Actonel (risedronate) is a prescription medication used in the treatment of osteoporosis for postmenopausal women, Paget’s disease, osteoporosis, and osteoporosis from glucocorticoid treatment. Actonel reduces the incidence of bone fractures from osteoporosis by increasing bone mass. Actonel has an affinity for a material in bones called hydroxyapatite. Actonel is an anti-resorptive agent, meaning that it alters the formation and breakdown cycles of bone tissue. Actonel prevents bones from breaking because it slows down the loss of bone tissue while increasing the amount of bone mass.
The U.S. Food and Drug Administration (FDA) urged caution about long-term usage of Actonel for the treatment of osteoporosis and other bone weakening conditions. Actonel and other similar drugs were linked to rare fractures and other side effects. In some cases, side effects were severe enough to warrant compensation to the patient from the drug manufacturer.
Bone Fractures from Actonel
Reports have emerged that after three to five years of treatment some patients may experience unusual bone fractures. Many times, this has occurred in the femur, or thigh bone, and there was little to no cause for the breakage. In some cases, these injuries occurred in both legs of the patient. These bone fractures were also unusually slow to heal.
Some experts think this is part of the way the medication works. The primary effect from the medication is through slowing down the process of “bone remodeling” which repairs small cracks in the bone structure. Over time, the small breaks become numerous from everyday activity and causes bone structure to become brittle.
Research has indicated that these types of bone fractures are usually rare. However, a study assessing the risk of atypical femur fractures showed an increased rate based on the duration of treatment from Actonel. The rates increased from 2 to 78 out of 100,000 per year between two and six years of treatment using Actonel.
Other Actonel Side Effects
Bone fracture is among the most serious Actonel side effects but there are also other serious conditions that can result from the medication. Osteonecrosis of the Jaw (ONJ) is a painful condition where bone tissue fails to heal after undergoing dental work. For example, a simple procedure like tooth extraction can lead to infections, jaw fracture, and necrosis of adjacent tissues. The tendency for the condition to cause rotting around the jaw is why it is also called “Dead Jaw Syndrome.” The condition has affected up to 10 percent of Actonel patients. Antibiotics and surgery are usually necessary for treating the issue.
Other Actonel side effects:
- Chest pain
- Upset stomach or stomach pain
- Flu symptoms
- Diarrhea or constipation
- Joint, bone, or muscle pain
FDA Review of Actonel
Actonel is a medication from the bisphosphonate class of compounds. Bisphosphonates are all used for the treatment of bone loss for at risk populations. There is a common link between all the bisphosphonate compounds, like Actonel, which is that their efficacy plateaus after three to five years. This is one of the reasons why the FDA recommended a safety review of the drug.
The labels for the bisphosphonates were revised to inform doctors and patients about the decline in efficacy and serious side effects associated with bisphosphonates. The concerns were prompted over a percentage of users who had incurred unusual fractures of the femur and ONJ. While this percentage is relatively small, there is a concern that the drugs may increase the risk of severe side effects when used for an extended duration. The revision is mostly to help curb the incidence of patients being prescribed Actonel as a prevention for bone loss and osteoporosis.