Parker, Waichman, Alonso LLP

Home » Topics » Defective Drugs » Zometa

Injured by Zometa?

Novartis and the FDA notified dental healthcare professionals of revisions to the prescribing information about the occurrence of Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, including Zometa (generic: zoledronic acid). The FDA posted a letter from Swiss-based Novartis that was sent to dentists  warning of the problem. The letter also said patients should avoid invasive dental procedures while on the drug.

Officials from the FDA 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 2005. Novartis said it had started studies to see if a link between the jaw problems and Zometa exists. At the time, Novartis officials said they had received 875 reports of osteonecrosis of the jaw from December 2002 through February 2005. Zometa was first put on the U.S. market in 2001 and had more than $1 billion in global sales. Zometa is used in the treatment of hypocalcaemia of malignancy, the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

Osteonecrosis of the Jaw - ONJ
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). 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 ONJ and other oral complications of cancer and cancer therapy.

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