Generic: Zoledronic Acid
Date approved: 2001
Status: Prescription only
Approved uses: Treatment and prevention of bone loss
Off-Label uses: Anti-fracture uses; however, the anti-fracture properties of bisphosphonates such as Zometa have not been proven
• Osteonecrosis of the Jaw (ONJ)
• bone pain
• tissue death
• loose teeth
• sore gums
• bone loss
• pain and numbness
• difficulty breathing
• bone fractures
• joint disorders
• dental problems
• kidney problems
Zometa, manufactured by Novartis, is a common intravenous bisposphonate similar to Actonel, Aredia, Boniva, and Fosamax. It is prescribed to prevent bone loss, but has very serious side effects including the development of a condition known as Osteonecrosis of the Jaw (ONJ). ONJ causes the jaw bone to degenerate, resulting in serious and irreparable side effects including bone loss, pain, numbness, and exposed bone. Other side effects of Zometa include difficulty breathing, kidney problems and low levels of calcium.
FDA Warns Dentists About Zometa Risks
Millions of cancer patients rely on bisphosphonate drug Zometa to help prevent cancer-related osteoporosis, bone breakage and pain related to bone metastases. But Zometa has come under fire in recent years, with the federal Food and Drug Administration (FDA) warning dentists that the drug is associated with osteonecrosis of the jaw (ONJ), a condition in which the jaw bone dies within the mouth, in a “Dear Dentist” letter.
Zometa (zoledronic acid) is marketed by pharmaceutical giant Novartis and is administered in intravenous form once a month to cancer patients suffering from multiple myeloma, prostate, breast, lung and other cancers. It is also prescribed to some patients for osteoporosis with a once-a-year dose. Nearly 3 million patients have taken an intravenous bisphosphonate such as Zometa. Zometa is the only intravenous bisphosphonate approved for treatment of bone metastases and skeletal events related to multiple types of tumors. Like other bisphosphonate drugs, Zometa prevents bone loss by impacting bone metabolism and preventing the bone’s natural resorption of its own tissue and subsequent loss of bone mass.
ONJ in Zometa Patients
The concern over ONJ is growing in the U.S. and abroad after a multitude of studies since 2003 which show bisphosphonates such as Zometa’s link to jaw bone death after minor trauma such as oral surgery. Symptoms of ONJ include pain and swelling of the jaw, loose teeth, and a feeling of heaviness within the jaw. Usually, ONJ occurs after oral surgery such as implantation or tooth extraction, but some cases of ONJ have been linked to patients who have not undergone oral surgery. ONJ causes irreparable damage; while affected tissue may be removed or treated with long-term antibiotics, dead bone cannot be repaired. While Novartis denies that Zometa actually causes ONJ, multiple studies indicate that users of intravenous bisphosphonates such as Zometa are at a much higher risk of ONJ and other jaw symptoms.
For these reasons, the FDA issued a “Dear Dentist” letter in the United States in late 2005, reminding dentists of Zometa’s new label requirements listing ONJ as a possible Zometa side effect. This letter warned dentists to ask patients about their cancer treatments before attempting oral surgery and to educate patients about ONJ risks with Zometa use. Professional associations and groups of dentists and oral surgeons, such as the American Association of Endodontists, which issued a position statement in March 2006 indicating that oral surgeons should consider bisphosphonate users at risk for ONJ and check with their patients before conducting oral surgery. Though it was initially thought that only intravenous bisphosphonate drugs such as Zometa cause ONJ, it is now accepted by the medical community that patients who take oral bisphosphonates, such as Fosamax, Boniva and Skelid, are at risk for ONJ.
Have You Been Affected?
If you have experienced ONJ or the other Zometa side effects listed above, get proper medical care immediately. Then contact an attorney with experience in bisphosphonate litigation or Zometa lawsuits. Your Zometa lawyer can help assess your potential claim and tell you whether you might qualify for monetary compensation for your Zometa side effects, including monies for pain and suffering, lost wages, medical bills and hospital stays, and future medical care. Your Zometa attorney will walk you through the process of bisphosphonate litigation, help you file a claim, and assist you in taking steps to get the compensation you deserve for the life-altering side effects of Zometa and other oral and intravenous bisphosphonate drugs.