FDA Concerns About Zocor/simvastatin in the 80 mg dose

The Food and Drug Administration (FDA) announced concerns yesterday about the risk of muscle injury specifically around Zocor or generic simvastatin in the 80 mg dose.

Statins have been widely used since the 1980's for reduction of cholesterol and reduction in the occurrence of sudden deaths from cardiac arrest, heart attacks and strokes. Muscle injury is known to be an uncommon side-effect of the statins and is proportional to the potency ("strength") and dosage ("size") of the particular statin.

Simvastatin is the most potent of the generically available statins, and the 80 mg dose is the highest dose made for it.

The FDA is concerned (this link is technically worded) that the risk of muscle injury with 80 mg a day of simvastatin is higher than for comparable doses of other statins. Specifically, they are recommending that doctors not start patients on this dose, or increase patients already on lower doses to this dose.

This concern is based on a recently completed medical study comparing the effects of simvastatin in 20 mg and 80 mg doses with and without supplemental Vitamin B12 and folic acid after heart attack.

One of the findings from this study was that the risk of muscle injury with the 80 mg dose was 0.9%, and 0.02% with the 20 mg dose. Prior to this test, the risk with the 80 mg dose had been reported as 0.53%. Hence, the warning.

Please note that if you already are on simvastatin at 80 mg a day for a year or more and not having side effects (such as persistent muscle or joint pain, or weakness), there is no need of concern.

News announcements suggest switching to other medicines that are as effective as 80 mg of simvastatin. The problem with this is that the only medicines that are equally effective are Lipitor 40 mg and Crestor 20 mg. Neither of these is generic, so they are often much more expensive.

If you would like us to switch you to one of these, let us know. Please check your insurance formulary to see which of these you would prefer so you can let us know which one to switch you to.

Statins: "I heard cholesterol pills are bad for you!"

"Statins" are the most commonly prescribed cholesterol lowering medications, and have been around since the 1980's. The first four are now available generically, and were originally developed based on naturally occurring plant-based compounds. Lipitor was ground-breaking in the mid-1990's because it was more potent ("stronger") and mainly because it was completely synthetic in origin. Crestor followed in the same manner.

They are called "statins" because the chemical names all end in -statin: lovastatin, atorvostatin, pravastatin, etc., etc.

Concerns about rare but severe side-effects in news and magazines fail to make clear the extent of any risks and benefits in taking statins.

Downsides:

• Flatulence (passing gas) is actually the most common side-effect. Not harmful, not associated with diarrhea; just more passing gas. I have, so far, never had anyone stop taking a statin because of this.
• Liver injury. Turns out, increased liver function blood tests turn out to be from the effect that lowering your cholesterol has on allowing solidified fats in your liver to dissolve and return to normal. (so called "fatty liver") This is not a toxic effect on your liver. Unfortunately, warnings that go on drug labels rarely ever go off them.
• Muscle injury. Actual toxic injury to muscle is rare with statins. Rare as in 10-25 times per 10,000,000 (10 million) prescriptions written. That's 1-2.5 in a million. Your chances of being struck dead by lightning are about 1 in 5,000. Please, let's put that in perspective.
• Muscle aching. Here, were talking achiness that is not harmful, and goes away within a few days of stopping the medication. This occurs in about 4% of folks. Mind you, this comes from studies showing 21% of people taking a statin complain of achiness, but 17% of people taking a sugar pill (placebo) do, too. The human mind is a funny thing...

Upsides:

• Reduced risk of heart attack or cardiac arrest by about 31-34%.
• Similarly reduced risk of stroke.
• Reduced risk of Alzheimer's dementia.
• Reduced risk of colon cancer.
• Reduced risk of osteoporosis.

Short story:

• Statins can make you pass gas more often, but can't hurt your liver. Muscle aching is uncommon and actual muscle injury is extremely rare.
• They do reduce you risk of heart attack, stroke, Alzheimer's, colon cancer and osteoporosis.