Elder Drugs » Pain

FDA Safety Changes in Labeling for Statins: Memory Loss, Diabetes, Muscle Pain

Alan Lukazewski — Wed, 29 Feb 2012 13:30:49 +0000

I’ve posted for some time on the potential for some older adults to experience life-altering adverse effects from statins, such as Crestor (rosuvastatin), Zocor (simvastatin), Lipitor (atorvastatin), etc. One adverse effect that has been of particular interest is that of memory loss, or confusion. When a resident of our retirement community said his statin was causing memory loss, I at first did not believe him. Then he tried another statin and the same reaction happened. This was THE event that opened my eyes to the very issue of adverse drug events in older adults. Now the FDA has issued a news release regarding labeling changes for statins, including the potential for memory loss or confusion. Although this side-effect is established, we must also recognize the benefits of these medications in those at risk for cardiovascular events, such as heart attack or stroke. No one should stop taking their statin until they have an informed discussion with their physician. Here’s the link to the FDA alert and the other Elder Drugs posts on statins.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm293623.htm

http://elderdrugs.com/2011/09/my-statin-causes-memory-loss-now-if-i-could-only-remember-to-tell-my-physician/

http://elderdrugs.com/2011/07/simvastatin-zocor-new-warnings-from-fda/

http://elderdrugs.com/2011/07/statin-use-in-older-adults-benefit-or-unnecessary-risk/

Patient Reported Symptoms from Crestor

Alan Lukazewski — Thu, 19 Jan 2012 13:16:20 +0000

Here’s a link from AskAPatient.com, a consumer-based website that allows people to post what they believe are side-effects from their medications. Although there is no validation that reported side-effects are always from the medication, there is usually a trend that can be followed along with some activity by the person helping to point the finger of suspicion at a particular medication. One way to strengthen an argument that a medication is responsible for a life-altering side-effect is to stop it, and then monitor how you feel and function. This report is on Crestor, not that I’m picking on Crestor, but it speaks well to how the medication is most likely responsible for such severe pain that it prevented this 86 year old women from being able to care for herself. In the final analysis, one would want to consider restarting the Crestor and see if the same side-effect returns. If it does, then we have further strengthened the argument that the drug is responsible. These reports also strengthen the argument that people with changes in how they feel and function, especially after starting a new medication, should report them to their physician and not take no for an answer until there has been a rigorous process to verify if the medication may be responsible. A simple shrug of the shoulders or a “I think not” reply should not suffice.

http://www.askapatient.com/viewrating.asp?drug=21366&name=CRESTOR

Minimizing Drug Misuse Among Elders: a Proposal

Alan Lukazewski — Wed, 23 Nov 2011 04:32:04 +0000

“Something old, something new” is what I thought of when I read this article from 1987, that proposed tracking OTC use among elders in the community in order to study OTC misuse leading to adverse drug events. This is not a new concept, that OTCs can cause harm and should be considered a vital part of the medication review. However, many pharmacies do not, and cannot track OTC use, nor do medication interviews always pick up on OTC use. However, we do know that OTC NSAID use is a large contributor to gastrointestinal bleeding among older adults, and they can be used in those taking other drugs that can put an older adult at risk for hemorrhaging. We can also see hypertension caused by NSAIDs along with renal damage from chronic use. So finding out about OTC use is important.

What we have found in some of our falls prevention workshops, when performing medication reviews, is that older adults tend to not report these OTCs as part of their drug regimen thinking they are safe or not of any consequence. We have learned to probe by asking the specific questions: “Do you use an OTC pain medication like Motrin, (iburpofen), Aleve (naproxen), etc. for pain?” We also ask about OTC medications like Tylenol PM for sleep. OTC sleep medications contain antihistamines that are known to cause memory health issues and also contribute to falls.

So I ask myself, when looking at all the studies on adverse drug events in older adults going back 20 or more years, which cover many of the same topics, and uncover many of the same findings as studies published more recently, is this something old, or something new?

When having your medications reviewed, or if you review medications of others as a practitioner, include all the OTCs and herbal supplements, or where non-drug interventions are beneficial. Here’s the link to the article authored by Jean Craig and Gayle eves:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1477723/pdf/pubhealthrep00179-0088.pdf

Bones and Brains, Pee and Pain: All You Need To Know to Age Well

Alan Lukazewski — Thu, 28 Oct 2010 00:38:27 +0000

The acronym BBPP© stands for Bones and Brains, Pee and Pain ©, four interrelated categories that house the morass of almost twenty geriatric syndromes. It was developed as a model to show how medications can alter the course of geriatric syndromes by affecting one domain, thereby affecting another and hastening the downward spiral of frailty. The BBPP© model also helps us understand how thoughtfully altering medications can do the opposite and lead to improved function and quality of life. The idea that frailty is an elastic process, meaning it is not always a negative trend, is best described by Dr. Rejean Hebert: He describes how one-third of older adults regained their previously lost function in one year thereby showing that decline may reversible.

Explanation
Based on observation, and verification in the literature, it is clear that medications can be the cause of many problems instead of the cure. The literature shows that adverse drug events hasten decline in older adults by precipitating geriatric syndromes, such as falls, memory loss, incontinence, among others. These types of ADEs I call “soft ADEs”, as opposed to the usually reported ADEs of GI bleeding, electrolyte imbalances, hypoglycemia, and others. “Soft-ADEs” are instances where a side-effect of a medication can cause or worsen a geriatric syndrome, which alone can affect another area of function. The development of the drug-induced syndrome can also lead to the prescribing of additional medication for symptom management which can cause another geriatric syndrome, when in fact what is needed is an adjustment of the current medication regimen by withdrawing the drug, altering the dose, or finding a cleaner acting drug. The BBPP© model simplifies the complexity of the interrelationship between geriatric syndromes in relation to medications commonly used in older adults.

Here’s how it works
Falls is a geriatric syndrome and a leading cause for loss of independence in older adults. There are many risk factors in play so one approach is not enough to effectively lower risk. To some degree there is an over-reliance on bone health drugs to prevent fractures when in fact preventing falls is more effective at reducing fracture risk. We also know that taking a medication that causes cognitive impairment can contribute to or cause falls. Examples are Tylenol PM, antihistamines, Valium-like drugs (benzodiazepines), or in rare instances statins. Using statins as an example, they are now validated to be a risk factor for falls due to the muscle weakness and pain that exist as side-effects in some individuals. Statins can also cause memory loss and what may happen is Aricept may be prescribed to someone we think has dementia when it can actually be medication-induced. However, Aricept can cause urinary incontinence thereby increasing fall risk. A drug for incontinence is then often prescribed which antagonizes the beneficial effects of Aricept and can cause further cognitive impairment. Incontinence also leads to social isolation which also is a risk factor for depression. Depression also leads to memory loss issues even in those without dementia. So you can see that medication use can affect several different areas such as Bones (falls), Brains (memory loss, depression), Pee (urinary incontinence) and Pain (muscle pain), and all caused by medications.

This was a brief overview of the BBPP© concept that teaches you to 1) If you have issues with BBPP©, always suspect your medications until proven otherwise, 2) Don’t over-rely on medications to manage your health risk, and 3) Understand that many of our organ systems are interrelated and taking a medication can affect more than one system leading to functional decline or loss of independence. If you are taking more than four medications and have concerns with your ability to function, please consider a comprehensive medication review to rule out medications as the cause of your problems.