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Aredia (pamidronate disodium) is a bisphosphonate, a class of drugs that includes Fosamax, Actonel, and Zometa. Along with Zometa, Aredia is an intravenous bisphosphonate. Aredia, which is made by Novartis and was approved by the US Food and Drug Administration (FDA) in 1991, is used to treat hypercalcemia, osteoporosis, Paget's disease, and certain kinds of cancer.
After its clinical trials, it was known that Aredia was associated with the deterioration of renal function, potential fetal harm in pregnant women, musculoskeletal pain, hypocalcemia, and osteonecrosis of the jaw (ONJ). ONJ is a condition in which bone tissue of the jaw loses blood, leading to its death and eventual collapse. In some cases, sections of the jaw are required to be removed.
It was also known that the drug was contraindicated for patients with clinically significant hypersensitivity to bisphosphonates and that caution had to be taken with those taking other potentially nephrotoxic (toxic to the kidney) drugs and multiple myeloma (malignant tumor formed by plasma cells) patients also taking thalidomide (a sedative-hypnotic drug). Other common side effects of Aredia include nausea, dizziness and flu-like symptoms.
An alarming number of reports regarding the occurrence of ONJ observed in cancer patients receiving treatment with intravenous bisphosphonates, however, prompted the FDA in May 2005 to notify dental healthcare professionals of revisions to Aredia's prescribing information. The information recommends that cancer patients receive a dental examination prior to initiating therapy with Aredia, and that invasive dental procedures be avoided on patients receiving treatment with Aredia. It also warns that dental surgery could exacerbate ONJ in patients who developed the condition while on bisphosphonate therapy.
Novartis had first made similar warnings to doctors and dentists in September 2004. But FDA officials expressed concerns that a large number of dentists and patients remained unaware of the risk for jaw problems. Aredia is no longer marketed in the United States.
If you or a loved one is suffering from ONJ or any other serious side effect after being prescribed Aredia, you may have a claim to compensation. To understand your legal rights and options, contact a qualified pharmaceutical injury attorney. But we suggest you do so sooner, rather than later, because there are legally defined time limits by which you may file a claim.