Novartis and the FDA have notified dental healthcare professionals of new prescribing information that described the occurrence of Ostoenecrosis of the jaw (ONJ) observed in cancer patients undergoing treatment with intravenous bisphosphonates, marketed as Aredia (pamidronate sodium).
A letter was posted on the FDA web site that was also sent to dentists by the Swiss based drug manufacturer Novartis warning of this issue. It also stated that patients should avoid invasive dental procedures while using the medication. Novartis first warned doctors and dentists of the problem in September 2004.
Still, the FDA stated concerns that many dentists and patients were not fully aware of the potential for serious adverse jaw problems. After a discussion in an FDA advisory meeting in March 2005, Novartis stated they had begun studies to determine if there is a link between Aredia and ONJ. At that time, Novartis stated that it had received 875 reports of ONJ from December 2002 and February 2005.
Aredia was first approved for use in the US by the FDA in 1991, but it is no longer marketed in the US. Aredia was utilized for the prevention of hypocalcaemia of malignancy, Paget's disease, osteolytic bone metastases of breast cancer, and osteyltic lesions of multiple myeloma.
A dental exam with appropriate preventive dentistry should be considered before treatment with bisphosphonates.
The majority of reported ONJ related problems were connected to tooth extractions, but clearly all major invasive dental procedures could result in the condition if done concurrently with the use of bisphosphonates like Aredia.
ONJ is a complex health issue with multiple risk factors. Symptoms include pain, swelling, or infection of the gums, numbness or a sensation of heaviness in the jaw, fluid drainage and bone exposure, among others. The seriousness of the condition ranges from those with relatively little or no symptoms to those requiring surgical resection of the jaw.
Register your Aredia ComplaintIf you or a loved one has suffered from Ostoenecrosis of the jaw, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please fill in our form on the right to submit your complaint and we will have a lawyer review your Aredia complaint.
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