Generic: Pamidronate Diodium
Date approved: 1991
Status: Prescription Only
Approved uses: Treatment of hypocalcaemia, Paget’s Disease, and cancer
Off-Label uses: Anti-fracture uses; however, the anti-fracture properties of bisphosphonates such as Aredia, 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
Related topics: Fosamax, Actonel, Boniva, Zometa, Bisphosphonates
Aredia is a common bisphosphonate, manufactured by Novartis, and is usually used to treat hypocalcaemia, Paget’s disease, and cancer. In late 2005, the FDA announced that Aredia may contribute to a serious degenerative bone disease known as Osteonecrosis of the Jaw (ONJ). The FDA warned doctors and patients to avoid serious dental procedures while on Aredia because of the possibility of developing ONJ. Common side effects of ONJ include loose teeth, loss of teeth, bleeding or sore gums, exposed bone and excess drainage from the jaw.
Bone Density Drug Aredia May Actually Cause Bone Degeneration
Osteoporosis. Hypocalcemia. Multiple myeloma. Cancer that has metastasized to the bone. These are scary words for patients suffering from bone loss. But patients taking the popular bisphosphonate Aredia have another reason for worry: the drug has recently been linked to osteonecrosis of the jaw (ONJ), a rare condition that actually causes the bone to die within the jaw (in other words, the exact opposite of Aredia’s intended affect). FDA warnings, stringent label requirements and “Dear Dentist” letters are just the beginning of pharmaceutical giant Novartis Pharmaceuticals’ bisphosphonate troubles.
Aredia: Indications and Side Effects
Aredia (pamidronate) was approved by the federal Food and Drug Administration (FDA) in 1991. It is indicated in the treatment of cancer, Paget’s disease, and hypercalcemia, and is administered in a variety of intravenous doses on a monthly basis for the remainder of the affected patient’s life. Aredia is a bisphosphonate drug and works to prevent further bone loss by affecting the metabolic composition of the bone, reversing the body’s process in which it reabsorbs bone tissue and thus increasing bone mass; however, Aredia does not create new bone.
Common Aredia side effects include soft-tissue swelling related at the injection site, generalized pain, nausea and other gastrointestinal symptoms, and occasional seizures, but it is unclear how many of these may be effects of other chemotherapy drugs or the cancer itself. Aredia is no longer marketed in the U.S.
Aredia Linked to ONJ
In May 2005, Novartis and the FDA informed the public that they were changing the labels of Aredia to reflect its connection to the rare bone degenerative condition ONJ. This condition is especially prevalent in patients who take bisphosphonates such as Aredia and Zometa intravenously and is linked in part to long-term consumption of bisphosphonates; a quandary given that lifelong dosage is necessary in order to prevent further bone loss. In Novartis’s statement, they said that between 2002 and 2005, they had received nearly 900 reports of ONJ in Aredia patients, often in patients who were being treated with steroid drugs and chemotherapy solutions simultaneously. While the majority of Aredia ONJ side effects were associated with dental extractions, root canals and other types of oral surgery, some patients who contracted ONJ did not have oral surgery. It is thought that the bone trauma associated with oral surgery puts jaw bone tissue at risk. ONJ causes tissue inside the jaw bone to die and is accompanied by symptoms of swelling and heaviness in the jaw along with loose teeth, poor gum healing and generalized jaw pain.
Unfortunately, bone death is irreparable. Though patients who contract ONJ from Aredia and other bisphosphonates can go on long-term antibiotic therapy and/or seek surgical intervention, there is no way to grow back jaw bone tissue and patients live with the constant threat of infection. A “Dear Dentist” letter issued in 2004 warned dentists about the ONJ risks associated with bisphosphonates and encouraged oral surgeons and dentists to inquire about patients’ drug treatment and cancer histories before operating. In addition, the American Association of Endodontists has issued a position paper urging oral surgeons to consider bisphosphonate patients at ONJ risk.
Have You Been Affected?
If you have experienced ONJ or the other Aredia side effects listed above, get proper medical care immediately. Then contact an attorney with experience in bisphosphonate litigation or Aredia lawsuits. Your Aredia lawyer can help assess your potential claim and tell you whether you might qualify for monetary compensation for your Aredia side effects, including monies for pain and suffering, lost wages, medical bills and hospital stays, and future medical care. Your Aredia 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 Aredia and other oral and intravenous bisphosphonate drugs.