Pain Killers, Falls and Fractures: The Unintended Consequences of the Vioxx Recall

Newswise — CHICAGO – Falls and fractures among senior citizens have increased since rofecoxib (Vioxx®) was removed from the market in 2004, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Chicago.

Narcotic analgesics (more commonly called narcotic pain killers), such as morphine and oxycodone, have long been used to treat pain. However, alternatives to this method of pain management have been identified, including the use of Cox-2 inhibitors, such as celecoxib (Celebrex®) and the now-recalled rofecoxib, which was removed from the market after being shown to increase the risk of heart attacks and strokes. With the recall of rofecoxib, many patients turned to the use of narcotic pain killers to manage pain from diseases like osteoarthritis (the most common joint disease affecting middle-age and older people. It is characterized by progressive damage to the joint cartilage—the cushioning material at the end of long bones—and causes changes in the structures around the joint).

Researchers recently studied whether the increase of narcotic pain killer use among senior citizens also meant an increase in falls and fractures. They pulled the medical records of over 10,000 people — who were over the age of 65 and had been diagnosed with osteoarthritis —and reviewed their records from 2001 through 2009. They noted if and when a patient had a fall or fracture as well as whether each patient fell into one of three categories of pain management: use of narcotic analgesics with the use of other, non-narcotic analgesics (such as nonsteroidal anti-inflammatory drugs); use of Cox-2 inhibitors alone or with other non-narcotic analgesics; and use of NSAIDs, other or no use of pain medication.

First, the researchers looked at the use of narcotic pain killers. Between 2001 and 2004, use jumped from eight percent to 20 percent, and it doubled to 40 percent by 2009. The use of Cox-2 inhibitors was low among these patients throughout the entire study period (eight percent). Next the researchers looked at falls and fractures and noted that less than one percent of these patients had a fall or fracture in 2001 but this increased four-fold (to 4%) by 2009, and this increase in falls and fractures was strongly associated with the increased use of narcotic pain killers.

“Overall there was a marked increase in the percentage of elderly patients who suffered a fall or fracture, and this increase paralleled the increased percentage of patients given narcotic pain relievers over this time period,” explains Bruce N. Cronstein, MD; senior investigator in the study and Paul R. Esserman Professor of Medicine; director, NYU-HHC Clinical and Translational Science Institute; associate director for research, Department of Medicine; director, Division of Translational Medicine, New York University School of Medicine.

The research team also noted that, those who fell (regardless of what type of pain management they received) were older (in their 70s and 80s) and tended to be sicker than the individuals who did not suffer a fall or fracture. These findings made the researchers take a closer look at the effect of age and co-existing diseases and conditions on the risk for falls or fractures by comparing patients who fell to those who did not but who had similar health status and age.

“It is well known that as the elderly develop more chronic illnesses they become more frail and are more likely to fall and break a bone. We wanted to determine whether the risk of falls was associated with the use of narcotic pain relievers or whether physicians simply used narcotic pain relievers in older and sicker patients with chronic osteoarthritis,” says Dr. Cronstein.

Patients who were taking narcotic pain killers were around four times more likely to suffer a fall than patients taking other types of pain relief for their OA – regardless of their health status or age. Ultimately, the study showed that falls and fractures increased among these patients when rofecoxib was removed from the market and narcotic pain killers were used in its place. These observations, lead researchers to believe that the recommendation for chronic pain treatment should be evaluated.

“The medical community only recently found that both COX2-selective and non-selective NSAIDS, including those available over the counter (e.g. ibuprofen), can increase the risk for heart attacks and other types of cardiovascular disease. Because of this discovery, some of these drugs — rofecoxib and valdecoxib — were taken off the market in late 2004 and 2005. Thereafter, there were marked changes in prescribing patterns for pain relievers to treat chronic diseases. We found that prescribing narcotic pain relievers before or instead of other types of pain relievers, as recommended in a number of practice guidelines from several professional groups, has the unintended consequence of increasing the risk for falling and fractures in the elderly. These results should lead to a reconsideration of these guidelines,” concludes Dr. Cronstein.

The American College of Rheumatology is an international professional medical society that represents more than 8,000 rheumatologists and rheumatology health professionals around the world. Its mission is to advance rheumatology. The ACR/ARHP Annual Scientific Meeting is the premier meeting in rheumatology. For more information about the meeting, visit www.rheumatology.org/education. Follow the meeting on Twitter by using the official hashtag: #ACR2011.

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Editor’s Notes: Lydia Rolita, MD will present this research during the ACR Annual Scientific Meeting at McCormick Place Convention Center from 9:00 – 11:00 AM on Monday, November 7 in Hall F2. Dr. Rolita will be available for media questions and briefing at 8:30 AM on Monday, November 7 in the on-site press conference room, W 175C.

Learn more about living well with rheumatic disease as well as rheumatologists and the role they play in health care. Also, discover the ACR’s Simple Tasks campaign, which highlights how rheumatic diseases strike women disproportionately and in the prime of their lives.

Presentation Number: 911

Unintended Consequences; Increased Prescription of Narcotic Analgesics for OA in the Elderly Is Associated with Increased Falls and Fractures in the Post-Vioxx Era

Lydia Rolita (NYU School of Medicine, New York, NY)Adele Spegman (Geisinger Health System, Danville, PA) Bruce N. Cronstein (New York Univ Medical Center, New York, NY)

Background/Purpose: Narcotic analgesics (NA) have long been used to treat pain although a number of alternatives have been developed, including selective COX-2 inhibitors. In 2004 Merck withdrew Rofecoxib from the market due to cardiovascular events and subsequent guidelines for treating chronic pain by the AHA and AGS recommend short-term narcotic analgesic use as the first step in managing chronic pain. Falls in the elderly are common and because NA contribute to falls in the elderly we determined whether prescriptions for NA for elderly patients were increased after COX-2 inhibitors were taken off the market and whether the incidence of falls/fractures changed in these patients.

Methods: Records of all patients >65yo with a diagnosis of OA (>10,000 patients) over the years 2001-2009 were identified in the Geisinger EMR data warehouse for analysis. Diagnoses of falls and fractures were identified by ICD 9 codes. Three analgesic prescription groups were identified: NA with or without other analgesics, COX-2 alone or with other analgesics, and NSAIDS, others and none. Other factors analyzed were age, gender, and Charlson Index Score of comorbidities (CI).

Results: From 2001-2004, patients receiving only NA prescriptions increased from 8% to 20% of the population and doubled again to 40% by 2009. COX-2 usage was low in this population (8%). The incidence of falls/fractures increased from less than 1% of all patients in 2001 to 4% in 2009 (Fig 2) and appears to be associated with the increased use of narcotic analgesics (Figure 2). Across all groups, patients with falls were older (78.1±6.6 v 73.8±6.3), yet in the NA group only, patients with falls had higher CI. The influence of age and comorbidities on falls were examined using conditional logistic regression; no fall patients were matched 3:1 to fall patients according to age and CI at time of fall. Falls risk increased with NA use in both study periods. In 2005-2009 when compared with: COX-2, NA use was associated with a 3.7 OR (2.6, 5.4; p < .001) and with NSAID a 4.4 OR for falls (3.9, 4.9; p < .001).

Conclusion: After Vioxx was taken off the market there was a marked increase in the prescription of narcotic analgesics. Falls and fractures in this elderly population with OA increased markedly and all of the increase in falls were in patients prescribed narcotic analgesics. These findings strongly indicate that recommendations for the treatment of chronic pain be re-evaluated.

Disclosure: L. Rolita, None; A. Spegman, None; B. N. Cronstein, Eli Lilly & Co.; UCB ;Pfizer; Vilcek Foundation; Probably others I don’t remember , 6, Patent, Canfite Pharma; Bristol-Myers Squibb; Tap Pharmaceuticals; Prometheus laboratories; Regeneration (Westat, DSMB); Endocyte; Savient. , 5, Canfite Piophamaceuticals, 1, NIH; Vilcek Foundation; URL Pharma, 2.