Food and Drug Administration to Consider Bisphosphonate "Drug Holidays"

The two advisory panels will consider this Friday whether bisphosphonate drugs are safe and effective in use longer than three to five years.

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.

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 bisphosphonates. Bisphosphonates 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.

Long term use of bisphosphonate drugs has been linked to osteonecrosis if the jaw (ONJ) and hundreds of lawsuits have been filed.

More than 1,000 cases are pending against Merck and Novartis, all involving allegations that the drug makers failed to adequately warn about the risk of osteonecrosis of the jaw (ONJ) associated with their bisphosphonate drugs. A few of the cases have so far gone to court, with mixed results.

In 2009, a Montana jury awarded $3.2 million to a woman who sued Novartis, but in 2010 the company triumphed in a subsequent case.

In 2010, Merck was ordered to pay a 72-year-old plaintiff $8 million in compensatory damages after a jury concluded that the woman's use of Fosamax caused her to develop ONJ and related dental problems. That amount was later reduced to $1.5 million. Another case against Merck was thrown out in 2009, while another jury found in favor of Merck in a case decided in May 2010.

Maybe through this process, a suitable protocol will be developed to treat osteoporosis and protect patients from the harmful side effects of the drugs.