A Utah woman joined the class action suit brought by Linda Secrest, a 60 year old Florida resident, against Merck and Co., makers of the osteoporosis-fighting drug Fosamax. The woman, Pamela Hines, was diagnosed with osteonecrosis of the jaw (ONJ) after a routine tooth extraction. ONJ is a disfiguring and irreversible breakdown of the jawbone and loss of teeth. Ms. Hines’s mouth failed to heal after her extraction. She visited several doctors before learning her ONJ could be linked to the Fosamax she had taken to prevent the loss of bone she now experiences.

Ms. Hines now weighs only 85 pounds and is forced to receive an intravenous antibiotic to help clear her mouth infection. She is unemployed and has to undergo a hyperbaric treatment five days a week. The treatment requires her to lie in an oxygen-rich, pressurized chamber in order to increase the blood and oxygen pumped to her wounds.

Oral surgeons and dentists are becoming increasingly concerned about the number of ONJ cases they are seeing. The concentration of bisphosphonate, the active ingredient in Fosamax that is also in an intravenous drug has been linked to ONJ in cancer patients on chemotherapy, begins to build up in the bones by the third year on the drug. Many women begin to take Fosamax at the onset of menopause and are encouraged by their doctors and aggressive drug marketing to stay on the drug for many years. Bisphosphonates render the jawbone inert, making it impossible for an oral surgeon to perform an implant or for a dentist to drill to remove infection.

Dr. Robert Marx, chair of the oral and maxillofacial surgery department at the University of Miami medical school, believes that Merck and Co. did not anticipate the extent to which bisphosphonates can affect the jaw compared with other bones in the body. Dr. Marx first raised concern three years ago about the effects of Fosamax on the jaw and says Merck did not do enough testing on the jaw in clinical trials. Marx believes that if Merck had done the additional testing, “They could’ve predicted this might occur.”

Approximately 4.2 million prescriptions for Fosamax were written last year; yet despite a 2004 FDA report by the Office of Drug Safety about the risks of jawbone necrosis with Fosamax as well as Actonel and Boniva, two similar osteoporosis drugs, Merck has never released a “Dear Doctor” letter warning of the ONJ risk associated with its product.

Osteonecrosis “can’t be fixed,” says Hillel Ephros, chair of the St. Joseph’s Regional Medical Center in Paterson, NJ. That makes dentists and oral surgeons wary of even accepting patients who take Fosamax because of the risk that the patient will contract ONJ.

Sources: Carey Hamilton, “Fosamax lawsuit brings risks to light,” Salt Lake Tribune, June 20, 2006, accessed June 22, 2006; Ed Silverman, “Bone-building drugs linked to bone-rotting side effect,” New Jersey Star-Ledger, June 13, 2006, accessed June 22, 2006.