In this blog, we will look into one of the commonly prescribed groups of drugs called, statins. This is the group of drugs used for prevention of cardiovascular events, myocardial infarctions, strokes, etc. Currently, millions of patients in the U.S. and around the world are on statins. Most patients, to a varying degree, experience drug side effects. We will look into points that may help patients or families on statins and how to minimize adverse drug reactions. Statins are a very strong group of drugs, although beneficial is equally deleterious to the health.
- Statin drug side effects are more common in clinical practice than reported in literature and are under reported side effects to FDA.
If you are someone who takes statin drugs, learn about the list of benefits and drug side effects provided with the drug when prescribed. Look into individual symptoms that a drug side effect can be caused. If there are any new symptoms that start, which have been listed it would suggest a drug side effect. The drug side effect in the early phase is irreversible, but later may not be the case in many.
2. Self-educating, analyzing drug side effects and reporting the drug side effects to the health care professional.
Keep a log or a diary of the symptoms on a regular basis. If new symptom arises, log the severity, progression and any association of the symptoms and its onset and discuss with your healthcare professional to see if it could be a drug related side effect and can be discontinued or if there is any new onset of other disease or an exacerbation of the disease.
3. Re-appearance of drug side effect after re-start of statin drug. This is fairly common in many patients who have initially discontinued the drug. The degree and severity may vary if started on a lower dose or if there is a change of a drug made. Still, if there is a low grade of symptom starting, it still should be considered as a side effect and may affect the health.
4. Fatigue is a predominant symptom of drug side effect. Fatigue, lack of energy, decrease in overall social involvement, depression-like symptoms, sleep interruption or other sleep related symptoms are fairly common. Generally fatigue being a nonspecific symptom is generally not reported but studies have shown that fatigue is a common symptom of drug side effect. The reason for fatigue is decrease in CO-Q10 level as the statin not only decreases the cholesterol level but also decreases the CO-Q10 level as it affects the mevalonate pathway. Taking CO-Q 10 when on statin or off statin may help in reducing the statin drug side effect.
5. Common drug side effect symptoms are generally skeletomuscular and central nervous system side effect symptoms such as myalgia/muscle aches, body aches, back pain, extremity weakness, especially getting up from the toilet seat or proximal muscle weakness either in the arms or the legs, overall decrease in muscle strength, increasing fatigue are a few common symptoms most commonly reported and underscored as a side effect by healthcare professional. The onset of symptoms may occur right away from start of the drug or it may happen after 3 to 4 years or even longer and seem to be of gradual onset. The discontinuation of the statin may take weeks or months and at times a year or longer for drug side effect to resolve and it varies.
6. High Index of clinical monitoring for drug side effects/statin drugs. One needs to self-educate about the drugs, its benefits and different side effects that one takes not only for the statin but for any group of drug as a drug side effect is a clinical diagnosis and high index for suspicious drug side effect should be in differential diagnosis for onset of new symptom especially after start of a drug, which may be a few weeks, a few months or even a few years. Learn as much as possible on the drugs so if any drug side effects occurs it can be reported to a healthcare professional. As a patient, one needs to report the drug side effect. If patient don’t report it would be difficult for health care professional to know if there are side effects or not.
7. Healthcare professional may sometimes deny the statin drug side effect. It is possible that healthcare professional may dismiss the drug side effect that one reports, arguing that statins are safe and do not have many side effects and have a lot of benefits. This may not be true completely as self-reporting of drug side effects is far more than in medical research that has been a low report of drug side effects. Ongoing sides effects and further deteriorate the health and cause major organ failure or dysfunction like liver failure, kidney, etc. Deaths have occurred with drug side effects. In many cases, the drug needs to be stopped to see if the presenting presumed drug side effect symptom resolves to some degree or not. If it does, it suggests a drug side effect.
8. Statin drug side effects can be devastating to the health. Statins are high-risk drugs which are used in preventive medicine over the last 10-20 years on a regular basis. A specific V- code is used in medical practice as they are a high-risk drug, for medical coding. Once a person is on more than 3 to 5 drugs, there is a high chance of drug interaction and drug interaction related side effects. This is seen especially in females and older age and there is no specific test to evaluate the statin drug side effect. The blood CK level (blood test) is not helpful in most cases. . At any point, if there is any drug side effect of any group of drug that needs to be discontinued in most cases and the same should be true for statins. For example, if someone is allergic to penicillin then penicillin should be avoided, and the same should be true for statins if there is adequate proof of a drug side effect.
9. On statin means no need for diet: I can eat what I want because I am on a statin. This is a myth that a lot of patients have. The statin drug alone is never superior for diet, exercise and staying active, and weight loss. In a selected group of patients, statins help. For most patients, the use of statins is limited or has not been shown to benefit in the long run. Long-term safety data is also missing as patients are on statins for more than a decade; its safety is not proved. It is known to increase cancer, diabetes. Irrespective if someone is on statin drug or not, an equal emphasis on diet, lifestyle modification, weight loss when appropriate, having lots of fruits and vegetables, high-fiber diet, regular bowel movements and regular exercise still remains a key for overall health.
10. Everyone will need a statin for prevention of heart disease. This is a myth. There are very few absolute indications where a statin has shown a significant improvement and is generally a secondary prevention and not the primary prevention of heart disease. Most studies done are done by drug companies and independent data proving benifit is lacking. It is generally the middle-aged man with a history of coronary artery disease or stent placement who benefits from statin the most. Even the elderly females and persons with no prior heart disease have shown not to benefit from statins and have more side effects than benefits and overall, the risk of statins outweighs the benefits. Children should absolutely not be on statins as the growth of the brain has not occurred, which takes until age 25 for it to complete the physiological process and statins in fact may do more harm than good. Cholesterol is needed for normal functioning of the brain and central nervous system.
If someone is on statins, they should not just stop it. If they are experiencing any drug side effect, they need to talk to a healthcare professional. If you feel that a healthcare professional persists in taking a drug in spite of you having a side effect, you can always have a second opinion. As cholesterol involves every cell molecule in the body, so are the side effects. If someone is experiencing side effects, reporting to the FDA may help for post marketing data and statistical analysis to increase the safety of the drug.
I hope this article may give you a different perspective, which we have seen in our clinical practice. We have seen more drug side effects in clinical practice than real benefit. Real benefit is seen in a few, selected group of patients that we have noted and have seen more secondary prevention than the primary prevention of heart disease with statins. If you feel that this article has helped you, you may consider passing it to your friends and families and maybe to your healthcare professional. Drug safety should be the key in medical management. If one is aware about the statin drug side effects it helps in minimizing drug side effects it should be minimized as much as possible. This applies to any drug side effect and same for statin group also. Best wishes!