The Safety of Taking Prolia (and any Other Medications)
Question: Do you have any information on the side effects of Prolia when a person has PPS? My doctors want me to take it since I already have had a spontaneous back fracture without a fall. They keep warning that I will have more fractures because of my severe osteoporosis. Cheerful advice! Frankly I am reluctant to try it, because one of the side effects is muscle pain. I have enough of that already! Any advice would be greatly appreciated.
Dr. DeMayo’s Reply: Wonderful question!
The specific answer in your case is one that must be decided between you and your primary care physician or bone specialist. It is important to know that I am neither a primary care physician nor a bone specialist. However, I do have some comments that may be useful in your decision-making process. My first comment would be - avoid letting fear enter into the decision-making process because the decisionmaking process should be about deciding which option would lead to the best outcome or which option has the least chance of a bad outcome (in other words, which should be feared less). When someone is fearful of one of the options to start, they in fact have already made a decision. Fear has a tendency to paralyze and sometimes the “do nothing” option is really the one that should be the biggest concern. Perhaps I can illustrate with an example from a patient encounter I had last year. I was evaluating I women who had problems with fibromyalgia, diabetic nerve pain, and depression, she came to me after failing treatment with several other physicians. Cymbalta is a medication approved for all three of these conditions and therefore a logical option to consider as part of her overall plan. Our exchange went something like this:
Dr. DeMayo: “Cymbalta is a medication that can help with fibromyalgia, diabetic nerve pain, and depressionhas it been tried in the past?”
Patient: “I won’t take it.”
Dr. DeMayo: “Did you have problems with it” Patient: “I won’t try it. I saw the commercial”
Dr. DeMayo: “What was it in the commercial that concerns you?”
Patient: “I don’t remember it just scared me.”
The question here is not whether or not Cymbalta is a “good” drug or not, the issue is that a conversation could not occur because fear stood in the way.
In determining whether or not a specific medication is a good option for an individual, it always makes sense to review risks and benefits. The Internet has made lots of information readily available to individuals. That information can be helpful or confuse the decision making process. I always recommend going to well established peer reviewed websites. The goal should be to gather general information and reserve specific decision making until you can review that information with your physician. No matter how reliable the source, the context of the information may be very different for an individual case. As an example, for medications, I often use Epocrates.com to start. Indeed, for Prolia, extremity pain/back pain/arthralgias are listed near the top of the “common” adverse reaction list. As such, it would be very important to look at these as potential problems for a patient with post-polio. Nevertheless, digging deeper into the issue, one finds that the studies reporting these adverse reactions showed a very high incidence of the same adverse reactions when individuals were given a placebo (sugar pill). For Prolia the data shows the following:
It doesn’t take long to see that the “common adverse effects” are minimally above the frequency seen in the tested population to begin with. As such, the increase in risk appears much smaller. It should also be noted that hypocalcemia is relatively uncommon compared to other problems, but occurs more than four times as often when taking Prolia. This is mostly a concern for individuals with hyperparathyroidism, thyroid surgery, malabsorption problems, or severe kidney disease. Nevertheless, for them, hypocalcemia may be a very important issue since it can be life-threatening if not recognized. It is also important to look beyond statistics and look at how a medication actually affects the individual. With non-life-threatening and temporary side effects, it is often advisable to try the medication for a defined amount of time, stop it, and then restart it. This is done while keeping a log of the symptoms. When this process is “negotiated” upfront with the physician and actual individual response is evaluated together it can lead to a collaborative relationship that produces optimal outcome. I suggest a research validated symptom scale* be used for the log when possible and this can be discussed with the physician.
On the benefits side of the risk/benefit formula, the benefits of Prolia include a significant 68% reduction in new vertebral fractures in postmenopausal women. This number is even more impressive given the fact that fractures can lead to significant disability, nursing home stays and even death. Given the information you provided regarding a spontaneous vertebral fracture in the past, you would fall into a high risk group for further fractures and optimal risk reduction is certainly reasonable to discuss. As with any good cost/risk versus benefit analysis, it is always helpful to make decisions along with professionals who know your individual situation. In this case your primary care physician or bone specialist.
Don't be afraid to talk to your doctor about questions or concerns you have with medications they are prescribing.
*A validated scale is one that has been shown in research to be accurate, sensitive, specific, and reproducible.
Graphic: drvee.wordpress.com