Patients who have taken Actonel and have a definitive diagnosis of dead jaw or suffered a thigh or femur fracture while taking the drug.
Actonel reportedly causes osteonecrosis of the jaw, also known as dead jaw, as well as femur fractures in users.
Proctor and Gamble
Actonel treats osteoporosis in postmenopausal women.
The FDA issued an Actonel warning on Sept. 24, 2004.
Manufactured by Proctor and Gamble, Actonel treats osteoporosis in men and postmenopausal women. Actonel was once supplied in daily five milligram doses, but now can be taken as a monthly 150 milligram dose. The drug prevents bone loss by blocking cells that make bones weaker. It also increases bone mass to inhibit bone loss. However, Actonel has been linked to a serious medical condition.
Women taking Actonel may be at risk for developing osteonecrosis of the jaw (ONJ). Osteonecrosis of the jaw occurs when bone tissue in the jaw does not heal after a small trauma, such as tooth removal. This serious medical condition leaves the jaw exposed, which can lead to infection. Osteonecrosis patients may have to undergo lengthy antibiotic treatments and possibly even surgery to treat the infection. Symptoms of osteonecrosis, which is also known as dead jaw, include swelling and infections of the gums, loose teeth, heaviness or numbness in the jaw and exposed bone.
Women using this drug may also be at risk for femur fractures. Reportedly, Actonel and other bisphosphonates may carry an increased risk for femur fractures.