Research shows the osteoporosis drug zoledronic sodium—sold primarily under the brand names Zometa and Reclast, but also as Zomera and Aclasta—might cause atypical thigh bone fractures and osteonecrosis of the jaw (jawbone death).
What Is Zometa? When Is It Prescribed?
Zometa is a brand name for the drug zoledronic sodium. Made and sold by Swiss pharmaceutical company Novartis AG, this prescription medication is used to prevent bone fractures and treat hypercalcemia of malignancy and multiple myeloma with documented bone metastases from solid tumors. The U.S. Food and Drug Administration (FDA) first approved Zometa in August 2001 in the form of an intravenous solution.
Zometa is a member of the bisphosphonate drug class. These drugs are normally prescribed to women who are suffering from osteoporosis. Zometa works by reducing bone degeneration, a process referred to as “resorption.” Related to natural bone-regulating chemicals, the drug does not inhibit bone mineralization, so researchers originally believed it strengthened bones.
Zometa Might Cause Jaw Bone Death, Femur Fractures, and Kidney Impairment
Osteonecrosis of the Jaw
Since 2000, the FDA has known about bisphosphonates’ tendency to cause osteonecrosis of the jaw (ONJ) when they are given to cancer patients. ONJ is a painful, disfiguring bone disease that affects people’s jaw bones—specifically, the bone masses in the mandible (lower jaw bone) and maxilla (upper jaw bone) die. Usually this is prompted by a badly performed tooth extraction procedure that leaves a portion of jaw bone exposed. The area then becomes infected and the jaw bone begins dying off. In extreme circumstances, the patient’s jaw bone must be removed to prevent further bone damage.
- Jaw pain;
- “Heavy-feeling” jaw;
- Gum swelling;
- Loose teeth;
- Numbness; and
- Jaw bone exposure.
A Zometa ONJ multidistrict litigation (MDL) case is pending against Novartis. As of January 11, 2012, it contained 472 active cases. The MDL is located in the U.S. District Court for the Middle District of Tennessee before District Judge Todd J. Campbell. The MDL has proceeded into the bellwether trial phase, and the first one, located in a North Carolina federal court, resulted in a victory for the plaintiff, who convinced the jury that Novartis’ employees deliberately concealed information about Zometa’s safety. The plaintiff’s estate won $13 million: $287,000 for compensatory damages and $12.6 million for punitive damages.
A study conducted by the American Society for Bone and Mineral Research (ASBMR) found that Zometa use correlates to sudden unusual bone fractures, particularly in the thigh bone (femur). The FDA refers to these as “subtrochanteric and diaphyseal femur fractures,” and on October 13, 2010, it issued a Zometa warning and announced that it would require a labeling change to all bisphosphonate products, including Zometa. Atypical subtrochanteric femur fractures are very rare, but they appear to be more common among long-term Zometa takers. The ASBMR study investigated 310 cases of atypical femur fractures, finding that 291 of them were taking a bisphosphonate. Zometa users who experience any thigh pain should contact their physicians promptly.
In September 2011, the FDA issued a specific Zometa/Reclast drug safety communication. In it, the FDA stated that it had approved a label change to include a warning about renal failure. According to the FDA, a January 2009 postmarket safety review found that five people had taken Reclast and suffered renal failure. The Reclast label changed in March 2009 to reflect this. By April 2011, the FDA’s Adverse Event Reporting System logged an additional 11 cases of renal failure, including nine patients who required dialysis due to their zoledronic sodium infusions.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Zometa lawsuit on your behalf if necessary.
If you have taken Zometa and believe it harmed you, contact RLG today.