Simvastatin 80mg Side Effects
Simvastatin is a cholesterol lowering medication belonging to the "statin" family (which also includes drugs like lovastatin and pravastatin). The brand name for simvastatin is Zocor, although other prescription medications also contain simvastatin, such as Vytorin and Simcor.
In June of 2011 the FDA issued a warning for doctors to not start patients on the highest dose (80mg) of simvastatin due to concerns over side effects which I am going to review in this article. Simvastatin is available in lower dosages, namely 5mg, 10mg, 20mg and 40mg tablets.
Although the FDA recommendations were issued in 2011, many insurance companies are now beginning to actually BLOCK access to 80mg simvastatin for patients, and this is creating a variety of questions. In this article I will explain the reason for the concerns with 80mg simvastatin and what to do if you are concerned.
As always, do not attempt to change your dosage of medication without first talking to your doctor. The information which follows provides a quick summary of the facts about simvastatin 80mg for patients and health care providers. Nothing in this article is intended to imply you should change your current medication.
Actual Warning as Printed in Zocor (simvastatin) literature:
Simvastatin and the SEARCH study
Medical studies are typically given clever names, which are usually acronyms of some sort. This study, called the SEARCH study, stood for "Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine." This was a large study of over 12,000 patients and compared simvastatin 20mg and simvastatin 80mg, along with several vitamins and placebo controls. A summary of the study results can be found HERE. Amongst the study results were a total of 52 patients who developed myopathy while taking the 80mg dose (compared to just 1 taking the 20mg dose) and 22 patients who developed rhabdomyolysis (compared to none in the 20mg group). Allow me to define these 2 conditions for you.
1. Myopathy: This can be defined as "an abnormal condition of skeletal muscle characterized by muscle weakness, wasting, and histologic changes within muscle tissue." Myopathy is a general term. When this occurs as a result of statin drugs, it is often referred to as "toxic myopathy." Symptoms of myopathy, resulting from statins, include:
- Difficulting rising and standing, particularly from low seated chairs
- A gradual onset of weakness, often developing slowly over several months
- Difficulty swallowing
- Pain around the torso area
- General muscle pain/aches
2. Rhabdomyolysis: This is a more serious condition resulting from the breaking down of muscle tissue resulting in the release of myoglobin into the blood stream which may lead to kidney damage. Many different things can cause rhabdomyolysis, including certain illegal drugs, alcoholism, seizures and severe exertion. Symptoms include:
- Abnormal urine color (dark or reddish)
- General weakness or fatigue
- Muscle tenderness & joint pain
Diagnosis requires taking blood tests and/or a urinalysis
In order to help patients who may have questions about simvastatin 80mg, Merck has developed a website that answers some of the frequently asked questions about the use of high dose simvastatin (they are the makers of the brand name Zocor and Vytorin). You can access this website here: The Simvastatin Info Center
Cholesterol Lowering Literature
Pharmacist Advice about Simvastatin
These new recommendations have some patients asking about the safety of using simvastatin, and other statins, to reduce their cholesterol. The following is some of the general advice I give to those wondering about the use of statins:
1) Numerous studies confirm the benefits of lowering LDL ("bad") cholesterol, and statin therapy is the most effective means we currently have to do so. Heart disease remains the number 1 cause of death. To quote from the summary of the "SEARCH" trial (mentioned above): "This new work reinforces the fundamental importance of lowering LDL cholesterol as much as we can in our fight against heart disease and strokes."
2) Normal doses of statins are generally well tolerated. For more general information on statin drugs, see my article: What are Statins?
3) If you are currently taking simvastatin 80mg and have been on it for over 1 year, the likelihood of the above mentioned side-effects are pretty low. Myopathy and rhabdomyolysis were more common in those newly starting this dose.
4) Avoid large quantities (more than 1 quart) of grapefruit juice while taking simvasatin. Also, be sure to let your doctor know you are taking this medication before you are prescribed any other medication, as other medications may require a reduced dosage of simvastatin (e.g. Sporanox, erythromycin, clarithromycin, verapamil, diltiazem, amiodarone).
5) Take simvastatin in the evening, unless otherwise instructed.
I hope the above information has helped answer your questions about the recently published concerns with simvastatin 80mg. If you have any other questions, feel free to ask them below. Best wishes!