Consumer Alert: Osteonecrosis is associated with cancer care drug, Zometa
Novartis Pharmaceuticals is the developer of cancer care drug, Zometa (Zoledronic Acid). It is a biphosphonate used to treat hypocalcemia (low levels of calcium in the blood) in certain cancer patients, bone fractures and bone pain in cancer patients, multiple myeloma, and bone metastases from cancerous tumors in the prostrate, lungs, and breasts [i]. It is often administered through an IV, but also taken orally.
In September 2003, the Zometa information package was updated to include information regarding osteonecrosis of the jaw [ii]. In August 2004, Novartis made additional revisions to the Zometa label under the "Precautions" and "Adverse Effects" areas indicating the risks of Jaw Necrosis [ii]. The revision stated, "Osteonecrosis of the jaw has been reported in patients with cancer receiving treatment regimens including biphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of these cases are associated with dental procedures. Many patients had signs of local infection including osteomyelitis" [iii].
To confirm the risks of osteonecrosis while taking Zometa, studies were conducted and published in the Journal of Oral and Maxillofacial Surgeons. Because these studies confirmed the risks of osteonecrosis, the US Food and Drug Administration and Novartis Pharmaceuticals issued a warning to the health community in September 2004 [iv].
In addition to the osteonecrosis, other debilitating side effects include:
Sores, ulcers, bleeding and bruising, fever and other flu-like symptoms, conjunctivitis, nausea, constipation, diarrhea, abdominal pain, chest pain, vomiting, weight loss, loss of appetite, hypotension, anemia, yeast infection (thrush), Hypophosphatemia (deficiency of phosphates in blood), hypokalemia (low levels of potassium in the blood), hypomagnesaemia (low levels of magnesium in the blood), skeletal pain, insomnia, anxiety, confusion, agitation, dyspnea, coughing, dehydration, urinary tract infection, Hypocalcaemia, pleural effusion, loosening of teeth, and jaw necrosis* [v].
*Jaw Necrosis is decay of the jaw bone, which leads to dead bone of the jaw. Symptoms include: jaw pain, inflammation, loosening teeth, and/or numbness/heaviness in the jaw region [vi].
If you or a loved one has been taking Zometa and experienced any of the above side effects, please contact us.
- Zometa. (2002). United States Food and Drug Administration.
http://www.fda.gov/cder/consumerinfo/druginfo/zometa.HTM - Oncologic Drugs Advisory Committee. (2005). Briefing Document: General Background Document: Aredia and Zometa. Rockville, MD.
http://www.fda.gov/ohrms/dockets/ac/05/briefing/
2005-4095B2_03_02-FDA-TAB1.pdf - Scher, Nancy, A. (2005). Regulatory History of Zometa and Aredia Jaw Osteonecrosis. Food and Drug Administration Oncologic Drug Advisory Committee. Chevy Chase, MD.
http://www.fda.gov/ohrms/dockets/ac/05/slides/
2005-4095S2_03_01-FDA-Scher-N_files/frame.htm#slide0009.htm - Hohnecker, John. (2004). Dear Healthcare Professional Letter. Novartis Pharmaceuticals: East Hanover, NJ
http://www.fda.gov/medwatch/SAFETY/2004/ZometaHCP.pdf - Oral Maxillofacial Surg. 2004 May; 62(5):527-34. Related Articles, Osteonecrosis of the jaws associated with the use of bisphosphonates: a review of 63 cases. Ruggiero SL, Mehrotra B, Rosenberg TJ, Engroff SL, Division of Oral and Maxillofacial Surgery, Long Island Jewish Medical Center, New Hyde Park, NY 11040, USA.
- Novartis Pharmaceuticals. (2005). Zometa Drug Description. Novartis Pharmaceuticals: East Hanover, NJ.
http://www.fda.gov/cder/foi/label/2001/21223lbl.pdf