with special emphasis on areas in which this therapeutic approach is completely new. These findings also give further insight into the biochemical mechanisms underlying clinical involvement of coenzyme Q10. RECENT FINDINGS: Cardiovascular properties of coenzyme Q10 have been further addressed, namely regarding myocardial protection during cardiac surgery, end-stage heart failure, pediatric cardiomyopathy and in cardiopulmonary resuscitation. The vascular aspects of coenzyme Q10 addressing the important field of endothelial function are briefly examined. The controversial issue of the statin/coenzyme Q10 relationship has been investigated in preliminary studies in which the two substances were administered simultaneously. Work on different neurological diseases, involving mitochondrial dysfunction and oxidative stress, highlights some of the neuroprotective mechanisms of coenzyme Q10. A 4-year follow-up on 10 Friedreich's Ataxia patients treated with coenzyme Q10 and vitamin E showed a substantial improvement in cardiac and skeletal muscle bioenergetics and heart function. Mitochondrial dysfunction likely plays a role in the pathophysiology of migraine as well as age-related macular degeneration and a therapy including coenzyme Q10 produced significant improvement. Finally, the effect of coenzyme Q10 was evaluated in the treatment of asthenozoospermia. SUMMARY: The latest findings highlight the beneficial role of coenzyme Q10 as coadjuvant in the treatment of syndromes, characterized by impaired mitochondrial bioenergetics and increased oxidative stress, which have a high social impact. Besides their clinical significance, these data give further insight into the biochemical mechanisms of coenzyme Q10 activity.

Publication Types:
Review

PMID: 16205466

Here is Harvard's take on it==

1: Harv Health Lett. 2005 Jun;30(8):4. Related Articles, Links


Statins and their side effects. Some evidence suggests coenzyme Q10 might help with muscle problems, but it's too early to recommend it.


PMID: 16136675

However, earlier I think I posted two different medical centers that recommend coenzyme Q10.
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papau Donating Member (1000+ posts) Send PM | Profile | Ignore Fri Jun-09-06 03:36 PM
Response to Reply #10
11. thanks - I appreciate the info - I am off to get a bottle to add to the
line up I have now!

:-)
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baby_bear Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Jun-11-06 01:41 PM
Response to Reply #11
19. Here's one more suggestion about the red yeast rice
I take the NOW Foods brand, e.g., available at http://www.harvesthealth.com/redyeri600mg.html
and elsewhere..
It is 600 mg red yeast rice with 30 mg CoQ10 and it also contains milk thistle which is a great
supplement for liver protection; very good idea when taking a statin-type drug, whether a supplement
or an Rx. I take milk thistle separately as well (because I like wine).

Anyway, the recommended dosage is 2 tablets a day, but I take only one, and had incredible results
within just a few weeks. .
So I would suggest you try the lower amount for a few weeks - maybe six - and then get your
cholesterol and trigycerides checked again. Not a bad idea to get liver enzymes checked as well.
Then you can decide if you need or want to increase the dosage. It's always best to take the least
amount possible, for your body and your wallet!

Good health to you.

b_b

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Celebration Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Jun-11-06 02:16 PM
Response to Reply #19
20. I would just add
Thanks for the info. Some people here are on statins, and I would just remind everyone that red yeast rice *is* a statin, so probably not a good idea to be on BOTH statin and red yeast rice. And because it works as a statin, it is subject to the same possible side effect profile, plus likely need for COQ10, and the whole ball of wax. For awhile the FDA managed to keep red yeast rice banned, it being a competitor of statin drugs, but it is back on the market again and has been for some time. Sure seems like a decent thing to try for people who do't have insurance paying, need statin drugs, and don't mind doing a little experimenting on themselves (including getting the appropriate blood work done!!). If the rolled oats works then all the better.
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baby_bear Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Jun-11-06 10:48 PM
Response to Reply #20
21. itsfustme is correct
Red Yesst Rice should be considered as essentially a statin drug. Therefore the "be carefuls" about liver toxicity apply.

However, it is not a synthetic drug and some may feel it has better benefits than a synthetic.

I do think tht the COQ10 and sylmarin supplements are essential, but I wouul also argue that for regular statin prescription drugs.

b_b




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jbnow Donating Member (1000+ posts) Send PM | Profile | Ignore Sun Jun-18-06 01:07 AM
Response to Reply #11
22. You aren't likely to see this
It's been too long.

There is NO doubt about the coq10 depletion. What blocks the cholesterol from forming also blacks the coq10. It has a common biosynthetic pathway with cholesterol.

It's too late to look now but studies are clear about it, even in younger people used in the studies. No one should take a statin drug without the supplement.

I force those close to me using statins to use c0-q-10. Someday this will be a bigger lawsuit than Vioxx. Good Lord, merck even put a patent on a form of statin that included the enzyme 20 years ago, They know.
Most doctors don't know because the FDA didn't tell them.

It's not just the pains and weakness that the depletion causes, CHF (chronic heart failure) is on the increase due to statins as well. I researched this thoroughly in the past when a friend went on a statin and started having problems, but it's late...

Just let me add that many brands of coq-10 don't contain what they say they do. I subscribed to consumerlab.com, an independent testing lab for vitamins and supplements. There were more that passed but I am stingy. The one I encourage people to buy that passed the testing is Nature Made. At least every month Walgreen's has Nature Made products for Buy 1 Get 1 Free. Much less expensive that way for a good product.
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