As far as I know my mother was not prescribed statins during the last – highly drugged and controlled – years of her life. She was over prescribed unnecessary psychiatric drugs. None of the prescribed drugs were relevant to her closed head injury. She was never referred to a neurologist in spite of my many requests, and she never received speech therapy for the expressive aphasia that kept her even more imprisoned. My brother, a salesman for MetLife, ignored my requests for proper care and later claimed I refused to collaborate on my mother’s care.
Bentley Care Center threatened my brother if my mother was taken off the half dozen+ drugs, telling him she would be forced to move. And most likely Medicare picked up the high priced tab for these drugs, a fraud in itself.
Elders aren’t the only people who are over prescribed drugs by people who are not paying attention to the risks and hazards over time. Health Forensics helps prevent this.
Why Funding Research and Drug Safety is Paramount
By Laura Newman | Jun 30, 2011
My frail, 92-year-old mother was prescribed 80 mgs of the cholesterol-lowering drug, or statin, simvastatin for years. She fell four times in the last four years of her life: the last fall was the least forgiving. Doctors diagnosed her with rhabdomyolysis, a life-threatening condition, and acute kidney failure; she was dead within 8 weeks.
The MedlinePlus encyclopedia defines rhabdomyolysis as “the breakdown of muscle fibers and release of their contents (myoglobin) into the bloodstream.” In severe case, “the myoglobin breaks down into potentially harmful compounds, blocking the kidneys, causing damage such as acute tubular necrosis or kidney failure. Dead muscle tissue may be caused by any condition that results in damage to skeletal muscle, especially trauma.”
The FDA Safety Alert states that symptoms to watch for are: “muscle pain, tenderness or weakness, dark or red-colored urine, and unexplained fatigue” and should be brought to the attention of a health professional. Further, it advises doctors to inform patients taking that dose that they are at risk for rhabdomyolysis.
Rhabdomyolysis is a medical emergency. It is not uncommon after crush injuries, falls, and athletic feats. FDA’s safety warning that 80 mg simvastatin is linked to myopathy, issued on June 8, 2011, struck a chord in me because the 80 mg dose of simvastatin was the same given my mother.
An article in the Nov. 13, 2010 Lancet sounded an alarm that high-dose simvastatin could be hazardous. In a blinded randomized trial of more than 12,000 survivors of acute myocardial infarction, investigators found two (0.03%) cases of myopathy in patients taking 20 mg simvastatin daily, compared with 53 (0.9%) cases in the 80 mg group.
This finding could not be ignored. FDA pressed forward in further analyses. Even as my mother was in crisis, doctors told me that they were astounded that such a high-dose statin was given to a low-risk, frail, elderly women. By low-risk, she had no history of cardiovascular disease and she met the widely used and time-testedFramingham Risk Factor criteria. She did not smoke, had low-level, well-controlled hypertension, but a high cholesterol. I sensed deterioration months before she was diagnosed with rhabdomyolysis. Before she developed life-threatening rhabdomyolysis, she walked everywhere.
The Author and her mother in Canadian Rockies celebrating her 90th birthday. Source: Laura Newman
She called me, saying: “All of a sudden I feel exhausted, like my legs won’t support me, and I keep stopping and sitting down. I just don’t think I can do it anymore.” Who knew whether it was normal aging? Her doctor did not think much of these changes.
FDA’s Simvastatin 80 mg Warning
FDA’s Drug Safety Communication: New Restrictions, Contraindications, and Dose Limitations for Simvastatin to reduce the risk of muscle injury state:
- Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drugs.
- Patients taking simvastatin 80 mg have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class.
- Muscle problems typically occur in the first year of use.
FDA is taking a major step to improve the public’s health. Whether it is far enough is debatable.
The consumer health advocacy group, Public Citizen considers 80 mg simvastatin unsafe and wants it off the market to protect the public. On its Worst Pills, Best Pillswebsite (subscribers only), it presses for a recall of 80 mg dose and urges consumers, no matter how long they have been on it, to ask their doctor for an alternative that is weaker.
According to FDA’s Safety Communication, approximately 2.1 million patients in the US were prescribed a product containing 80 mg simvastatin in 2010.
Prescribing Simvastin in the Elderly
Rodney Hayward, professor of public health and internal medicine at the University of Michigan, told me that sometimes, fatigue and muscle weakness are attributed to aging, when the culprit might be excess dosing. He said: “Unfortunately, people don’t realize that an excessive dose might be causing loss of appetite, muscle problems, and not eating enough. The most common adverse event with the high-dose statins are the myopathies, pain in the muscles.” And if the old are not doing well, the sensible thing is to taper down.”
Also, of critical importance, “as people age, the risks and benefits of people being on medicine change,” said Hayward. “Processing through the kidneys especially is increasingly less effective. You want to be aware of how many medications, and how many doses people are on, and reconcile that with the amount of benefit and risk.”
