Summary: The FDA has put a restriction on the use of Simvastatin 80mg – it was not recalled. Patients who have had no side effects on this dose for 12 months may be able to continue taking it. If you haven’t reached the 12 month window yet there are still other options. Some of which will depend on other medications that you might be taking.
Dear Curtis: I’ve been taking Simvastatin 80mg for almost a year now and I haven’t had any problem and my cholesterol has gotten better. I went into the pharmacy to get my refill and the pharmacist told me they are going to have to switch me to something else because Simvastatin was recalled. Why would they recall it and what are people, who had good results with it, suppose to do?
Not trying to split hairs, but at the time of this writing, the 80mg strength of Simvastatin has not been recalled. It’s important for you to know the difference because too many patients think that they don’t have any options in this scenario. Truth is, you do. But, first of all, you need to understand why the restrictions were put in place.
What happened was a large scale study (called the SEARCH study) found that patients on Simvastatin 80mg had a much larger chance of developing myopathies. Myopathy is a rare type of muscle pain that can happen with any of the statin cholesterol lowering medications like Simvastatin.
Unfortunately, in the study it was clear that this side effect was popping up much more than it should have. Ultimately prompting the Food and Drug Administration to restrict the use of Simvastatin 80mg. So, it was NOT recalled. But it’s use is limited.
A New Guide for Simvastatin Dosing
If you’d like to understand your options a little better here’s a quick breakdown of what could likely happen.
- For patients who have been on Simvastatin 80mg for over 12 months with no signs of myopathy they may be able to continue to take the drug.
- For patients who have been on this dose less than 12 months it’s recommended that the dose be dropped or that a switch to another cholesterol lowering medication be made. Some examples in the same class include Lipitor, Pravachol (pravastatin) or Mevacor (lovastatin).
- Doctor’s should not prescribe more than 20 mg of Simvastatin if you are taking the blood pressure medication Norvasc (amlodipine) or the angina medication Ranexa (ranolazine).
- The dose of Simvastatin should not go above 10mg a day if you are taking Cordarone (amiodarone), Cardizem (diltiazem) or Verelan (verapamil).
- Finally, you should avoid using Simvastatin completely with any of the antifungals (like ketoconazole or itraconazole), antibiotics like erythromycin and clarithromycin, HIV Protease inhibitors, gemfibrozil, cyclosporine or nefazodone.
Not Cut and Dry
The problem that you are facing right now is that you’re in a high risk group with the dose of Simvastatin your’re taking. A doctor may be very hesitant to ‘buck’ a clear FDA warning and put him or herself at risk from something happening and being liable.
However, if you really feel like switching right now would be detrimental you actually have a case because you are close to reaching that 12 month window and you haven’t had any side effects. So your doctor may be willing to let you continue.
If you have any form of prescriptions insurance you may want to take a peek at using Lipitor. To be as effective as simvastatin 80mg you only have to take 40mg of Lipitor. But, the cash price of Lipitor is still very high so insurance is critical in this situation.
The point is it’s not as cut and dry as you may have originally thought. You have a number of options and the best one for you depends not only on you and your doctor’s discussions but also other medications that you are taking – or could possibly be taking in the near future.