Actonel (risedronate sodium) is a bisphosphonate drug used to treat osteoporosis in men and postmenopausal women. In different dosage regimens, it is also used to manage the metastasis of advanced cancer to the bone, and for Paget’s disease, a condition involving the abnormal growth of unhealthy bone cells.
Actonel and Women
For postmenopausal women diagnosed with osteoporosis, Actonel is widely prescribed to reduce the incidence of vertebral fractures and other osteoporosis-related fractures. For men suffering from osteoporosis, Actonel is used to increase bone mass. Taken orally in tablet form, it acts to inhibit the growth of unhealthy osteoclasts, or bone cells. Used intravenously in higher strengths for cancer treatment, it aids in the management of bone malignancy. Across the spectrum of use, serious side effects have been reported.
The most serious of these side effects is Osteonecrosis of the Jaw (ONJ), affecting individuals who undergo dental treatment while on a regimen of Actonel. Also referred to as Dead Jaw Syndrome, ONJ affects up to 10% of people on Actonel and related bisphosphonate drugs and is diagnosed when bone tissue fails to heal after tooth extraction. The bone is exposed, which leads to infection and jaw fractures, which can require treatment ranging from antibiotic therapy to surgery to remove the necrotized bone. Concerns reported about the incidence of ONJ among patients taking Actonel prompted the FDA to issue a warning to health care professionals, with recommendations to ask about bisphosphonate use before dental procedures such as extractions.
Actonel and Femur Fractures
Actonel use has also been implicated in the incidence of atypical subtrochanteric femur fractures, a painful kind of fracture occurring just below the hip. Although the FDA took this concern under review in 2008, it stated that a review of the data did not show an increase in these fractures among Actonel users.
Additional Side Effects
ONJ and increased risk of femur fracture are only two of the serious side effects of Actonel. Adverse effects on the gastrointestinal system are common, including abdominal pain, diarrhea, dyspepsia, and gastritis. In addition, disorders of the upper gastrointestinal system and esophagus, such as esophagitis, dysphagia, and esophageal and gastric ulcers, have also been linked to Actonel use. Musculoskeletal problems such as back pain, arthralgia, myalgia and bone pain are associated with Actonel as well.
When compared with a regimen of calcium supplements with Vitamin D, Actonel therapy initially resulted in a greater improvement in bone mass. However, with prolonged use this trend was reversed, revealing a higher correlation between Actonel use and compromised bone health.
Lawsuits involving Actonel users who have suffered serious side effects have been filed throughout the United States. Prompted by increasing concerns, the FDA has issued warnings about some adverse effects associated with Actonel, but others remain under review.