On October 1, 2007, the United States Food and Drug Administration (FDA) released its conclusion from an initial review of bisphosphonate drugs. Despite a New England Journal of Medicine article published on May 3, 2007 that raised safety concerns about the drugs, the FDA said doctors and patients should continue their use of the drugs.

The May 2007 article questioned the association of atrial fibrillation, a heart rhythm disorder, with bisphosphonate drugs, which are used primarily to increase bone mass and reduce risks of fracture in osteoporosis patients.

Bisphosphonate drugs include:

• Fosamax
• Fosamax Plus D
• Reclast
• Didronel
• Boniva
• Aredia
• Actonel
• Skelid
• Zometa

The FDA reviewed reports of this association, but did not identify a class of patients who are at an increased risk of developing the heart rhythm disorder. The agency found most cases of atrial fibrillation occurred more than one month after the administration of the drug.

The FDA said it is unclear how to interpret the data on serious atrial fibrillation associated with the drugs. The FDA added it does not believe doctors or patients should change prescribing practices or the use of bisphosphonates. The agency is, however, seeking additional data to perform an in-depth evaluation of the safety issue for the entire class of bisphosphonates.

Source: “Early communication of ongoing safety review,” United States Food and Drug Administration Press Release, October 1, 2007.

Dr. Gregory Lutcavage, an oral and facial reconstructive surgeon in Goldsboro, NC, is concerned about Fosamax the drug prescribed to many women after menopause to prevent osteoporosis. Dr. Lutcavage is concerned because several years after they’ve taken the drug, Goldsboro patients may wind up in his office with disfiguring and painful ailments that he may not be able to do anything about: jawbone fractures, and osteonecrosis of the jaw.

Osteonecrosis of the jaw is a devastating condition in which the soft tissue inside a person’s jaw dies. Symptoms include jutting and exposed bone, spontaneous jaw fractures, raw and seeping infections, facial collapse and disfigurement. The condition was once known as “fossy jaw” or “phossy jaw” because it developed in workers who were exposed to phosphorus in match-making plants.

A connection has been made between drugs containing bisphosphonates and osteonecrosis of the jaw. Bisphosphonates include Fosamax as well as the intravenous drugs Aredia and Zometa, used in the treatment of cancer. Dr. Lutcavage said that, historically, patients on bisphosphonates may not show the effects of exposure until years of accumulation. The average mean time for patients on the intravenous medications Aredia and Zometa is about a year, but most patients on Fosamax take the drug for as long as three years before the negative effects are seen. In Dr. Lutcavage’s practice, he has seen 24 cases of fractures and osteonecrosis related to bisphosphonate drugs.

Unfortunately for patients, there are no completely effective treatment options. “We’re looking at a loss of jaw,” Dr. Lutcavage said. The treatment options are solely symptomatic. A loss of jaw can be reconstructed with a titanium plate, but once jawbone tissue begins to die, there is no way to halt the process. A person’s jaw, once affected with osteonecrosis, begins to completely break down. Dr. Lutcavage says even titanium plates might not last over the long term because of the deterioration of the bone. Over time, plates and screws may loosen. The only thing a surgeon can do for patients is to “try and get them comfortable again,” Dr. Lutcavage said. “It’s going to get to the point where people will have to live with exposed bone, because we don’t have the treatment.”

Since 2003, more than 3000 cases of osteonecrosis of the jaw have been reported. Dentists are growing increasingly frustrated with the response of drug makers to this issue. “One drug company did not come out with the update to their circular until about three or four months ago,” Dr. Lutcavage said. “We were seeing this three years ago.”

Source: Phyllis Moore, “Doctor warns of drug’s side effects,” Goldsboro News-Argus, July 24, 2006.