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Injured by Aredia?

Aredia was approved by the FDA in 1991 and is produced by Novartis. Aredia is used to treat Hypercalcemia, Paget's disease, and Cancer.

On May 18, 2005, Novartis and the FDA informed dental healthcare professionals of amendments to the prescribing information to describe the occurrence of osteonecrosis of the jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, Aredia (pamidronate disodium). The letter also said patients should avoid invasive dental procedures while on the drug. Novartis first warned of the jaw ailment in September 2004 and made doctors and dentists aware of the side effect.

However, FDA officials said they were concerned that many dentists and patients were not aware of the potential for jaw problems. The issue was discussed at an FDA advisory panel meeting in March. Novartis said it had started studies to see if there's a link between the jaw problems and patients taking Aredia.

Novartis officials said they had received 875 reports of Osteonecrosis of the jaw (ONJ) from December 2002 through February 2005. Aredia was first approved by the FDA in 1991, but it is no longer marketed in the U.S. Aredia is used in the treatment of hypocalcaemia of malignancy, Paget’s disease, osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma.

Osteonecrosis of the jaw (ONJ) has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis.

A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene).

Osteonecrosis of the jaw (ONJ) is a complex problem with multiple risk factors. Typical signs and symptoms of ONJ include, but are not limited to: pain, swelling, or infection of the gums; loosening of the teeth; poor healing of the gums; numbness or a feeling of heaviness in the jaw; drainage and exposed bone. The seriousness of ONJ ranges from patient being asymptomatic to requiring sections of the jaw to be removed.

Dentists, oral surgeons, periodontists, prosthodontists, dental hygienists, and other dental health professionals can play a vital role in identifying Osteonecrosis of the jaw (ONJ) and other oral complications of cancer and cancer therapy.

If you or a loved one took Aredia and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.