Generic: Risedronate Sodium
Manufacturer: Proctor & Gamble
Date approved: 1998
Status: Prescription only
Approved uses: Treatment of postmenopausal osteoporosis
Off-Label uses: Anti-fracture uses; however, the anti-fracture properties of bisphosphonates such as Actonel, have not been proven
• Osteonecrosis of the Jaw (ONJ)
• bone pain
• tissue death
• loose teeth
• sore gums
• bone loss
• pain and numbness
• difficulty breathing
• bone fractures
• joint disorders
• dental problems
• kidney problems
Actonel is a common bisphosphonate manufactured by Proctor & Gamble and is most often used to treat postmenopausal osteoporosis. It is related to drugs such as Zometa, Aredia and Fosomax. Actonel has been linked to a serious degenerative bone disease known as Osteonecrosis of the Jaw (ONJ). ONJ is often diagnosed when the bone tissue fails to recover from dental work. Side effects of Actonel use that could indicate a more serious problem include bone pain, fractures, joint disorders, and other dental problems.
Actonel Linked With Serious Side Effects
With an increasing elderly population, the pharmaceutical industry is always on the lookout for drugs that will stop the growing wave of decreased bone density and osteoporosis, especially among post-menopausal women. Enter Actonel (risedronate sodium), a bisphosphonate drug manufactured by Proctor & Gamble that claims to increase bone density and help Paget’s disease patients with weakened bones. But Actonel and other bisphosphonates, such as Skelid, Zometa, Boniva and Fosamax, have recently come under fire due to their connection with osteonecrosis of the jaw (ONJ), a rare bone disease in which the jawbone dies.
What is Actonel?
Actonel was approved by the federal Food and Drug Administration (FDA) in 1998 for the treatment of osteoporosis and of cancers that affect the bone. It is recommended that patients do not take Actonel with food, as food inhibits the drug’s effectiveness in the first two and a half hours after ingestion. Though the drug is taken by mouth, it is recommended that patients take it while in an upright position, as extended contact with the esophagus can lead to ulcers.
Actonel works by preventing the resorption of tissue in the bone and regulating bone metabolism, leading to increased bone mass. It should be noted, however, that Actonel does not actually create new bone; it simply prevents additional bone loss. Actonel is not indicated for patients with kidney problems, low calcium levels, or stomach problems. It may irritate the stomach in patients taking non-steroidal anti-inflammatory drugs (NSAIDs) and can interfere with bone-imaging tests.
New Actonel Side Effects
The side effects listed above were known before Actonel went to market in 1998, but the drug has recently been linked to more severe side effects, including ONJ. ONJ is a rare bone condition in which the jaw bone fails to heal after traumatic events. The bone tissue effectively dies within the jaw, requiring extraction of dead tissue and even long-term treatment with antibiotics, which are known to cause a host of additional side effects. Bone death is irreversible, and while the progression of ONJ may be stopped, the damage done by ONJ in patients’ jaws is irreparable. ONJ occurs mainly in patients who have minor trauma to the jaw bone, such as tooth extractions, implants or other oral surgery, but ONJ has been found in patients who did not have oral surgery while taking bisphosphonate drugs such as Actonel. Cancer patients who take bisphosphonates via injection are especially susceptible to ONJ.
Other newly-reported Actonel side effects include severe muscle, joint and bone pain. This pain may be misdiagnosed as osteoporosis-related pain when in fact it is caused by the bisphosphonate drug’s interaction with normal bone metabolism. While the FDA points out that clinical trials conducted before Actonel and other bisphosphonates’ approval did not indicate a risk for severe bone and joint pain, the organization admits that sometimes longer-term effects of the drugs do manifest themselves once the drugs are on the market. The FDA also suggests that severe or extreme bone, joint and muscle pain may be extremely underreported due to doctors’ attributing these symptoms to osteoporosis. This severe pain has been reported in both the risedronate and alendronate (Fosamax) categories of bisphosphonate drugs and may be a class-wide side effect.
Have You Been Affected by Actonel?
If you have experienced ONJ or the other Actonel side effects listed above, get proper medical care immediately. Then contact an attorney with experience in bisphosphonate litigation or Actonel lawsuits. Your Actonel lawyer can help assess your potential claim and tell you whether you might qualify for monetary compensation for your Actonel side effects, including monies for pain and suffering, lost wages, medical bills and hospital stays, and future medical care. Your Actonel attorney will walk you through the process of bisphosphonate litigation, help you file a claim, and assist you in taking steps to get the compensation you deserve for the life-altering side effects of Actonel and other bisphosphonate drugs.