FDA restricts use of simvastatin 80 mg

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freckles1880
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FDA restricts use of simvastatin 80 mg

Post by freckles1880 » June 8th, 2011, 5:01 pm

http://www.theheart.org/article/1236231 ... eakingNews

FDA restricts use of simvastatin 80 mg
JUNE 8, 2011 | Michael O'Riordan
Silver Spring, MD - The Food and Drug Administration is recommending that physicians restrict prescribing high-dose simvastatin (Zocor, Merck) to patients, given an increased risk of muscle damage [1]. The new FDA drug safety communication, issued today, states that physicians should limit using the 80-mg dose unless the patient has already been taking the drug for 12 months and there is no evidence of myopathy.
"Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug," the agency states.
In addition, the FDA is requesting that additional changes be made to the drug's label. The label will be changed to include the new dosing recommendations, as well as warnings not to use the drug with various medications, including itraconazole (Sporanox, Jannsen Pharmaceutica), ketoconazole (Nizoral by Ortho-McNeil Pharmaceutical), posaconazole (Noxafil, Merck), erythromycin, clarithromycin, telithromycin (Ketek, Sanofi-Aventis), HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, and danazol.
In addition, the 10-mg dose should not be exceeded in patients taking amiodarone, verapamil, and diltiazem, and the 20-mg dose should not be exceeded with amlodipine (Norvasc, Pfizer) and ranolazine (Ranexa, Gilead).
The changes to the label are based on the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), a study reported by heartwire. In that trial, 52 patients taking the 80-mg dose developed myopathy compared with one patient treated with the 20-mg dose. In addition, 22 patients treated with the high dose of simvastatin developed rhabdomyolysis compared with none treated with the 20-mg dose.
The FDA notes that the risks of myopathy and rhabdomyolysis were highest in the first year and that older age and female sex increased the risks.
In statement released today following the FDA alert [2], Merck notes that it has launched a new information website and is encouraging patients who think the prescribing changes might affect them to speak with their doctors.
Dr Steven Nissen (Cleveland Clinic, OH), who wrote an editorial accompanying the 2004 publication of the A to Z trial, a study that tested high-dose simvastatin in acute coronary syndrome patients, who was critical of the high rate of myopathy in that study, called the FDA decision "appropriate" but said it comes late.

"Most knowledgeable lipid experts stopped administering the 80-mg dosage of simvastatin years ago," he said in an email to heartwire. "Unfortunately, once again the FDA has been too slow to react to a serious drug safety problem. We currently have more than two million Americans taking an unsafe dosage of simvastatin when there are safer alternatives. I'm glad the FDA acted but wish they hadn't taken so long."
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 54+ years and my daughters.

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Re: FDA restricts use of simvastatin 80 mg

Post by Jim and Sparky » June 8th, 2011, 6:31 pm

You made me run upstairs and check, but I realize that I am taking a 40mg version. Whew, I guess.
MI 1/21/11; SCA's 2/3/11 and 2/4/11
I have a Boston Scientific Teligen ICD and a Boston Scientific Promus stent,
I guess my cardiologist is sort of a BS kind of guy.

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1) Don't sweat the small stuff!
2) It's all small stuff!


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Re: FDA restricts use of simvastatin 80 mg

Post by JoeNH » June 8th, 2011, 9:31 pm

Jim and Sparky wrote:I realize that I am taking a 40mg version. Whew, I guess.
You ran to check ? Take a look at my Rx list below. You'll see that I AM taking 80 mg Lipitor. I had to scramble to find the generic name for Lipitor.

I'm relieved .... the "generic" Lipitor = Atorvastatin

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Re: FDA restricts use of simvastatin 80 mg

Post by mrag » June 9th, 2011, 8:01 am

Joe...the generic name for Lipitor is MONEY. I switched some time ago from Lipitor ($250) to Simvastatin ($40) because I wanted to help control the growing costs of Medicare and I was eating dog food to pay for it. Number's wise, my cholesterol levels have remained about the "same" since switching and I didn't notice any changes in 'side effects' (although I'm not the best in picking up those patterns).

Lipitor I think becomes available as a generic in November 2011.

Interesting (short and now 'outdated'?) blurb on Lipitor vs Simvastatin at:
http://www.mayoclinic.com/health/lipito ... or/AN01722

The "old rule" was to double your dose of Lipitor to equal Simvastatin. If on 20 mg Lipitor, take 40 of Simvastatin. I was on 40 of Lipitor and went to 40 of Simvastatin and things remained fine.
"The greatest enemy of knowledge is not ignorance, it is the illusion of knowledge" S Hawking

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Re: FDA restricts use of simvastatin 80 mg

Post by freckles1880 » June 9th, 2011, 8:11 am

mrag wrote:Joe...the generic name for Lipitor is MONEY. I switched some time ago from Lipitor ($250) to Simvastatin ($40) because I wanted to help control the growing costs of Medicare and I was eating dog food to pay for it. Number's wise, my cholesterol levels have remained about the "same" since switching and I didn't notice any changes in 'side effects' (although I'm not the best in picking up those patterns).

Lipitor I think becomes available as a generic in November 2011.

Interesting (short and now 'outdated'?) blurb on Lipitor vs Simvastatin at:
http://www.mayoclinic.com/health/lipito ... or/AN01722

The "old rule" was to double your dose of Lipitor to equal Simvastatin. If on 20 mg Lipitor, take 40 of Simvastatin. I was on 40 of Lipitor and went to 40 of Simvastatin and things remained fine.
One way to cut your Lipitor cost almost in half is to take a double strength pill every other day. In the USA a 90 (90 pills) day supply of 80 mg is just a couple of dollars high that 90 pills of 40 mg. Thus the 80 lasts you 180 days by going every other day. My wife's MD is great with this, my EP is not sure every other day is best. This is one pill the pharmacist says DON'T cut in half. My numbers are very good going with the every other day. I am awaiting November 2011 for the generic already vaailable in most of the world.wavhi
Bob

Medtronic-Visia AF implanted 7-8-2016 stayed with the with 6947 Sprint Quattro Secure lead. Original ICD implant 2-4-2009. ICD turned off 10-6-17 as stage 4 lung cancer taking over.
Major heart attack, carcinogenic shock and quad bypass 10-13-08 post myocardial infarction, old inferior MI complicated by shock and CHF, combined, Atherosclerosis, abdominal aortic Aneurysm, Seroma 7 cm, left leg. Stent in the left main vein 10-7-2014

My "Wardens" are my bride of 54+ years and my daughters.

JoeNH

Re: FDA restricts use of simvastatin 80 mg

Post by JoeNH » June 9th, 2011, 10:20 am

mrag wrote:Lipitor I think becomes available as a generic in November 2011.
Al,

You are correct. Lipitor looses it's patent protection in November. We'll obviously see a major price drop shortly thereafter.

I agree with you about the cost issue. The Lipitor AIN'T CHEAP. But I've done so well on the Lipitor, both from the perspective of clinical results .... my TOTAL cholesterol is under 100 ..... and I'm have ZERO problems with side effects ..... that I decided I didn't want to change to something less expensive and was willing to swallow the outrageous cost through the end of this year, for the sake of continuing to do well on it.

Lianachan

Re: FDA restricts use of simvastatin 80 mg

Post by Lianachan » June 9th, 2011, 11:57 am

Very interesting, thanks. I have been on 40mg Simvastatin for 6 years, I was dropped down to 20mg whilst I was on Amiodarone recently and when I came off it put back on 40mg.

Ulric

MichaelP

Re: FDA restricts use of simvastatin 80 mg

Post by MichaelP » June 10th, 2011, 1:16 pm

Great post, thanks! I have been on 80mg daily for a year now with no issues. I see my cardiologist in a month, so I will ask him about staying or switching to something else.

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Re: FDA restricts use of simvastatin 80 mg

Post by gijss » June 10th, 2011, 2:45 pm

Last year when in hospital it was decided I should use something for cholesterol and I had 1 (one ) tablet simvastatin. Next morning EP came by on morning tour & asked how I was. I said 'OK but all my muscles hurt'. He turned to the nurse and said 'Switch to Lipitor'.
Now I understand why ...
My name is Gijs but in English you can call me Gilbert as this might be easier te remember :-)

SCA Nov 13, 2004, shocked Sep 2 (2x) & 5 2005, Dec 31 2005, May 20 2006, Dec 29 2008, Oct 31 2009 and April 6 2010 (3x). 'Repaired' by epicardial ablation April 16th, 2010.
First ICD Guidant Vitallity, second (May 16, 2012) Boston Scientific Energen ICD

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Re: FDA restricts use of simvastatin 80 mg

Post by myred » June 13th, 2011, 5:33 am

Hey everyone, it's been a while. Yeah that's me on 80 mg Simvastatin. I have been on it for two years now and dealing with the muscle thing. My sore muscles usually clear up a few hours after I take it.

Don
If you think things can’t get worse it’s probably only because you lack sufficient imagination.

Major heart attack. Diagnosed with CAD and Cardiomyopathy 5/28/2009.
5 stents installed 5/28/2009
2'nd heart attack. 2 stents installed 5/16/2012
EF low 15%. Seen as high as 40%. Currently about 30.
Stage C/3 CHF
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Re: FDA restricts use of simvastatin 80 mg

Post by mrag » June 13th, 2011, 8:04 am

Can you be more specific about this "muscle soreness?" Like where, what muscles. Is it something you notice only in the morning. Every few months my lower back will be very painful and I've been getting a pain in my hip with a little walking. I'm pretty sure it's nerve related (compressed disk) damage, but I'm looking to blame something else that would seem easier to fix-like take a different pill ;-)
"The greatest enemy of knowledge is not ignorance, it is the illusion of knowledge" S Hawking

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Re: FDA restricts use of simvastatin 80 mg

Post by myred » June 13th, 2011, 9:52 am

Since I wrote that post, I have read that one of the worst combo's you can be on is Zocor 80 and niacin. Well, I am on Simvastatin (Zocor) 80 and Niaspan 1000. Each pill once daily. I take them with my "night meds". I take my night meds with a full stomach and try and take them within 30 minutes of going to bed. Wen I wake up, both my leg and arm muscles are sore. I work it off and that takes about an hour or so. However, my back muscles start hurting with minimal movement. Mostly my shoulders. If I walk a quarter mile the pain goes down into both my arms. Irony is when your doc says these meds will help you and to exercise, but the meds you are taking is making it almost impossible to exercise...... Go Figure. I always thought that it was the meds and not my heart condition. Guess I have proof now.

Don
If you think things can’t get worse it’s probably only because you lack sufficient imagination.

Major heart attack. Diagnosed with CAD and Cardiomyopathy 5/28/2009.
5 stents installed 5/28/2009
2'nd heart attack. 2 stents installed 5/16/2012
EF low 15%. Seen as high as 40%. Currently about 30.
Stage C/3 CHF
BS Teligen E102 ICD 8/28/2009. Became defective and replaced with a BS E141 in May of 2015.
Married to Kim for 31 years, my best friend, my caretaker, my love, my life.

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Re: FDA restricts use of simvastatin 80 mg

Post by RUHLEN » June 13th, 2011, 12:55 pm

mrag wrote:Can you be more specific about this "muscle soreness?" Like where, what muscles. Is it something you notice only in the morning. Every few months my lower back will be very painful and I've been getting a pain in my hip with a little walking. I'm pretty sure it's nerve related (compressed disk) damage, but I'm looking to blame something else that would seem easier to fix-like take a different pill ;-)
I was on Crestor and earlier this year starting having a pain that started in my left hip and left buttock and eventually went down my leg. This was with minimal activity and would come and go. Then in March it seemed to get worse. I thought it was possibly a nerve and then one day I was in incredible pain and could not walk on the left leg. I mentioned it to my cardio doc and then went to an orthopedic sports medicine clinic as I thought I had torned the hamstring where it joins the hip at the back of the leg. It was xrayed and showed signs of some muscle damage. I was prescribedd a 1 week dosage of steroids and painkillers which seemed to help initially but the problem got worse. After research, I saw articles where other people had this problem with statins, so I called my heart doc and told him I was stopping the statins for a while. After 2 weeks, the pain was mostly gone and after 2 weeks more of a lot of walking with and without a cane, the problem was gone and has not come back. Although my cardio doc was not happy, I stressed the importance of my well being and being able to exercise. Currently, I have stopped the statins and am eating/following a LDL diet. I will make a decision on the ldl level (currently still below 100), later this summer, but am convinced the statins caused my problem.
Bob "The Chocolate Guy"
__________________________________________________________________________________________________
St. Jude Fortify CD1231-40Q implanted 10-25-2010 RVA 7121Q/65 replaced November 2017 with a new St Jude, Leaking AAA stent removed 2015 replaced with Teflon
Cook Medical Endovascular Stent 8-10-2010, Heart Attack 6-?-2010,arterial stent 6-29-2010 ef = 30

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