Bone Drugs by Merck, Roche, Novartis May Add Leg Fractures
Drugs made by Merck & Co., Roche Holding AG and Novartis AG designed to prevent bone breaks in older women may actually increase the risk of a rare form of leg fractures, a study found.
Women ages 68 and older who took the medicines, called bisphosphonates, for five years or more were 2.7 times more likely to be hospitalized for fractures in part of the thigh bone, according to the study, published today in the Journal of the American Medical Association. The bone breaks, known as atypical femur fractures, are rare and the risk is outweighed by the benefits of the drugs for most patients, researchers said.
The U.S. Food and Drug Administration in October changed the warnings on the drug labels for bisphosphonates and notified patients and doctors of an increased risk of the rare bone breaks. The agency continues to study the breaks, which account for less than one percent of hip and femur fractures overall, according to the FDA’s website.
“Our findings provide strong evidence that prolonged bisphosphonate therapy is associated with an increased risk,” wrote the authors, led by Laura Park-Wyllie, a researcher at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital in Toronto. “Importantly, the results of our study should not deter clinicians and patients from using bisphosphonates in appropriate patients.”
The risk of atypical fractures wasn’t significantly greater for women who took the drug for less than five years, according to the researchers. Patients and doctors may want to consider a “drug holiday” in certain patients who need to take the drug for longer durations, the researchers said.
Bisphosphonate Sales
Merck’s Fosamax was the first bisphosphonate marketed to treat and prevent osteoporosis in older women. The drug reached sales of $3.19 billion in 2005 before facing competition from cheaper generic copies. The drug had sales of $926 million last year, according to data compiled by Bloomberg. Merck is based in Whitehouse Station, New Jersey.
Roche’s Boniva had 2010 revenue of $975 million, and Novartis’s Reclast and Aclasta had sales of $579 million. Roche and Novartis are in Basel, Switzerland.
Three previous studies were unable to prove a link between bisphosphonates and the atypical fractures. Those studies were smaller and focused mostly on women who took the drug for fewer than five years, the researchers said.
Today’s research, funded by the Ontario Ministry of Health, examined records of 205,466 women over the age of 68 who were treated with bisphosphonates between 2002 and 2008. Scientists identified 716 women who had the atypical fractures.
To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
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