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Zocor and Simvastatin Hit with New FDA Restrictions

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Washington, DCThirteen years after high-dose Zocor was approved by the US Food and Drug Administration (FDA) as a drug whose benefits outweighed its risks, the health regulator has slapped new restrictions on the drug over concern for the onset of myopathy.

Originally approved in 1991, Zocor was given the nod for an 80-milligram version in 1998. Now, the FDA is saying that no new patients should be put on high-dose Zocor. What's more, the FDA is only comfortable with existing patients continuing with 80-mg Zocor if they have successfully used the drug for at least one year without experiencing muscle pain.

Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, noted in comments published Wednesday in The New York Times that the FDA move was long overdue. "Most experts in the field have known for many years that these high doses of Zocor were not safe compared with the other statins."

Zocor is the brand name for simvastatin, a drug designed to help patients maintain optimum cholesterol levels. The patent, originally held by Merck, expired in 2006, and Zocor has been sold mostly in generic form ever since. The restrictions apply to generic Zocor as well, together with Vytorin (a joint project of Merck and Schering Plough) and Simcor, manufactured by Abbott Laboratories.

This latest move by the FDA comes on the heels of a seven-year study that mirrored patient reports received by the FDA suggesting that patients taking the higher dose of simvastatin carried a higher risk for muscle injury than those taking lower doses of that particular statin, v. other statins.

The FDA, according to The New York Times, issued a safety warning on higher-dose simvastatin in March of last year. An estimated 2.1 million Americans use either Zocor or generic simvastatin.



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you know its a shame when you have to medicine for a health problem and the same medincine turn around and give you more health problems!! i been on simvastatin for years. i take 40mg. i been having severe muscle ache and muscle spasm,tenderness,swelling more than usual.muscle ache in arms and i have numbness in my toes. i had numbness in my feet but about 2 or 3 years ago my feelings came back in my feet now i just have numbness in my toes only on my left feet.i have been having headaches on and off but when things got bad i had headache for 2 days straight and thats usual for me. i been having bad legs cramp when i'm up but mostly when i'm laying down. i have thyriod problems so i figure thats the problem.well, anyway i went to see my doctor and he told me to stop taking simvastatin for 2 weeks because he said that could be the problem.he also send me to take a test to check my legs because he could barely feel a pause.while i been waiting for my appt to take the test in the mean while i thought i remove the simv. i miss and move the ibuprofen instead it took me 2 days to realive that because 3:16 in the morning i star having the worst muscle spasm ever it was hitting from side to side and upper stomach the pain was unbearable i never felt muscle spasm like that in my life so, threw those pills in the trash.that morning and that afternoon i suffer with the pain until that night i got some relief i had to wine up taking my naproxen 500mg tablet 2 a day as needed. but, i thank god my test came out go! it could of been worse and the doctor me off of that medicine and i don't have muscle spasm but it left my left feet numb and still have aches but not severe but i have them enough and this leg keeps me agitated and i pray that god wil fix my leg so it can feel normal again its been about 5 years dealing with this.i ask the doctor wil my feet will get back right and feel normal again! he don't know! i thank god for my doctor. i'm saying all of this to say i hope and pray that the people who have more serious problem than i do can get compensate for what that medicine did to them because i know they went through hell because thats what i'm going through and they situation is more serious than mine. i'm having a difficulty with the fact that my left leg is never going to be the same. everyday my muscle in my leg is aching and don't let it be cold!! oh my god i have to put 3 pairs of socks on my foot to keep it from aching bad. i can see if i got poor circulation in my feet but i don't my test came out good. only god knows!


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