An Oregon woman has been diagnosed with Bisphosphonate-associated osteonecrosis of the jaw (BONJ) following intravenous administration of Reclast ®. Osteonecrosis of the jaw is also called "dead jaw disease." BONJ is a terrible and painful disease in which the jawbone dies and the teeth must be pulled. Many people have already sued drug companies for BONJ. To date, only one jury has ruled, and it found that Novartis owed the woman $3.2 million.
As women age, their bone density decreases. Bisphosphonates are a class of drugs sold to increase bone density. Women are told that their risk of bone fractures will decrease if they take the drugs. Doctors also prescribe bisphosphonates for cancer treatment and other conditions. Unfortunately, too often, women are not told about the risk of osteonecrosis of the jaw or who might be more susceptible to getting it.
One type of bisphosphonate is Zoledronic Acid, manufactured by Novartis and sold under the names of Zometa ® and Reclast ®. Many people have sued Novartis alleging that Zometa ® caused their jaw to die and that Novartis should have either better understood the risks of their drug or better communicated the risks to doctors and patients.
Novartis first sold Zoledronic Acid for cancer patients under the name Zometa ®. So, the first associations between the drug and osteonecrosis involved cancer patients. (Migliorati CA, Lancet Oncol. 2006 Jun;7(6):508-14). Later, Novartis sold it under the name of Reclast ® for helping to boost bone density.
Zoledronic Acid is the most potent of bisphosphonates. Intravenous administration (IV) -- compared to taking a pill -- increases the amount of the drug available to the body and increases the risk for osteonecrosis of the jaw. Prior use of bisphosphonates likely increases the risk of dead jaw disease when a woman later has the IV. In the case of the Oregon woman, she had taken Fosamax ® for a short time many years before receiving Reclast ® intravenously.
Jeff Merrick, Oregon Trial Attorney
503-665-4234
