Quoted from http://www.nytimes.com/2011/09/06/health/06bone.html
F.D.A. to Review Safety of Popular Bone Drugs
By DUFF WILSON
Published: September 5, 2011
Two advisory panels of the Food and Drug Administration will consider on Friday whether to recommend requiring women who use popular bone drugs like Fosamax to take “drug holidays” because of rising concerns about rare side effects with long-term use, according to people involved in the review.
Advisory panels to the F.D.A. are looking at the long-term effects of drugs like Fosamax.
The panels and F.D.A. staff members are also expected to conduct a comprehensive safety review of the medical evidence to date, after 16 years of growing use of the drugs, to determine whether they have proved to be safe and effective in use longer than three to five years. The recommendation could affect many of the estimated four million women in the United States who take the drugs, called biphosphonates. Biphosphonates inhibit a bone renewal process called resorption, adding bone mass, but possibly causing brittleness as well.
Fosamax was first approved in 1995 to treat postmenopausal osteoporosis and Paget’s disease of the bone, conditions that weaken bones. It has also been marketed, controversially, for a pre-osteoporosis condition called osteopenia. The Fosamax patent expired in 2008 and generics have flooded the market.
The F.D.A. announced in July that it would convene a joint meeting of advisory committees on drug safety and reproductive health to reconsider osteoporosis drugs after evidence surfaced linking long-term use with unusual breaks of the femur or thigh bone, bone death in the jaw, and possibly esophageal cancer.
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