Parker Waichman LLP Questions FDA Approval of Generic Bisphosphonate Drug Boniva, as Major Bisphosphonate Side Effect Trial Enters its Second Week

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According to Parker Waichman LLP, the FDA Approved Generic Versions of the Bisphosphonate, Boniva, while a Major Bisphosphonate Trial Underway in New Jersey State Court Regarding Serious Side Effects, enters its Second Week

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“Considering there are so many unanswered questions about Boniva and other bisphosphonates, we are frankly surprised that the FDA granted the generic applications,”

Parker Waichman LLP, a national law firm representing people injured by defective drugs, announces that the U.S. Food & Drug Administration (FDA) has approved the sale of the first generic bisphosphonate versions of ibandronate (Boniva) tablets, a once-monthly bisphosphonate medication used to prevent osteoporosis in women after menopause. Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. are the manufacturers that have gained FDA approval to make generic 150 milligram bisphosphonate ibandronate tablets. According to the agency, patients prescribed a generic version of the bisphosphonate drug Boniva will be given an FDA-required Medication Guide that details, among other things, the drug's serious side effects including: esophagus problems; low calcium levels in the blood; bone, joint, or muscle pain; severe jaw bone problems; and unusual thigh bone fractures. []

In October 2010, the FDA asked the manufacturers of bisphosphonates used to treat osteoporosis, including Fosamax and Boniva, to add information to the "Warnings and Precautions" section of the drugs’ labels describing the risk of atypical thigh fractures after a study linked long-term use of such drugs to this side effect. [] Lawsuits involving alleged bisphosphonate Fosamax side effects have been designated a mass tort in the Superior Court of New Jersey, Law Division, Atlantic County, (In re: Fosamax Litigation (No. 282 NJ. Super. Ct.) before the Honorable Judge Carol Higbee. The first jury trial in that litigation, which alleges Fosamax caused plaintiffs to suffer a serious bone disorder called Osteonecrosis of the Jaw (ONJ or dead jaw syndrome), began on February 27, 2012, and has now entered its second week. According to Parker Waichman LLP, trials of lawsuits alleging Fosamax caused users to sustain atypical femur fractures are expected to commence in the fall.

Additional lawsuits involving bisphosphonates have also been consolidated in a multidistrict litigation U.S. District Court, District of New Jersey before the Honorable Garrett E. Brown, Jr. (“MDL No. 2243). Originally, that litigation involved on the bisphosphonate, Fosamax. But in a order dated February 12, 2012, the U.S. Judicial Panel on Multidistrict Ltigation expanded the MDL to include claims filed by people who had used either Fosamax, or Fosamax and Boniva. [] Both bisphosphonates Boniva and Fosamax are approved to treat bone disorders, including osteoporosis in post-menopausal women, and Paget's disease.

A study published in the Journal of the American Medical Association (JAMA) entitled, "Bisphosphonate Use and the Risk of Subtrochanteric or Femoral Shaft Fractures in Older Women," [] concluded that women on bisphosphonate therapy for osteoporosis for 5 years or longer had a higher chance of subtrochanteric or femoral shaft fracture.

Dead jaw syndrome is a rare bone disease that can cause a victim’s jaw bone to deteriorate and die. Symptoms of ONJ include infection, pain or swelling in the infected jaw, exposed oral bones, numbness and loss of teeth. The condition often requires victims to undergo painful surgery to remove dying bone tissue. The FDA ordered that warnings be added to the labels of Fosamax and other bisphosphonates regarding their risk of ONJ in July 2005. []

“Considering there are so many unanswered questions about Boniva and other bisphosphonates, we are frankly surprised that the FDA granted the generic applications,” states Matthew McCauley who is the leading attorney in the bisphosphonate litigation at Parker Waichman LLP. “We hoped that an updated label would have preceded such an approval so that the patients were better informed. It was the perfect opportunity to get the “warning” out to physicians and users of these products.”

Parker Waichman LLP continues to offer free legal consultations to victims of bisphosphonate side effects. If you or a loved experienced an atypical femur fracture or developed ONJ, and you believe Fosamax, Boniva or another bisphosphonate is to blame, please contact their office by visiting the firm’s bisphosphonate side effects page at Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

For more information regarding bisphosphonates Fosamax side effect lawsuits and Parker Waichman LLP, please visit: or call 1-800-LAW-INFO (1-800-529-4636).

Parker Waichman LLP
Herbert Waichman, Partner
(800) LAW-INFO
(800) 529-4636

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Herb Waichman, Partner
Parker Waichman Alonso LLP
(800) 529-4636
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