Generic: Ibandronate Sodium
Manufacturer: Glaxo SmithKline & Roche
Date approved: 2003
Status: Prescription Only
Approved uses: Treatment of osteoporosis
Off-Label uses: Anti-fracture uses; however, the anti-fracture properties of bisphosphonates such as Boniva 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
Boniva is a common bisposphonate manufactured by GlaxoSmithKline and Roche Holding AG. It is used to treat osteoporosis and is related to drugs such as to Actonel, Fosamax, Zometa, and Aredia. Boniva and the other bisposphonates may cause bone death in patients and has been linked to a condition known as Osteonecrosis of the Jaw (ONJ). ONJ causes bone tissue to die and never regenerate and is often discovered in patients who have dental work while on the drug. Symptoms include pain, numbness, swelling, and exposed bone.
Boniva Linked to Bone Death in Osteoporosis Patients
It has survived a lawsuit from a competitor and is now one of the most commonly-prescribed bisphosphonate drugs on the market…so why is Boniva coming under fire once more? The anti-osteoporosis drug, which is manufactured by Roche Laboratories, Inc. and prescribed to cancer patients and post-menopausal women, has been linked with serious side effects, including osteonecrosis of the jaw (ONJ), a rare condition in which the jawbone dies in the mouth. These Boniva side effects are calling the drug into question, along with an entire class of drugs that have been helping women with osteoporosis since the mid-1990s.
How Boniva Works
Boniva (ibandronate sodium) is available in 150 mg (once-monthly) and 2.5 mg (daily) tablet form and was approved by the federal Food and Drug Administration (FDA) in May 2003. The drug is prescribed for post-menopausal women suffering from decreased bone density and osteoporosis in addition to cancer patients whose cancers have metastasized to the bone. One benefit of Boniva is its once-monthly dosage: it has been indicated that women who take Boniva monthly are more likely to stay on the drug than those who take daily doses of other bisphosphonates. Persistent bisphosphonate treatment can reduce the instance of bone fractures in women with weakened bones. The drug affects bone metabolism, causing the bone to lose tissue less rapidly and thus causing increased bone density, though Boniva does not actually increase bone mass in affected patients.
Boniva’s known side effects include potential esophageal ulcers if the pills become lodged in the throat, thus necessitating taking the drug while in an upright position. The drug is also known to cause problems with patients who have underlying kidney or stomach troubles, instigate allergic reactions in sensitive patients, and/or cause gastrointestinal distress in some patients.
Osteonecrosis of the Jaw
The bombshell burst in 2003, when studies linking bisphosphonate drugs to ONJ surfaced. ONJ is a condition in which the bone dies in the jaw after minor trauma such as dental surgery, implants or other oral surgery, failing to recover and leading to swelling, loose teeth, and eventual bone death. When the jaw bone dies, it is impossible to repair; surgical intervention and long-term antibiotic treatment can help remove the patches of dead bone, but cannot help bisphosphonate patients recover their lost bone. A 2006 study cited by the United Press indicated bone death in over 2500 patients, over 120 of whom were taking bisphosphonates in an oral form, since 2001, and these figures are gaining momentum as more and more patients report ONJ to doctors. The American Association of Endodontists now recommends that oral surgeons consider patients who take bisphosphonates like Boniva to be at significant risk for ONJ.
Though Roche Laboratories has yet to be sued for ONJ side effects of Boniva, it was involved in a lawsuit in early 2006 when rival drug manufacturers Proctor & Gamble and SanofiAventis accused Roche of mounting an “intentional campaign” to tell patients and doctors alike that the drug has the same benefits as other bisphosphonates such as Fosamax and Actonel, even though its chemical structure is significantly different. Roche in turn claimed that its competitors had smeared the drug’s name by telling doctors not to prescribe it because they would be sued for malpractice because of Boniva side effects. The lawsuit also claimed that Boniva’s manufacturers were threatening consumers with severe health risks and misrepresenting scientific studies about Boniva’s efficacy. However, the U.S. District Court rejected the proposed injunction in September 2006 and accused Proctor & Gamble and SanofiAventis of trying to undermine Boniva’s market share and preserve the popularity of their own bisphosphonate drugs.
Have You Been Affected?
If you have experienced ONJ or the other Boniva side effects listed above, get proper medical care immediately. Then contact an attorney with experience in bisphosphonate litigation or Boniva lawsuits. Your Boniva lawyer can help assess your potential claim and tell you whether you might qualify for monetary compensation for your Boniva side effects, including monies for pain and suffering, lost wages, medical bills and hospital stays, and future medical care. Your Boniva 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 Boniva and other bisphosphonate drugs.