The New York Times Reports: In light of evidence linking the long-term use of Fosamax and femur fractures, the FDA said it plans to convene Friday to determine whether it will recommend suspending the use of the osteoporosis drug. The announcement casts a shadow on the popular Merck product, which is estimated to be used by 4 million American women for the treatment of osteoporosis.
Studies have suggested a link between Fosamax and femur fractures, which may result from Fosamax’s inhibition of bone resorption. The femur, normally one of the strongest bones in the body, may become exceptionally brittle after long-term use of Fosamax.
Because of this risk, the FDA appears to be considering “drug holidays,” which would phase at-risk patients off the drug for periods of time to prevent dangerous prolonged exposure.
Fosamax has been associated with health risks since the FDA required Merck to put warnings about bone-related complications on its packaging 6 years ago. Spontaneous femur fractures, which can occur while performing light-duty activities like walking down stairs, have been a known risk as well. The FDA has required Merck to warn about them since last fall.
Fosamax bone fractures are a primary concern for patients who have been subjected to this sort of continuous, prolonged exposure. The drug has not been proven to be safe when taken for periods longer than 3 to 5 years. Dr. Susan Ott, a bone specialist at the University of Washington, warns that consequences like spontaneous Fosamax bone fractures should not be surprising.
“The longest anybody could have taken this drug is 15 years now. It’s an ongoing experiment, and there are a few million women in the country who are participating in it. I keep wanting to say, ‘You’re all guinea pigs after five years because that’s when the studies stopped.’”
For patients who took Fosamax and femur fractures developed, the FDA’s news holds extra weight. Hundreds of patients have filed claims against Merck stemming from abnormal femur fractures. An official warning or news of a Fosamax recall would bolster the legal outlook of such cases to the tune of millions of dollars.