Terri Bernacchi, PharmD, MBA, Health Advisory Professionals
As a pharmacist in the 80’s, I did not have a great esteem for the drug Propoxyphene or its various combinations. I believed the drug to be nothing more than a weak narcotic with placebo-like analgesic benefits. The product was long held in disregard by the medical community in my periphery and was believed to be pretty harmless. Old ladies and malingering patients were offered it, every 4 hours, around the clock, to deal with levels of pain that the physician may have believed were benign, self-limiting or minimal. One problem with this attitude on the use of any analgesic drug is that there is a tendency by patients to increase their dosage when their pain becomes more severe. Unfortunately, this could result in addiction and even death, especially with elderly people or folks who like to drink alcohol.
Because the product was a cheap multisource option, it had become one of the most frequently used analgesics, especially the acetaminophen combination product (and the benefit of analgesia was often thought to be due to the acetaminophen component). Propoxyphene containing products are estimated to have had 20 million prescriptions dispensed in 2007 in the US. Propoxyphene was introduced to the US market in 1957, before products approved by the FDA had to establish anything more than safety. The drug was banned by Britain in 2005, by Europe in 2009; that same year an FDA advisory committee recommended the removal of propoxyphene-containing products, but that recommendation was rejected by the agency which believed the product still had an acceptable risk-benefit profile at appropriate doses. The FDA ordered a study of the drug's effects on the heart by the manufacturer of the branded form (Xanodyne).
Recently (on November 19, 2010), in describing its reasons for asking the manufacturers to cease producing the drug, the FDA noted that even when patients took the recommended doses of these drugs, meaningful changes could occur to the electric activity of the heart, potentially resulting in sudden death. Specifically, “These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.” (See the FDA announcement at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm )
It is clear to me as I look backward to those years that the medical, nursing and pharmacy communities may lose perspective on frequently used drugs like propoxyphene. We may forget that what we ask the patient to do vis-à-vis dosing instructions and guidance on how to handle side effects may not actually be what they do when they go home. Instead, they follow predictable patterns of self-care and they may not understand the consequences of their actions when they increase the dose because the pain relief is inadequate. I’m not sure that it amounts to callousness on the part of the medical practitioner so much as the stickiness of the routine and the mundane in our daily efforts.
Although there were people trying to get the drug removed since 1978, it was not until the recently released study that a definitive decision was made. But it does give me a new respect for the potential for any drug----even those that we think are completely safe or even inconsequential----to cause harm.
Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets. The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago. She has both a BS and a PharmD in Pharmacy and an MBA.
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