Date approved: 1997
Status: Prescription only
Approved uses: Treatment of Paget’s disease
Off-Label uses: Treatment of bone cancer, osteoporosis in post-menopausal women
possible link to osteonecrosis of the jaw (ONJ)
Skelid is a common bisphosphonate drug manufactured by Sanofi Winthrop. It is commonly prescribed to treat and prevent post-menopausal osteoporosis, Paget’s disease, bone cancer and other bone-weakening diseases. Common side effects include rash, bone pain, hives, difficulty breathing, gastrointestinal symptoms and swelling of face, lips, tongues or throat. Bisphosphonates such as Skelid have recently been linked to Osteonecrosis of the Jaw (ONJ). ONJ causes the jawbone to degenerate, resulting in serious and irreparable side effects including bone loss, pain, numbness and exposed bone.
American Association of Endodontists Links Skelid to Osteonecrosis of the Jaw (ONJ)
More than 30 million patients per year take bisphosphonates such as Skelid for the treatment of post-menopausal osteoporosis, bone cancer and Paget’s disease. But a recent report by the American Association of Endodontists has joined a rising tide of sentiment against Skelid and other bisphosphonates, which have been linked to osteonecrosis of the jaw (ONJ), a rare degenerative condition in which the jaw bone dies within the mouth.
What is Skelid?
Skelid (tiludronate) is manufactured by SanofiAventis and is used in the treatment of Paget’s disease and osteoporosis. It is available in 200 mg tablet form. Skelid works by affecting the metabolism of a patient’s bone, presenting the body’s natural resorption of bone tissue and increasing bone mass in patients with bone disease or the risk of bone loss. This is thought to prevent fractures and other bone events; however, Skelid and other bisphosphonates have not been proven to actually create new bone, merely prevent the loss of bone.
Skelid can damage the stomach and esophagus if the pill is caught in the throat, so patients are encouraged to ingest the drug while standing or sitting in an upright position. Juice, soda and mineral water can decrease Skelid’s efficacy, as can food; patients are instructed to take the pill two hours before ingesting any food or any other medication. It is not known whether Skelid affects pregnant women or their unborn children or whether it is safe to breastfeed while taking Skelid. Common Skelid side effects include gastrointestinal symptoms such as nausea and diarrhea; patients may also experience symptoms such as dizziness, headache or generalized body pain, though these may be associated with the symptoms of Paget’s disease and its other treatments.
Bisphosphonates Linked to ONJ
Skelid and other bisphosphonate drugs have been linked in recent years to ONJ, a condition in which the bone fails to recover from minor trauma such as oral surgery and dies within the mouth. Bone death is irreversible; though treatment through long-term antibiotic use and possibly surgery is possible, the lost bone can never be regenerated and patients are at risk for infections in the affected area. Though ONJ has been found primarily in patients who take bisphosphonates intravenously, it has also been recorded in patients who take oral bisphosphonates such as Skelid. Dental and oral surgery procedures are thought to be the primary cause of ONJ, but ONJ has also been found in patients who did not undergo oral surgery. Symptoms of ONJ include a feeling of heaviness or pain within the jaw, loose teeth, and slow gum recovery.
The American Association of Endodontists recently released a position paper identifying bisphosphonate patients as at risk for ONJ and encouraged its members to inquire about their patients’ medical and medication histories before performing oral surgery. Many studies have corroborated bisphosphonates’ association with ONJ, and the FDA has issued warnings to dentists and health care professionals about ONJ risks in addition to requiring more stringent labeling of bisphosphonate drugs such as Skelid.
Have You Been Affected?
If you have experienced ONJ or the other Skelid side effects listed above, get proper medical care immediately. Then contact an attorney with experience in bisphosphonate litigation or Skelid lawsuits. Your Skelid lawyer can help assess your potential claim and tell you whether you might qualify for monetary compensation for your Skelid side effects, including monies for pain and suffering, lost wages, medical bills and hospital stays, and future medical care. Your Skelid 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 Skelid and other oral and intravenous bisphosphonate drugs.