# Trust, but Verify



## Tom Young (Mar 13, 2014)

*Experimenting with drugs*
Upfront... sounds like an introduction to today's funniest comments, but......

Totally serious, and for DW and me, actions that have helped us, and we think, may be extending our livespan. 

Sometime ago, I had written here that we listened to our doctor, and didn't second guess her recommendations for pharmaceuticals, except to request generics. That's true... but there's a second part of this, and that is we watch our health, and do some experimenting with dosages. In most cases, it's a matter of balancing health and side effects. 

To begin, since it's usually a one time thing, we read as much as we can on the WebMD and similar website about the interactions, side effects, dosage amounts, warnings etc. More practical than the fine print fact sheets that accompany the prescriptions. 

After that, we take the medicine as recommended, and consciously watch for side affects... sleep, intestinal problems, nervousness, whatever was part of the "possibles". 
.................................................
Next, instead of tryingto explain, some experiments, and what we did to improve.

Frist, was Lipitor... started when it was introduced, and it did drop the cholesterol readings, successfully... Kudo's to the Doctor. Some four years later, with tweaks in the arm, thought to be from tennis injury, then some aching in the legs, Doctor diagnosed arthritis, and prescribed Celebrex. It helped. (this was before Lipitor and muscle weakness reached the news)... 
The price of Celebrex seemed high, so turned to aspirin, but with more tummy problems... Finally decided to stop lipitor... an experiment. In two weeks, leg and arm pain went away. Doctor recommended Simvastatins, and that worked pretty well... but Triglycerides were still very high... 700+... Went to Crestor, that helped, but still expensive. We changed doctors because of moving. New doctor prescribed fenofibrate (generic) and that worked for aches, cholesterol and triglycerides, plus reasonble cost. 

Next, borderline diabetes... Dr. prescribed Metformin, diagnosing metabolic syndrome. Took the pills for a year, then after a summer of moderate exercise, lost about 7 pounds. Went off the metformin at camp, when I ran out of pills for a week. At a mall health clinic, had a free blood test with result of 74... below the 114. So much for metformin... wouldn't have known, except for that test. Blood sugar, now fine. 

Then... DW... several different situations, now all under control, but a few interesting experiments. 

An accidental experiment for me... At the time, she had been taking clonazepam for another reason... I had begun to have sleep problems... down to 2 or three hours/night. Doctor prescribed the OTC Benadryl first, which just made me dopey, but with very restless sleep. Changed to Ambien... For me awful... sleep, but with continuous nightmares and terrors. Then (I wouldn't usually do this, but tried DW's clonazepam, and slept like a baby. Worried about addiction, tlked to Dr. and she rhetoriacally asked me... "how old are you"... and when I told her, she laughed and said "... and you're worried about addiction?" So now, have the prescription... .25 mg to.50mg/night and life is good. 

DW takes BP Amlodipine, and gets "good show" at Dr. office for BP in the 110/65 range... Trouble is, she has had some dizzy spells, when getting up from a chair or rapid movement... We have a home BP machine so started monitoring regularly... sometimes, as low as 95/50. This time, we did it on our own... cut pill in half, and watchfully see BP up into the 120 to 130/75 range... low for our age, but a little higher that what the office praised her for. The good part... dizzy spells are gone, and more energy. 

One more... Two years ago, after having hand "pins and needles" and some pain especially at night, a doctor... neuropathy... diagnosed as carpal tunnel. An operation... $12K... but no relief... sent to a neuropathy specialist who wanted to do a huge battery of tests, but when pressed for expectations was non commital. I did some very extensive reading about the problem, and came to the conclusion that it was peripheral neuropathy... with an almost zero chance of improvement... OLD AGE... Coming to grips with that, life has normalized... and in the way people with permanent disabilities deal with them, have made it a tiny part of my life. Don't even notice it any more. Have a prescription for nerve pain, ... gabapentim, but harldly ever use it.

Over the years, we've had many more self diagnosis/medication situations, but not necessary to list here. Here's the point of the post... As we look around us at people who are as old and older than us, we see many who are taking as many as 15 different pills/day. Not for us to say whether they are needed or not. Most of them trust their doctors, and credit medication with keeping them alive. At the same time, I do not and could not criticize the doctors, as their prescriptions are based on blood tests, and the symptoms that present. Also, I would guess, more likely to add a prescription and watch the results, than to take away and see more problems or death. 

For us, it takes some effort to read about and understand our personal health, but we feel it's worth the extra effort. didn't intend this to be so long, but sometimes personal experiences mean more than long narratives. I believe that sharing, helps in understanding. 
As always, my opinion only... YMMV


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## Warrigal (Mar 13, 2014)

I'm interested in Lipitor and muscle weakness and arthritis.
I'm on Lorstat, a generic of Lipitor I believe, and I'm having a lot of trouble with my legs and now my shoulders.
I'm due to see the heart specialist soon so I'll mention it and see what he says.

Thanks, Tom, for this post.


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## Vivjen (Mar 13, 2014)

Hooray.....somebody who intelligently enquires and tests their medication!

You control your medication; it does not control you; and an intelligent dialogue with your doctor/pharmacist can avoid many problems.


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## SifuPhil (Mar 13, 2014)

Vivjen said:


> ... and an intelligent dialogue with your doctor/pharmacist can avoid many problems.



This is something that I do not understand, Viv - perhaps you could enlighten me ...

My private student is a long-time pharmacist - used to own his own franchise but burned out after 25 years or so. He now works "part-time" (30-35 hrs / wk) at another pharmacy - from the same franchise - as "just a pharmacist".

He regularly tells me of people coming into the shop and asking him questions that, in my opinion anyway, would be far more appropriate - and legal - to ask their doctor.

Now, I understand that the issue is often one of time and convenience - it's tough to schedule a doctor's visit and they aren't a captive audience like my student - so they'll come in and relate their medical history and ask for treatment advice.

My student, while trying to be helpful, is ever-mindful of the law and thus has to walk a fine line.

Basically, I see a broken system when a patient is asking their pharmacist for medical advice and only go to their physician for prescriptions.


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## Mrs. Robinson (Mar 13, 2014)

I,too,had nothing but problems with any of the statins. Leg pain and shoulder pain on Lipitor,Crestor,Simvistatin and another that I have forgotten the name of. Doctor took me off and within a week my pain was gone. Since that time,I`ve heard some negative things about statins,whereas ten years ago my doc told me that cardiologists had once told her that they were the greatest med ever invented and that pretty much everyone should be taking them. But for me,the pain was just too much to deal with.


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## d0ug (Mar 13, 2014)

The fact is in 2012 the FDA contacted doctors and told them to get their patience off statins as they cause 52% chance of diabetes and 100% chance of dementia [Alzheimer]  I guess your doctor was too busy to tell you.


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## Jillaroo (Mar 13, 2014)

_I have made the decision to wean myself off the tablets my neurologist has put me on due to the fact that the MRI & Doppler were normal, i refuse to keep taking tablets that basically stop seizures but also work on nerves  when all they do is make me feel like a zombie and want to sleep all day, i have put up with the pain for 21/2 years so i can put up with it for however long it is giving me grief and just take pain killers when it's really bad.
                           The doctors put me on Simvastatin years ago and i was always itchy so went off them and they have been trying to get me on them ever since, i refuse to take them, there are natural ways of reducing the cholesterol like Aloe vera or Beetroot juice_


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## d0ug (Mar 14, 2014)

Unless your cholesterol is over 270 than you have no problem the  naturopath doctors say good cholesterol range is from 220 - 270


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## Vivjen (Mar 14, 2014)

Phil; yes there is a fine line...
Over here; pharmacists dispense medicines prescribed by a doctor.
under that heading comes giving advice over side-effects; when best to take them; any interactions with other medicines they are taking; when and whether to stop taking them; what they are used for (yes!) and any other questions about compliance etc.
also, when to return to the doctors if necessary, and how to tell if they are doing what the patient wants them to, and what the doctor expects.

We also trat a lot of self-limiting conditions...fungal infections of skin and nails; mild to moderate pain; and all types of illnesses which you have ever heard of, and some you haven't!

We are supposed to use our professional judgement about what we can treat, and what people have to attend their doctors for.

Doctors are ok at diagnosing, and choosing the medicine that in theory works.

Pharmacists tend to do all the practical stuff; including checking the script is legal, and many interactions.

Because the NHS is free at the point of delivery; many pain-killers, and creams etc available OTC are not allowed on prescription; I expect that doesn't happen in the US.

Also, we don't have an appointment system; in some places people have to wait 2weeks to see their GP; which would you prefer; a pharmacist or a doctror's receptionist?!


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## Vivjen (Mar 14, 2014)

Statins are another subject entirely!


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## SifuPhil (Mar 14, 2014)

Vivjen said:


> Phil; yes there is a fine line...
> Over here; pharmacists dispense medicines prescribed by a doctor.
> under that heading comes giving advice over side-effects; when best to take them; any interactions with other medicines they are taking; when and whether to stop taking them; what they are used for (yes!) and any other questions about compliance etc.
> also, when to return to the doctors if necessary, and how to tell if they are doing what the patient wants them to, and what the doctor expects.



"When and whether to stop taking them" - see, in my mind that's the physician's responsibility, because it's getting into actual treatment protocol. Again, I'm just an outsider and going by what my student says.



> We also trat a lot of self-limiting conditions...fungal infections of skin and nails; mild to moderate pain; and all types of illnesses which you have ever heard of, and some you haven't!
> 
> We are supposed to use our professional judgement about what we can treat, and what people have to attend their doctors for.
> 
> ...



I get the impression that pharmacists work a LOT harder than most doctors.



> Because the NHS is free at the point of delivery; many pain-killers, and creams etc available OTC are not allowed on prescription; I expect that doesn't happen in the US.



I'm not quite sure how that would work here, either - I'll have to find out. 



> Also, we don't have an appointment system; in some places people have to wait 2weeks to see their GP; which would you prefer; a pharmacist or a doctror's receptionist?!



Certainly the shorter time period, UNLESS the problem I had was more properly treated by a GP. See, that's the thing I'm concerned about - pharmacists being used as doctors. I could foresee a lot of lawsuits coming up if you aren't careful ... 

This is all just academic for me, by the way, since I don't take pills or visit either doctors or pharmacists.


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## Tom Young (Mar 14, 2014)

> "This is all just academic for me, by the way, since I don't take pills or visit either doctors or pharmacists."



Bless you... academia forever! 
...........................................................................................

Back to Cholesterol etc... and the doctor visit... 
Based on age, higher readings for cholesterol, tryglycerides, PSA and blood pressure are more commonly accepted as "normal". 
In my case original LDL was over 350, and tryglycerides 1000 at one point. Even now, with medication, levels are in the high range, but the doctor seems to consider that ok, considering past history.
Have learned to understand blood tests, and *always *ask for a copy of the reults after annual physical. 


One more small point. Before we go to for a physical, we always spend some time, questioning each other (bride and self) about those little things that have bothered us during the past year... even if they don't seem too important. I make a list of the questions we need to ask... things that we used to ignore or forget about some years ago. Always have blood tests before the Dr. visit. 


We are very, very happy with our young 36 y.o. female doctor. She's up on the latest medicine, and if there's ANY question, instead of showing off her knowledge, she'll take a break and look up anything that she's not positive about. She has attained sainthood (for us) by spending an hour or more checking through every health item possible, and never letting us go with any kind of a question unanswered. We have never had a better doctor, or felt such confidence. (she's very personable, and calls me "Dr. Bob".)


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## Rainee (Mar 15, 2014)

Hi Vivjen.. Have you heard in UK that  hydrochlorothiazide.used in blood pressure medications causing nerve damage and pains in legs.. 
I for one seem to think it does... and I feel its what has been making my legs worse and weakening?.. I take avapro with hydrochlorothiazide . 
also my husband was on Liptor for over 20 yrs he developed hip and leg pains and shoulder pains.. he went to a new doctor who was from 
Yorkshire.. he said to my husband why are you taking 80mg of this medication.. in UK it is only allowed to be 40mg whereas he changed it down.. 
my husbands has had no change in his cholesterol  and blood pressure normal but the pains are gone.. so he never needed the other 40 mg in the first place..
do you also know about the drug alpha lipoic acid ? I think it can be bought over the counter and it helps peripheral nerve pains. do you know if its true?
thanks so much if you can answer this ... it means a lot to me..


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## Vivjen (Mar 15, 2014)

Hi Rainee,
hydrochlorthiazide is not  used  a lot in UK any more; especially in a combination; because of problems and side effects it causes.

There is now a 4 step algorithm for hypertension..and hydrochlorthiazide is introduced in step 2 with an ace-inhibitor, but you can use something else instead.
it may be worth seeing if irbesartan on its own does the trick; because you can upset your electrolyte levels.


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## Vivjen (Mar 15, 2014)

I would agree with Lipitor....20mg is the most widespread dose over here; 80mg hardly ever used!

Will deal with your last question later; a little conversion is required from my end...but I won't forget!


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## Warrigal (Mar 16, 2014)

I have decided it will be safe enough to conduct a little experiment.

I've decided to discontinue taking my Lorstat (Lipitor by another name?) for two weeks.
I will continue with the Panadol Osteo for one week then discontinue that too for the second week.

So far I've missed two cholesterol tablets and already my legs/knee are feeling brand new, I can rise from a chair with relative ease and I'm walking rather than shuffling. I'm amazed at the difference and I will certainly be talking to my doctors about this medication.


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## SifuPhil (Mar 16, 2014)

Warrigal said:


> ... I'm amazed at the difference and I will certainly be talking to my doctors about this medication.



Congratulations.

I think talking to your doctors about this will be preaching to a deaf choir - you can't talk a pill-pusher into giving up their business when it earns them so much money.


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## Vivjen (Mar 16, 2014)

I disagree Phil; but mainly because the healthcare systems are so different.

I would go with Warrigal all the way....and I know my doctor would agree..


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## SifuPhil (Mar 16, 2014)

Vivjen said:


> I disagree Phil; but mainly because the healthcare systems are so different.
> 
> I would go with Warrigal all the way....and I know my doctor would agree..



Perhaps my cynicism is running a bit hot today - please forgive me.


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## Vivjen (Mar 16, 2014)

Nothing to forgive; I just don't understand the healthcare system in US; our doctors make no money from their scripts ; so financial inducements are completely different?


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## i_am_Lois (Mar 16, 2014)

I know several people who take statins to treat cholesterol. It works well for them without side effects. I'm not so lucky.
Whenever I've taken statins, I have difficulty walking. Also (while on lipitor) my kidneys began to shut down. 
The doctor took me off statins immediately. He said there was so much dead muscle tissue in my system it overloaded my kidneys.
I can't take ANY statins. They all have similar ingredients and tear up my muscles.
The doctor told me we must remember that the heart is a muscle and the statins could damage it.
I've had one heart attack (before I ever went on statins) and certainly don't want to do further damage.

My point - If you have muscle weakness while taking statins STOP TAKING THEM!!!! 
Your heart is a muscle!


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## That Guy (Mar 16, 2014)

Vivjen said:


> I just don't understand the healthcare system in US;



Neither do we . . .


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## nan (Mar 16, 2014)

About seven years ago I stopped taking Pravastatin/pravacol as it was starting to affect my wellbeing with pains in the kidney area and also muscle pain, I weaned myself off them gradually and have felt much better for doing so, I also stopped taking blood pressure meds for high blood pressure  at the same time,now my blood pressure is below what it should be and I don't understand why I was put on them in he first place, I think too many Drs only take your pressure once and it shows up high so they then put you on meds when maybe they are not needed.
Here is a good link to see what Statins can do to you      http://spacedoc.com/statin_side_effects


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## SifuPhil (Mar 16, 2014)

Vivjen said:


> Nothing to forgive; I just don't understand the healthcare system in US; our doctors make no money from their scripts ; so financial inducements are completely different?



The U.S. medical profession has a long history of being the whipping boy of the pharmaceutical industry. In the '50's and '60's physicians would receive extravagant gifts, including sums of cash, to carry a specific pharmaceutical. They were basically being rewarded for being bird-dogs.

After a ruckus was raised over this practice, it went underground. Now, you cannot be a practicing physician for very long if you don't carry what your "masters" (the insurance companies) tell you to carry. So no, physicians are no longer rewarded for prescribing their drugs - now they are threatened if they do not. 

From positive reinforcement to negative, all in the course of a few decades.


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## Warrigal (Mar 16, 2014)

SifuPhil said:


> Congratulations.
> 
> I think talking to your doctors about this will be preaching to a deaf choir - you can't talk a pill-pusher into giving up their business when it earns them so much money.


Until my light bulb moment caused  by this thread I was ready to talk to my heart specialist about whether my heart is OK for an operation on my knees but now I'm going to question him as to the desirability of continuing medication originally prescribed 3-4 years ago that now seems to be adversely impacting my quality of life. 

I don't think it will be a pointless conversation and I am confident that my own GP will be receptive to my reporting that I do seem to be experiencing undesirable side effects. He has examined my knee X-rays and my knees are not that bad that an operation is warranted at this stage but I have been becoming less and less mobile over time. However, after skipping three doses of my cholesterol medication, I've been rejuvenated.

I am quite astonished by the difference.


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## Warrigal (Mar 17, 2014)

I've just returned from my GP. I showed him how dramatically better I am since skipping four Lipitor tablets. He showed me my recent blood test results that indicated no elevation in muscle enzymes (he has been watching for them) and explained that there are some patients who are affected but don't show elevated enzymes. 

I'm to continue not taking the tablets for another three days, then take them again for a week as a double check on the result of my experiment. I'll see him again in a fortnight.

I'm convinced right now because I  am rising from a chair with ease where before it was a struggle, and I actually feel some spring in my step again where before I was either waddling or shuffling.

Thank you once again, Tom, for some very useful information.


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## SifuPhil (Mar 17, 2014)

Okay, so he's not letting you go cold-turkey yet - that means you're still addicted.

JUST KIDDING!!!!! 

Here's Lipitor's warnings ...

________________________________________

*WARNINGS*

 Included as part of  the *PRECAUTIONS* section.


*PRECAUTIONS*

*Skeletal Muscle*

*Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LIPITOR and with other drugs in this class.* A history of renal impairment may be a risk factor for the development of rhabdomyolysis. Such patients merit closer monitoring for  skeletal muscle effects.

 Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine  phosphokinase (CPK) values  > 10 times ULN. The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increases the risk of myopathy/rhabdomyolysis.

 There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy  showing necrotizing myopathy without significant inflammation; improvement with  immunosuppressive agents.

 Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing LIPITOR. LIPITOR therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

 The risk of myopathy during treatment with drugs in this class is increased with concurrent administration of cyclosporine, fibric acid derivatives,  erythromycin, clarithromycin, the hepatitis C protease inhibitor telaprevir, combinations of HIV protease inhibitors, including saquinavir plus ritonavir, lopinavir plus ritonavir, tipranavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, and fosamprenavir plus ritonavir, niacin, or azole antifungals. Physicians considering combined therapy with LIPITOR and fibric acid derivatives, erythromycin, clarithromycin, a combination of saquinavir plus ritonavir, lopinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, azole antifungals, or lipid-modifying doses of niacin should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs or symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of either drug. Lower starting and maintenance doses of atorvastatin should be considered when taken concomitantly with the aforementioned drugs (see *DRUG INTERACTIONS*). Periodic creatine phosphokinase (CPK) determinations may be considered in such situations, but there is no assurance that such monitoring will prevent the occurrence of severe myopathy.

 Prescribing recommendations for interacting agents are summarized in Table 1 [see also *DOSAGE AND ADMINISTRATION*, *DRUG INTERACTIONS*, *CLINICAL PHARMACOLOGY*].


*Table 1: Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis*​ 
Interacting AgentsPrescribing RecommendationsCyclosporine, HIV protease inhibitors (tipranavir plus ritonavir), hepatitis C protease inhibitor (telaprevir)Avoid atorvastatinHIV protease inhibitor (lopinavir plus ritonavir)Use with caution and lowest dose necessaryClarithromycin, itraconazole, HIV protease inhibitors  (saquinavir plus ritonavir*, darunavir plus ritonavir, fosamprenavir,  fosamprenavir plus ritonavir)Do not exceed 20 mg atorvastatin dailyHIV protease inhibitor (nelfinavir) Hepatitis C protease inhibitor (boceprevir)Do not exceed 40 mg atorvastatin daily*Use with caution and with the lowest dose necessary 
 
  Cases of myopathy, including rhabdomyolysis, have been reported with atorvastatin co-administered with colchicine, and caution should be exercised when prescribing atorvastatin with colchicine [see *DRUG INTERACTIONS*].


*LIPITOR therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).*
*Liver Dysfunction*

 Statins, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. *Persistent elevations ( > 3 times the upper limit of normal [ULN] occurring on 2 or more occasions) in serum transaminases occurred in 0.7% of patients who received LIPITOR in clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively.

*

 One patient in clinical trials developed jaundice. Increases in liver function tests (LFT) in other patients were not associated with jaundice or other clinical signs or symptoms. Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients with persistent LFT elevations continued treatment with a reduced dose of LIPITOR.


 It is recommended that liver enzyme tests be obtained prior to initiating therapy with LIPITOR and repeated as clinically indicated. There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including atorvastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with LIPITOR, promptly interrupt therapy. If an alternate etiology is not found, do not restart LIPITOR.


 LIPITOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of LIPITOR [see *CONTRAINDICATIONS*].
*Endocrine Function*

 Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LIPITOR.
 Statins interfere with cholesterol synthesis and theoretically might blunt adrenal and/or gonadal steroid production. Clinical studies have shown that LIPITOR does not reduce basal plasma cortisol concentration or impair adrenal reserve. The effects of statins on male fertility have not been studied in adequate numbers of patients. The effects, if any, on the pituitary-gonadal axis in premenopausal women are unknown. Caution should be exercised if a statin is administered concomitantly with drugs that may decrease the levels or activity of endogenous steroid hormones, such as ketoconazole, spironolactone, and cimetidine.
*CNS Toxicity*

Brain hemorrhage was seen in a female dog treated for 3 months at 120 mg/kg/day. Brain hemorrhage and optic nerve vacuolation were seen in another female dog that was sacrificed in moribund condition after 11 weeks of escalating doses up to 280 mg/kg/day. The 120 mg/kg dose resulted in a systemic  exposure approximately 16 times the human plasma area-under-the-curve (AUC, 0-24 hours) based on the maximum human dose of 80 mg/day. A single tonic convulsion was seen in each of 2 male dogs (one treated at 10 mg/kg/day and one at 120 mg/kg/day) in a 2-year study. No CNS lesions have been observed in mice after chronic treatment for up to 2 years at doses up to 400 mg/kg/day or in rats at doses up to 100 mg/kg/day. These doses were 6 to 11 times (mouse) and 8 to 16 times (rat) the human AUC (0-24) based on the maximum recommended human dose of 80 mg/day.


 CNS vascular lesions, characterized by perivascular hemorrhages, edema, and mononuclear cell infiltration of perivascular spaces, have been observed in dogs treated with other members of this class. A chemically similar drug in this class produced optic nerve degeneration (Wallerian degeneration of retinogeniculate fibers) in clinically normal dogs in a dose-dependent fashion at a dose that produced plasma drug levels about 30 times higher than the mean drug level in humans taking the highest recommended dose.
*Use in Patients with Recent Stroke or TIA*

 In a post-hoc analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study where LIPITOR 80 mg vs. placebo was administered in 4,731 subjects without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the LIPITOR 80 mg group compared to placebo (55, 2.3% atorvastatin vs. 33, 1.4% placebo; HR: 1.68, 95% CI: 1.09, 2.59; p=0.0168). The incidence of fatal hemorrhagic stroke was similar across treatment groups (17 vs. 18 for the atorvastatin and placebo groups, respectively). The incidence of nonfatal hemorrhagic stroke was significantly higher in the atorvastatin group (38, 1.6%) as compared to the placebo group (16, 0.7%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the atorvastatin group [see *ADVERSE REACTIONS*].
*Patient Counseling Information*

 Patients taking LIPITOR should be advised that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.


*Patients should be advised about substances they should not take concomitantly with atorvastatin [see WARNINGS AND PRECAUTIONS]. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking LIPITOR.*
*Muscle Pain*

 All patients starting therapy with LIPITOR should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing LIPITOR. The risk of this occurring is increased when taking certain types of medication or consuming larger quantities ( > 1 liter) of grapefruit juice. They should discuss all medication, both prescription and over the counter, with their healthcare professional.
*Liver Enzymes*

 It is recommended that liver enzyme tests be performed before the initiation of LIPITOR and if signs or symptoms of liver injury occur. All patients treated with LIPITOR should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
*Pregnancy*

 Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using LIPITOR. Discuss future pregnancy plans with your patients, and discuss when to stop LIPITOR if they are trying to conceive. Patients should be advised that if they become pregnant, they should stop taking LIPITOR and call their healthcare professional.
*Breastfeeding*

 Women who are breastfeeding should be advised to not use LIPITOR. Patients who have a lipid disorder and are breastfeeding, should be advised to discuss the options with their healthcare professional.
*Nonclinical Toxicology*

*Carcinogenesis, Mutagenesis, Impairment of Fertility*

 In a 2-year carcinogenicity study in rats at dose levels of 10, 30, and 100 mg/kg/day, 2 rare tumors were found in muscle in high-dose females: in one, there was a rhabdomyosarcoma and, in another, there was a fibrosarcoma. This dose represents a plasma AUC (0-24) value of approximately 16 times the mean human plasma drug exposure after an 80 mg oral dose. A 2-year carcinogenicity study in mice given 100, 200, or 400 mg/kg/day resulted in a significant increase in liver adenomas in highdose males and liver carcinomas in high-dose females. These findings occurred at plasma AUC (0–24) values of approximately 6 times the mean human plasma drug exposure after an 80 mg oral dose.


_In vitro_, atorvastatin was not mutagenic or clastogenic in the following tests with and without metabolic activation: the Ames test with  _Salmonella  typhimurium_ and  _Escherichia coli_, the HGPRT forward mutation assay in Chinese hamster lung cells, and the chromosomal aberration assay in Chinese hamster lung cells. Atorvastatin was negative in the _in vivo_ mouse micronucleus test.
 Studies in rats performed at doses up to 175 mg/kg (15 times the human exposure) produced no changes in fertility. There was aplasia and aspermia in the epididymis of 2 of 10 rats treated with 100 mg/kg/day of atorvastatin for 3 months (16 times the human AUC at the 80 mg dose); testis weights were significantly lower at 30 and 100 mg/kg and epididymal weight was lower at 100 mg/kg. Male rats given 100 mg/kg/day for 11 weeks prior to mating had decreased  sperm motility, spermatid head concentration, and increased abnormal sperm. Atorvastatin caused no adverse effects on semen parameters, or reproductive organ histopathology in dogs given doses of 10, 40, or 120 mg/kg for two years.
*Use In Specific Populations*

*Pregnancy*

*Pregnancy Category X*

 LIPITOR is contraindicated in women who are or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy. Lipid lowering drugs offer no benefit during pregnancy because cholesterol and cholesterol derivatives are needed for normal fetal development.  Atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy.


 There are no adequate and well-controlled studies of atorvastatin use during pregnancy. There have been rare reports of congenital anomalies following intrauterine exposure to statins. In a review of about 100 prospectively followed pregnancies in women exposed to other statins, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed the rate expected in the general population. However, this study was only able to exclude a three-to-four-fold increased risk of congenital anomalies over background incidence. In 89% of these cases, drug treatment started before pregnancy and stopped during the first trimester  when pregnancy was identified.


 Atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure based on surface area (mg/m²) [see *CONTRAINDICATIONS*, *Pregnancy*].


 In a study in rats given 20, 100, or 225 mg/kg/day, from gestation day 7 through to lactation day 21 (weaning), there was decreased pup survival at birth, neonate, weaning, and maturity in pups of mothers dosed with 225 mg/kg/day. Body weight was decreased on days 4 and 21 in pups of mothers dosed at 100 mg/kg/day; pup body weight was decreased at birth and at days 4, 21, and 91 at 225 mg/kg/day. Pup development was delayed (rotorod performance at 100 mg/kg/day and acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225 mg/kg/day). These doses correspond to 6 times (100 mg/kg) and 22 times (225 mg/kg) the human AUC at 80 mg/day.


 Statins may cause fetal harm when administered to a pregnant woman. LIPITOR should be administered to women of childbearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the woman becomes pregnant while taking LIPITOR, it should be discontinued immediately and the patient advised again as to the potential hazards to the fetus and the lack of known clinical benefit with continued use during pregnancy.
*Nursing Mothers*

 It is not known whether atorvastatin is excreted in human milk, but a small amount of another drug in this class does pass into breast milk. Nursing  rat pups had plasma and liver drug levels of 50% and 40%, respectively, of that in their mother's milk. Animal breast milk drug levels may not accurately reflect human breast milk levels. Because another drug in this class passes into human milk and because statins have a potential to cause serious adverse reactions in nursing infants, women requiring LIPITOR treatment should be advised not to nurse their infants [see* CONTRAINDICATIONS*].
*Pediatric Use*

 Safety and effectiveness in patients 10-17 years of age with heterozygous familial hypercholesterolemia have been evaluated in a controlled clinical trial of 6 months' duration in adolescent boys and postmenarchal girls. Patients treated with LIPITOR had an adverse experience profile generally similar to that of patients treated with placebo. The most common adverse experiences observed in both groups, regardless of causality assessment, were infections. Doses greater than 20 mg have not been studied in this patient population. In this limited controlled study, there was no significant effect on growth or ****** maturation in boys or on menstrual cycle length in girls [see* Clinical Studies*; *ADVERSE REACTIONS*, *Pediatric Patients* (ages 10-17 years); and *DOSAGE AND ADMINISTRATION*, *Heterozygous Familial Hypercholesterolemia in Pediatric Patients* (10-17 years of age)]. Adolescent females should be counseled on appropriate contraceptive methods while on LIPITOR therapy [see *CONTRAINDICATIONS*, *Pregnancy* and *Use in Specific Populations*, *Pregnancy*]. *LIPITOR has not been studied in controlled clinical trials involving pre-pubertal patients or patients younger than 10 years of age.

*

 Clinical efficacy with doses up to 80 mg/day for 1 year have been evaluated in an uncontrolled study of patients with homozygous FH including 8  pediatric patients [see *Clinical Studies*, *Homozygous Familial Hypercholesterolemia*].
*Geriatric Use*

 Of the 39,828 patients who received LIPITOR in clinical studies, 15,813 (40%) were  ≥ 65 years old and 2,800 (7%) were  ≥ 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older adults cannot be ruled out. Since advanced age (≥ 65 years) is a predisposing factor for myopathy, LIPITOR should be prescribed with caution in the elderly.
*Hepatic Impairment*

 Lipitor is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels [see *CONTRAINDICATIONS* and *Pharmacokinetics*].
___________________________________________________________________________________


Good luck!


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## Jillaroo (Mar 17, 2014)

_I was put on them and had side effects so went off them and they stopped , the Doctors are always trying to put me on them, the last time a few weeks back when i told him no Statins, he sat there with a smirk on his face :hit::grrr:_


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## drifter (Mar 17, 2014)

I've been on 30 mg simvestan (statin) for over a year. I have had severe leg cramps that lasts longer even after I get up. Based on what I have read on another forum, I have taken myself off statins. I do need to inform my doctor.


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## Rainee (Mar 17, 2014)

Thanks for your reply Vivjen.. I really appreciate that .. I am sure that that is what is causing a lot of my pain .. 
so will work it out some way or another.. thanks again..


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## Vivjen (Mar 18, 2014)

Rainee; sorry I have been so long....been a little busy.

Alpha-lipoid acid is a fairly strong anti-oxidant....a little like a super food.

It has been shown to help with increases in vitamin C and E, and has been shown to be useful in some degenerative eye-diseases.

It is also used by body-builders?!

Nothing has been proven yet about nerve pain, although some reports say it can be helpful; and I can't see any reason for not trying it.

Remember; you control your medicines; not the other way round!

Statins are a controversial subject; everywhere; but in my opinion, higher cholesterol is better than muscle pain and wastage; and can be controlled to a certain extent by diet....although the advice on that changes by the day!

You appear to have a good doctor.....talk over your hypertensives with her....she may have slightly different ideas; and you may get all your problems sorted, and feel better for it.....I hope so; both of you.

Take care.


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## Tom Young (Mar 19, 2014)

SifuPhil said:


> The U.S. medical profession has a long history of being the whipping boy of the pharmaceutical industry. In the '50's and '60's physicians would receive extravagant gifts, including sums of cash, to carry a specific pharmaceutical. They were basically being rewarded for being bird-dogs.
> 
> After a ruckus was raised over this practice, it went underground. Now, you cannot be a practicing physician for very long if you don't carry what your "masters" (the insurance companies) tell you to carry. So no, physicians are no longer rewarded for prescribing their drugs - now they are threatened if they do not.
> 
> From positive reinforcement to negative, all in the course of a few decades.



Interesting stuff... any time there is money involved, business will find a legal way to influence and optimize means to improving the bottom line.  
Try this link for some specifics "by state" as to how much is spent and by whom.  
Funny thing... throughout my entire career, no one outside my own corporation ever paid me to consult, to participate in a test,  or to speak. 



http://projects.propublica.org/docdollars/

In the US... If you go to this website and put in your doctor's name, you can see how much he/she has received.  Initial result may show 'zero' if the payments were under $250...
 For other benefits received... ie. lunches or other forms of remuneration less than $250... click on "See All Payments".


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## SifuPhil (Mar 19, 2014)

Fascinating and useful link, Tom - thank you so much.

Since I don't have a physician I entered the name of my town, and what an eye opener! 4 pages of doctors listed, many with multiple payments from the pharmaceutical companies for "teaching" their patients and other professionals about the drugs.

To me, that's accepting blood money.



> Funny thing... throughout my entire career, no one outside my own  corporation ever paid me to consult, to participate in a test,  or to  speak.



They probably sensed that you weren't the kind to accept it and keep quiet about it, or maybe they just ran out of funding by the time they got to your name. 

I did a bit of consulting and speaking when I was a safety manager, but there were never any conflicts of interest - I made sure of it.

Thanks again.


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## rt3 (Mar 19, 2014)

not included in SiPuPHils label insert warning is ototoxicity, degeneration of the hair cells with resulting hearing loss.

currently  CoQ10 is being tested to off set the some of the side effects, and if you have been taking or taking statins, look into this as something you may want to try


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## Warrigal (Apr 1, 2014)

OK, the experiment is completed and the GP is convinced that Lipitor is not for me.
He has now prescribed Crestor (Rosuvastin) 20mg daily.

I will be watching for side effects more carefully this time.


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## Rainee (Apr 2, 2014)

Thanks Vivjen for the reply.. my problem is I can`t take vitamin c as in tablet form or oranges as they make my system absorb too much iron so I can use rosehip or blackcurrants instead so thats what I do .. I have iron over load.. you know the medical name of it as its long to post here.. so have to watch what I take in meds and vitamins.. but I am doing what you suggest and so far going quite comfortable.. 
not a lot of pain so hope it stays that way.. interesting about statins.. my hubby is doing well on 40mg and they keep his cholesterol down better than when he was on 80mg.. that is strange isn`t it ? anyway thanks for your help its a wonderful help..


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