Boniva

Boniva is a bisphosphonate medication with the active ingredient ibandronate, which is one of seven bisphosphonates currently approved by the FDA and sold under varying brand names including Fosamax® and Actonel®. Unfortunately, like other bisphosphonate drugs used in postmenopausal women to treat osteoporosis, Boniva is a dangerous medication that has many side effects about which patients were not warned.

Pharmaceutical companies have sold more than $4.6 billion worth of bisphosphonates to the public, marketing these medications without letting patients know of serious potential dangers they could face. If you or a loved one was one of the many who was prescribed Boniva and who has been harmed as a result, contact the Boston personal injury lawyers at the Jeffrey Glassman Injury Lawyers.

The Food and Drug Administration (FDA) has listed five potentially serious side effects in its medication guide for Boniva. The manufacturer is obligated to warn patients about the increased risk of:

• Esophageal damage. Boniva can cause irritation, inflammation, esophageal ulcers and sometimes bleeding. Damage over time can result in esophageal cancer.
• Hypocalcaemia. Boniva can lower calcium levels, which can cause numbness in the fingers, toes and mouth, and which can cause muscle cramps and spasms. Those who already have low blood calcium levels will find their conditions exacerbated by Boniva.
• Joint and muscle bone: This pain is described by the FDA as “severe.”
• Osteonecrosis. Also called dead jaw syndrome, this refers to damage to the jaw bone that is slow to heal. It usually occurs after a tooth is pulled or when dentures rub against the mucosa of the mouth.
• Unusual fractures in the thigh bone: Abnormal femur fractures can cause significant discomfort in the hip, groin and thigh. A May 2008 study in the Journal of Orthopaedic Trauma reporting on 20 patients with a femur fracture found that 19 of the patients had been using a bisphosphonate medication fro an average of 6.9 years.

The FDA describes these side effects as serious but rare. However, studies have indicated that many patients have been harmed as a result of complications of Boniva and other bisphosphonate drugs. A 2009 study published in the Journal of American Dental Association, for example, indicated that four percent of healthy patients studied by the University of Southern California’s school of dentistry had jawbone infections resulting from the oral use of bisphosphonates.

An FDA official also wrote a letter to the New England Journal of Medicine warning that the agency had received a total of 23 reports of a link between one bisphosphonate drug (Fosamax) and esophageal cancer. Although the FDA did not confirm that Boniva was a potential cause of esophageal cancer, the FDA official’s letter said that this link couldn’t be ruled out. The number of complaints of esophageal cancer related to osteoporosis medications has since increased to around 30 reports.

Many patients prescribed Boniva were not aware of the dangers, which can be exacerbated through long-term use. Unfortunately, as more and more people have now taken the drug for many years, there have been increasing complications and more claims are being made against the drug manufacturer.

If you or a loved one is among the patients who took Boniva and who is experiencing health problems as a result, you may have a legal right to compensation. Under product liability rules for defective drugs, you don’t have to prove the manufacturer was negligent but you do have to demonstrate that the Boniva was the direct cause of health issues when used as directed.

The defective drug attorneys at Jeffrey Glassman Injury Lawyers can help you with your personal injury claim arising from Boniva or other dangerous medications. Give us a call or contact us online today to learn more and schedule your free consultation.

Reference:

http://www.mayoclinic.com/health/fosamax/AN01379

http://www.nejm.org/doi/full/10.1056/NEJMc0807099

http://journals.lww.com/jorthotrauma/pages/articleviewer.aspx?year=2008&issue=05000&article=00011&type=abstract

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241518.pdf