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Statin Side Effects: From Muscle Soreness to Rhabdomyolysis

By | Adverse Drug Reactions, Statins | No Comments

Statins are drugs used to lower cholesterol. They are effective agents for treating high cholesterol, enabling your liver to remove cholesterol from your blood, which lowers your total cholesterol. Lowering LDL (low-density lipoprotein, or “bad”) cholesterol results in substantial reductions in cardiac events. Statins also help prevent other cardiovascular diseases, such as chest pain, heart attacks, strokes, and certain blood vessel problems (Pharmacy Times “Statins Provide Heart Benefits Besides Cholesterol Lowering” June 1 2017).


Statins approved for use in the United States include the following agents: atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), and pitavastatin (Livalo).

One of the most common unwanted symptoms from taking statins is muscle pain, muscle soreness, muscle fatigue, and muscle weakness. People who take statins shouldn’t drink large quantities of grapefruit juice, as this is associated with the muscle pain side effects. Statins may affect specific enzymes present in muscle cells that are responsible for muscle growth. The muscle pain is located in skeletal muscle, and the side effects range from slight myalgia to severe rhabdomyolysis.


Rhabdomyolysis: Rapid Breakdown of Skeletal Muscle

Rhabdomyolysis is a serious condition in which the destruction of striated muscle tissue, or skeletal muscle, releases muscle enzymes such as myoglobin and electrolytes from inside the muscle cells. If you have too much myoglobin in your bloodstream it can cause kidney damage. If treated early, rhabdomyolysis may be stopped.   This condition is treated with fluids given in an IV drip. Some people may require dialysis or hemofiltration (therapy filtering bad waste and products from blood) to address the more severe cases.

Early symptoms of rhabdomyolysis may be vague as they are not specific and may mimic other conditions. The symptoms of rhabdomyolysis include:


  • Muscle weakness
  • Fatigue
  • Low urine output
  • Bruising/soreness
  • Dark or tea-colored urine
  • Infrequent urination
  • Fever
  • Malaise (discomfort)
  • Nausea/vomiting
  • Confusion
  • Agitation

Although only a minimal number of people get rhabdomyolysis, many people take these medications and it is important to be aware of the risks.


Importance of Determining Muscle and Kidney Health

There are several tests to check muscle and kidney health. Creatine kinase levels should be tested, as it is an enzyme found in the skeletal muscles, the brain, and the heart. Myoglobin levels in the blood and urine should also be tested, as myoglobin is a protein that is a byproduct of muscle breakdown. Potassium is an important mineral that may leak from injured muscles and should be tested as well. Lastly, creatine in blood and urine should be tested, as creatine is a breakdown product created by muscle that is normally removed from the body by the kidneys.

Rhabdomyolysis can be successfully treated without long-term damage to the kidneys if it is treated early. Fluid recovery is essential and is the first and most important treatment.


Statin Muscle Side Effects and Pharmacogenetics

Although few patients experience muscle pain and the associated serious side effects, it has been suggested that the basis for this reaction is genetic. Once the human genome was sequenced and completed, the field of pharmacogenetics could advance its knowledge base. Pharmacogenetics is an important medical field that studies the genes that are responsible for drug metabolism and related events. Advances in the wider field of pharmacogenomics showed that in a genome wide study, muscle myopathy was associated with single nucleotide polymorphisms (SNPs) in the gene SLCO1B1. Those authors identified common genetic variants in SLCO1B1 that are strongly associated with statin-induced myopathy.


Know Your Risks with the Rxight® Pharmacogenetic Test

Genotyping using the Rxight® pharmacogenetics test from MD Labs may help patients receive the benefits of statin therapy without the muscle-associated side effects. Pharmacogenetics testing with the Rxight® platform from MD Labs is an advanced, state-of-the-art method to test many gene variations in your individual genome that may be responsible for adverse effects with statins and over 200 other drugs on the market. This precision medicine approach to personalized care is now available by prescription.

Ask your physician to prescribe the Rxight® pharmacogenetics test from MD Labs. You and your physician may use these results over the lifetime of your care, as many genes are tested for variations that are responsible for adverse side effects not only in statins, but also in the majority of drugs on the market.

These results inform your physician about what drugs you may safely take, and what drugs are not recommended for you, in addition to giving dosing schedules that might be different from label instructions. Participating in this precision medicine advance may lead to lessened side effects over the course of your lifetime pharmaceutical treatments.



statins side effects

Statin Side Effects in Women

By | Drug Metabolism, Pharmacogenetic Testing, Pharmacogenomics, Precision Medicine, Statins | No Comments

Statin treatment in women without cardiovascular disease is controversial. Research has found that for women with elevated LDL levels as their only cardiovascular risk factor, the benefit of lowering LDL cholesterol with a statin drug might not outweigh the risks.
According to an article in Circulation “Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia” (March 2010) many women take statins and suffer side effects similar to those experienced by men. Statin side effects range from mild to severe and include liver damage, myopathy, and behavioral and cognitive problems.

Revised Treatment Guidelines Push for Increasing Statin Use

Treatment guidelines issued in 2014 in the New England Journal of Medicine suggest that up to 13 million more adults should be taking statins. The revised guidelines changed the focus from specific cholesterol levels to a wider assessment of heart attack and stroke risk.

Opponents Claim Too Many Women Prescribed Statins

Not everyone agrees with these new treatment guidelines, as reported in the New York Times, also in 2014: “Among men 60 to 75, the percentage would jump to 87 percent from 30 percent; among older women, it would increase to 54 percent from 21 percent.” In that New York Times article, the chief of cardiovascular medicine at the Cleveland Clinic said the report confirmed his concerns that the new guidelines “don’t target the right patients for treatment.” He faulted the study for not taking into account the family history of cardiovascular disease: “Should so many women be taking statins? Far too many healthy women are taking statins, they say, though some research indicates the drugs will do them little good and may be more likely to cause serious side effects in women.”

Women Found to Suffer More Side Effects from Statins Than Men

These studies highlight the fact that fewer women take statins than men, and that women suffer more side effects from statins than men. Although women represent about half the population, they are enormously under-represented in clinical trials of statins. It follows that the evidence on the benefits and risks for women is scarce. In one of the studies American Journal of Cardiology “Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER)” (Jan 2006), there was no significant reduction in heart attacks, strokes and deaths among the women while the male participants on statins had fewer heart attacks and strokes.

Weigh the Risks and Benefits with Genetic Testing

Some side effects of statins and other drugs may be reduced by either altering the dose or by changing the particular statin prescribed. Side effects in general may be reduced by taking into account the variation in your drug metabolism genes. The study of variation in the drug metabolism genes defines the field of Pharmacogenetics. This advanced genomics field emerged after the human genome was sequenced and has become an important field of its own.

Rxight® Pharmacogenetic Testing for Statin Side Effects

Pharmacogenetics research showed there is variation in the genes that are responsible for processing drugs. That means that if a particular gene has variations it may result in a gene product (protein or enzyme) that is non-functional or has reduced function. This altered function, which can sometimes mean an inability to process a medication or a reduced ability to process a medication, may result in adverse side effects. Side effects may be lessened by avoiding those drugs that you don’t have the ability to process normally.

Once you and your physSician have these results you can use them for your lifetime. The results allow your physician to interpret your ability to metabolize over 200 drugs on the market. Your physician will then have at hand the predictive ability to prescribe drugs that are safer for you and to possibly avoid side effects with any new medication. With the Rxight® pharmacogenetic test from MD Labs you can bring precision medicine home to your personalized medical care.

pgx testing

Researchers at Vanderbilt University Call for Pre-emptive Genetic Testing in CVD Patients

By | Other, Pharmacogenetic Testing, Pharmacogenomics, Precision Medicine, Provider, Statins | No Comments

Cancer and cardiac patients are typically prescribed multiple medications due to the severity and clinical complexity of their illness. It has been proposed in numerous studies citing relevant data on statistically significant adverse medication reactions in this population that pharmacogenetic testing should be conducted pre-emptively on such groups to prevent adverse clinical outcomes.
Researchers at Vanderbilt University Medical Center’s Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment (PREDICT) investigated gene variants that were deemed clinically actionable based on institutionally approved clinical decision support advisors for five common DGIs (drug-gene interactions) in a clinical group of 10,044 cardiovascular disease (CVD) patients, as detailed in a January 2017 article in Pharmacogenomics and Personalized Medicine “Prevalence of clinically actionable genotypes and medication exposure of older adults in the community.”
The study analyzed clinically actionable pharmacogenotypes for clopidogrel, warfarin, statins, thiopurines, and tacrolimus. The researchers reported that 91% of patients had at least one actionable gene and more than 5% of patients were at high risk of suffering strong adverse reactions. Similar studies corroborate the PREDICT researchers’ findings, according to the article.
Pre-emptive genetic testing should therefore be integrated into standard care models, the researchers concluded. Given the preponderance of data on DGIs such as these, the investigators called for prescribers to give greater consideration to the possibility of clinically relevant drug-gene interactions in the older adult group. “Our findings affirm that pre-emptive genotyping is likely to have strong potential to improve medication safety, efficacy, and health outcomes,” the article stated. “Further investigations correlating genotypes and medication exposures to adverse reactions and other outcomes in older people appear justified.”

Side Effects of Statins

Cognitive Side Effects of Statins

By | Adverse Drug Reactions, Statins | No Comments

A small percentage of statin users have reported that they experienced memory loss, forgetfulness, and confusion while taking the medication.  There are a wide variety of side effects of statins, however, the general consensus among physicians is that the benefits outweigh the risks of statin prescriptions.

Degrees of Cognitive Impairment

Studies seem to focus on the differing properties of statins. According to Journal of Pharmacovigilance Examination of the FDA Warning for Statins and Cognitive Dysfunction (Sept 2004) : “Statins can be classified as having greater lipophilic or hydrophilic solubility properties with lipophilic statins more readily crossing the blood brain barrier, and possibly differentially inducing detrimental cognitive effects…Highly lipophilic statins with specific pharmacokinetic properties (atorvastatin, simvastatin) appear to confer a significantly greater risk of adverse cognitive effects compared to other lipophilic statins and those with hydrophilic solubility properties.”
Another study in the Journal of General Internal Medicine Do Statins Impair Cognition? A Systematic Review and Meta-Analysis of Randomized Controlled Trials (Mar 2015), found the opposite effect. Statin therapy was not associated with cognitive impairment in RCTs (randomized clinical trials). These results raise questions regarding the continued merit of the FDA warning about potential adverse effects of statins on cognition.
Whatever the conclusions of investigators, it is true that memory adverse events have been reported to the FDA.  While the percentage of people affected is likely small, it is an effect that may be serious to the patient experiencing memory loss and result in non-compliance.

Understand Your Risk for Side Effects with the Rxight® Genetic Test

There are many statins on the market, implying that memory side effects may be lessened by reducing the dose of the statin, or changing the statin that you take.  This trial and error approach to prescribing medicines may become a thing of the past with the emerging field of pharmacogenetics.  Pharmacogenetics research demonstrated that among the population, there are many genetic variants of genes involved in drug metabolism or related activities such as drug transport and drug targeting.

How Does Pharmacogenetic Testing Work?

The Rxight® pharmacogenetic testing from MD Labs is a state-of-the-art platform that determines your drug metabolism genetics for you and your physician over the lifetime of your association with that physician.  This test not only determines your genetic variations with respect to statin metabolism, but with respect to over 200 drugs on the market.  You could talk with your physician any time you need a new medication to check your genetic status in regards to that drug.  In time, tools such as the Rxight® pharmacogenetics test from MD Labs, will become common and the era of trial and error prescribing will cease to exist.   








About Statin Myopathy

By | Adverse Drug Reactions, Drug Metabolism, Statins | No Comments


What are Statins?

Statins are the primary class of lipid lowering medications used to lower serum cholesterol for both primary and secondary prevention of coronary disease.  They inhibit the enzyme HMG-CoA reductase which plays a central role in the production of cholesterol. Statin therapy is successful in reducing cholesterol and thus, limiting the incidence of cardiovascular events.


Myalgia, Myositis, Rhabdomyolysis

Statin myopathy is separated into three different types based on toxicity such as myalgia, myositis and rhabdomyolysis.  Myalgia refers to generalized pain in the muscles, while myositis presents itself with muscle pain, tenderness, weakness and a higher blood level of creatine kinase.  Rhabdomyolysis is an extreme, life threatening type of myopathy.  Myalgia can occur with or without serum creatine kinase elevation, a marker for muscle damage.  Myositis has a higher level of creatine kinase in the bloodstream.  The most extreme, life-threatening type of myopathy, rhabdomyolysis, can display up to 10 times greater creatine kinase levels.  This can be fatal due to acute renal failure.


What Causes Statin Myopathy?

The way in which statin myopathy occurs is not well understood.  Statins are HMG-CoA reductase inhibitors and prevent the conversion of HMG-CoA to mevalonic acid, an early step in cholesterol biosynthesis.  Individual statins may have specific effects on the synthesis of coenzyme Q10, which plays an important role in muscle cell energy production.  Conflicting studies have come to different conclusions about whether statins decrease the levels of ubiquinone in skeletal muscle. The jury is still out on what exactly causes statin myopathy adverse effects, but many studies are focusing on additional genes and proteins involved in lipid metabolism. Most statins undergo CYP3A4-mediated biotransformation, and variations in this gene may be responsible for statin muscle myopathy.


Statin Myopathy and Pharmacogenetic Testing

Once the human genome was sequenced, pharmacogenomics emerged in the form of genome wide association studies, which showed that many people have gene variations that are responsible for medication adverse reactions.  Testing is available from MD Labs with the Rxight®  pharmacogenetic testing.  All that is required is a prescription from your physician to see your pharmacist for a cheek swab.  The results may be used by you and the prescriber over the lifetime of your individual care, as the test determines your genetic variations with respect to drug metabolism for over 200 drugs.








The Many Potential Side Effects of Statins

By | Adverse Drug Reactions, Statins | No Comments

“Statins” are the term that describes a group of cholesterol medications that all work in the same way (i.e. they are all in the same drug class; namely HMG-CoA reductase inhibitors. Because all statins work the same way, they all cause the same side effects, collectively called “statins side effects.” The statins side effects range from minor to severe, even life-threatening. Thus, anyone on a statin medication or thinking about starting on should be aware of statin side effects.

How Do I Know if I am Taking a Statin?

Fortunately it is fairly simple to determine if you are taking a statin. The generic name of each statin drug ends with the suffix –statin. The brand name for each drug with not have the statin suffix, but the generic name will be included with the brand name on your prescription information. To make sure, here is a list of statins:
• Atorvastatin
• Cerivastatin
• Fluvastatin
• Lovastatin
• Mevastatin
• Pitavastatin
• Pravastatin
• Rosuvastatin
• Simvastatin
• Combination drugs that contain one of the statins listed above plus another medicine

What are the Side Effects of Statins?

Statin drugs are generally safe and free from side effects, especially compared to other cholesterol medications. That being said, statins are known to cause the following side effects in a fraction of those who take the drugs:
• Elevated liver enzymes/liver injury
• Muscle injury (statin myopathy)
• Kidney problems
• Behavioral problems
• Cognitive problems/problems with thinking and concentrating
• Diabetes mellitus (intensive statin therapy may worsen diabetes)
• Peripheral neuropathy
Because of risks to the fetus and breastfeeding newborn, statin drugs should not be taken during pregnancy or while breastfeeding.

Statin Myopathy


Statins commonly affect the muscles in some way, usually causing soreness, but sometimes causing damage. Muscle injury caused by statins is called statin myopathy. Minor statin myopathy causes muscles achiness and soreness (myalgia) and perhaps muscle weakness. Muscle inflammation may also occur. In serious cases, statin myopathy causes muscle cells do die and release their contents into the blood stream (i.e. rhabdomyolysis). These contents can, in turn, injure the kidneys and lead to renal failure.
Fortunately, most muscle-related statins side effects are mild and can be fully reversed by stopping treatment. On the other hand, it is important to notify your doctor if you experience new or worsening muscle aches after starting a statin drug. The drug may need to be stopped or some statin drugs are less likely to cause statin myopathy than others are.

Liver Problems from Statin Use

Up to 3% of people who take statins develop elevated liver enzymes. Elevated liver enzymes are a sign that the liver is being injured in some way. A brief, mild elevation in liver enzymes can come from relatively minor things, like drinking alcohol or eating a fatty meal. The same may occur from statins, which is not a problem. However, if the liver enzymes increase substantially (i.e. ALT reaches three times the upper limit of normal), a change in medication should be considered (and should resolve the problem).

Behavioral and Cognitive Problems from Statins

In rare cases, statins may be the cause of potentially several behavioral and cognitive problems. There have been some reports of people experiencing problems with memory, irritability, aggression, and depression. These statins side effects are rare, but if they occur, they are very important to the patient and the patient’s family. While the benefits of statins far outweigh the risks in most people, it is important to be aware of statins side effects and discuss them with your doctor.

Understand Your Risks with the Rxight® Genetic Test

The Rxight® genetic test evaluates your unique genetic reaction to many statins, to identify  potential medication side effects or non-response.  Rxight® performs this test along with many other genes involved drug action and metabolism to provide a strong clinical picture of a patient and warn those who would have a serious and potentially fatal adverse drug reaction.