The Dental Hub has previously published two articles on bisphosphonate drugs which are primarily taken by women to prevent osteoporosis (see:

• New Study on Osteonecrosis of the Jaw (ONJ)
• Zoledronic Acid May Reduce Bone Loss Associated With Osteolytic Squamous Cell Carcinoma (OSCC).

Now the U.S. Food and Drug Administration has convened two advisory panels to consider clarification of the length of time these drugs should be used.  The drugs under consideration include Merck & Co's Fosamax, Warner Chilcott's Actonel, Novartis' Reclast, and Roche's Boniva.

According to a September 9th, 2011 article by Reuters (author Alina Selyukh), "no advantage exists in staying on the drug beyond five years, FDA researchers have said".

Since 2005, bisphosphonates drugs have contained a caution about the possible risk of osteonecrosis of the jaws, a condition that has been reported in the dental and medical literature.  In 2009 there was additional caution re GI reactions and in 2011 a warning was also placed regarding atypical femur fractures and kidney failure. A recent lawsuit against Merck has been allowed to proceed on the basis that their product Fosamax has a design defect which can cause the jawbone tissue to undergo necroses.  While the mechanisms related to the development of jaw osteonecrosis remain unclear, the above government actions suggest that dentists need to continue to monitor their patients for the use of bisphosphonate drugs and consider their use in treatment planning.
Dr Jeff Burgess Editor in Chief

"Despite rare side effects, those patients who take bisphosphonates have fewer fractures and lower mortality, and these findings need to be shared with our patients," he said.

Makers of the drugs emphasized that studies have not directly linked or explained the connection between their medicines and adverse side effects. They voiced concerns about the lack of data on what happens to patients who go off treatment and suggested "drug holiday" decisions are best done for each patient individually.

"A drug holiday may be appropriate for some patients, but that decision should be based on an individual risk-benefit basis, and a physician is in the best position to make that decision overall," said Joseph Kohles, international medical leader for Boniva at Roche.
By Alina Selyukh