Adverse Effects
Common side effects (>1% incidence) may include abdominal pain, diarrhea, indigestion, and a general feeling of weakness. Rare side effects include joint pain, memory loss, and muscle cramps. Cholestatic hepatitis, hepatic cirrhosis, rhabdomyolysis (destruction of muscles and blockade of renal system) and myositis have been reported in patients receiving the drug chronically.
A type of DNA variant known as a single nucleotide polymorphism (SNP) may help predict individuals prone to developing myopathy when taking simvastatin; a study ultimately including 32,000 patients concluded the carriers of one or two risk alleles of particular SNPs were at a five-fold or 16-fold increased risk, respectively.
On June 8, 2011, the U.S. Food and Drug Administration (FDA) announced new safety recommendations for high-dose simvastatin (80 mg) due to muscle injury risk.
In March 2012, the FDA updated its guidance for statin users to address reports of memory loss, liver damage, increased blood sugar, development of type 2 diabetes, and muscle injury. The new guidance indicates:
- FDA has found that liver injury associated with statin use is rare but can occur.
- The reports about memory loss, forgetfulness and confusion span all statin products and all age groups. Egan says these experiences are rare but that those affected often report feeling “fuzzy” or unfocused in their thinking.
- A small increased risk of raised blood sugar levels and the development of type 2 diabetes have been reported with the use of statins.
- Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain.
This advice has caused some controversy, and claims have been made that it is too conservative in its guidance regarding diabetes. In March 2012, Dr. Eric J. Topol, the Chief Academic Officer for Scripps Health and Director, Scripps Translational Science Institute, published an op-ed piece in the New York Times entitled 'The Diabetes Dilemma for Statin Users' claiming the trial data had been misunderstood and the risk of diabetes amongst users of simvistatin, atorvastatin, and rosuvastatin was much higher.
Read more about this topic: Simvastatin
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