Research shows the osteoporosis drug ibandronate sodium (or ibandronic acid)—sold under the brand name Boniva, Bondronat, and Bonviva—causes atypical thigh bone fractures and osteonecrosis of the jaw (jawbone death).
What Is Boniva? When Is It Prescribed?
Boniva is the brand name for the drug ibandronate sodium. Sold by Swiss pharmaceutical giant Hoffman-LaRoche (and also by the British pharmaceutical company GlaxoSmithKline, Plc.), this prescription medication is used to treat osteoporosis and hypercalcemia. The U.S. Food and Drug Administration (FDA) first approved the drug in May 2003. Hoffman-LaRoche earned about $1 billion in Boniva sales through 2010.
Boniva is a bisphosphonate drug prescribed for post-menopausal women that works by reducing bone degeneration, a process referred to as “resorption.” Related to natural bone-regulating chemicals, the drug does not inhibit bone mineralization. Consequently, one can take ibandronate sodium along with calcium and vitamin D supplements and see some bone mineralization. Unfortunately, the human body does not absorb the drug well, and much of it is excreted through the kidneys. Boniva is sold in 150 mg oral tablets taken monthly. (An earlier daily version of Boniva containing 2.5 mg of ibandronate sodium was discontinued due to safety and efficacy reasons). It must be taken without food, and users must fast for a time to allow the drug to take effect.
Boniva Side Effects
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 mass in the mandible (lower jaw bone) and maxilla (upper jaw bone) die. Usually, this is caused by a badly performed tooth extraction procedure that leaves a portion of jaw bone exposed. It 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. Symptoms include:
- jaw pain
- jaw feeling “heavy”
- gum swelling
- loose teeth
- jaw bone exposure
A study conducted by the American Society for Bone and Mineral Research (ASBMR) found that Boniva 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 announced that it would require a labeling change to all bisphosphonate products, including Boniva. Atypical subtrochanteric femur fractures are very rare, but they appear more common among long-term Boniva takers. The ASBMR study investigated 310 cases of atypical femur fractures, finding that 291 of them were taking a bisphosphonate. Boniva users who experience any thigh pain should contact their physicians promptly.
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 Boniva lawsuit on your behalf if necessary.
If you have taken Boniva and believe it harmed you, contact RLG today.