An FDA review of bone building drugs widely used to treat osteoporosis has found that they provide little if any benefit after long term use – and may even lead to more bone fractures. About 10 million Americans suffer from chronic pain caused by osteoporosis and bisphosphonates have long been recommended as a way to treat the disease.
The FDA review, published online in The New England Journal of Medicine, was prompted by growing evidence that long term use of bisphosphonates may actually lead to weaker bones in some women. Osteoporosis is caused by a decline in mineral bone density, which makes bones weaker over time and more likely to fracture. To rebuild bone density, millions of elderly Americans have been prescribed bisphosphonates, which are sold under the brand names Fosamax, Boniva, Actonel, and Reclast, as well as some generic drugs.
The FDA stopped short of recommending that people stop taking the drugs, but said cautionary labeling should be updated. The agency reviewed studies which found that after three to five years of use, bisphosphonates may contribute to thigh fractures, jawbone deterioration or even esophageal cancer.
The review only analyzed long-term use and did not address whether a woman should be prescribed a bone building drug in the first place. Women are more likely than men to get osteoporosis, because after menopause their bones start to lose density faster. A review of two industry funded studies showed significant reductions in fracture risks during the first three to four years, but little or no benefit afterward.
Osteoporosis is responsible for 1.5 million fractures in the U.S. annually at a cost of $14 billion. About half of all women and a quarter of all men over the age of 50 will break a bone due to osteoporosis, according to the National Institutes of Health.
The National Osteoporosis Foundation and the National Bone Health Alliance, both of which are funded by drug makers, issued statements urging patients not to stop taking bisphosphonates without first discussing it with a physician.
“Members of the public and healthcare professionals alike have been looking for clear guidance about appropriate length of time to continue bisphosphonate treatment. I’m happy to see the importance of regularly monitoring patients on an individual basis to determine their need for continued therapy,” said Robert Recker, MD, president of the National Osteoporosis Foundation and vice-chair of the National Bone Health Alliance.
Recker also claimed that “drug holidays” would be a way to avoid long term use of bisphosphonates.
“As suggested by the FDA’s ongoing analysis, giving some patients intermittent drug holidays may be appropriate clinical practice,” said Recker.
Bisphosphonates generate billions of dollars in revenue for drug makers around the world. According to Bloomberg, Actonel generated $771 million in 2011 sales for Warner Chilcott, Boniva generated $788 million for Roche and Fosamax had sales of $855 million for Merck.