Zometa (zoledronic acid)

Zometa (zoledronic acid) is an intravenous bisphosphonate drug used to treat the bone-destroying activity that occurs with bone metastases, fight the abnormal cells that cause bone to wear away (osteolytic lesion), and treat multiple myeloma (tumors formed by the cells of the bone marrow) and hypercalcemia (excess calcium in the blood) that occurs with some types of cancer. Manufactured by Novartis Pharmaceuticals, Zometa works by reducing the amount of calcium released from bones into the blood.

Why Prescribed

Zometa is prescribed to reduce the risk of bone complications such as bone fracture‚ hypercalcemia of malignancy‚ and spinal cord compression in patients who suffer from prostrate cancer and multiple myeloma.

FDA Approved Uses

Zometa was approved by the FDA in 2001 for treating hypercalcemia, and in 2002 for the treatment of bone metastasis.

Side Effects

Commonly reported side effects with Zometa include flu-like symptoms (nausea and vomiting, fever, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema, and pain/redness/swelling at the injection site.

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Warnings and Alerts

In September 2004, Novartis Pharmaceuticals and the FDA notified dental healthcare professionals of revisions to prescribing information to describe the occurrence of Osteonecrosis of the Jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates such as Zometa. The revised prescribing information recommends that cancer patients receive a dental examination prior to starting bisphosphonate treatment, and that they avoid invasive dental procedures while on these medications.

Drug Contraindications

Zometa is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates.

FAQ's

What should I tell my doctor before he or she prescribes Zometa?

Before taking Zometa, you should tell your doctor if you are on medications used to treat high blood calcium or osteoporosis, if you are allergic to any substances (foods, preservatives, or dyes), are pregnant or planning to become pregnant, are breast-feeding, have asthma, have heart disease, have kidney disease, have cancer or are undergoing cancer treatment, are planning to have dental procedures or surgery while receiving Zometa treatment, have poor dental hygiene, experience dehydration, or have liver problems.

Are there adverse side effects associated with Zometa?

In addition to ONJ, Zometa may cause serious side effects including red, swollen, or teary eyes, stomach pain, difficulty swallowing, mouth sores, white patches in the mouth, irritation, burning, or itching of the vagina, white vaginal discharge, and hair loss.

Are there patients who are more at risk for developing ONJ?

Patients most at risk for developing ONJ include those who:

• Have taken bisphosphonates
• Have taken steroids at or near the same time
• Have a previous history of cancer, osteoporosis, or Paget's disease
• Have undergone invasive dental procedures, including extractions and/or dental implants

How can I tell if I have ONJ?

The symptoms of ONJ include:

• An irregular sore with exposed bone in either the upper or the lower jaw
• Pain in the infected jaw
• Loosening of teeth
• Evidence of infection, including fever and possible pus discharge
• Numbness, tingling, or other sensation changes

Can I file a lawsuit if I have been injured as the result of taking Zometa?

Patients injured by unsafe products are ordinarily entitled to recover monetary damages for all losses and expenses suffered from use of the product. Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

• Past and future medical expenses
• Past and future pain and suffering
• Lost wages
• Loss of future earning capacity
• Emotional distress

Like other bisphosphonates, Zometa is metabolized very slowly by the system and may remain in the body for ten years or more- prolonging the risk of ONJ long after the patient stops using it.

If you have in fact been injured and/or have been diagnosed with ONJ as the result of using Zometa, you have legal rights and should contact a qualified drug litigation attorney to discuss your legal claim. As all legal claims are subject to time limits, you may risk forfeiture of your right to financial compensation if you delay.