Bisphosphonate Litigation Moving Forward, As FDA Approves Generic Boniva

The U.S. Food and Drug Administration (FDA) this week approved the first generic versions of the bisphosphonate, ibandronate (Boniva). The announcement comes just as litigation involving bisphosphonate side effect lawsuits is heating up in both state and federal courts.

Ibandronate is a once-month pill used to treat osteoporosis in post-menopausal women. According to an FDA press release issued yesterday, Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. are the manufacturers that have gained FDA approval to make generic 150 milligram bisphosphonate ibandronate tablets. As is the case with all bisphosphonates, patients prescribed the generic ibandronate 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.

The FDA’s announcement was issued just as the first Fosamax trial in a New Jersey mass tort entered its second week. The case alleges the bisphosponate Fosamax caused plaintiffs to suffer a serious bone disorder called Osteonecrosis of the Jaw (ONJ or dead jaw syndrome). Lawsuits pending in the mass tort that allege Fosamax caused users to sustain atypical femur fractures are expected to commence in the fall.

Numerous Fosamax lawsuits have also been consolidated in a multidistrict litigation in U.S. District Court, District of New Jersey before the Honorable Garrett E. Brown, Jr. (“MDL No. 2243). In an order dated February 12, 2012, that litigation was expanded to include claims filed by people who had used either Fosamax, or Fosamax and Boniva.

Boniva and Fosamax are approved to treat bone disorders, including osteoporosis in post-menopausal women, and Paget’s disease. Other bisphosphonates of this type include the drugs Actonel, Didronel and Skelid. The IV-administered bisphosphonates, Aredia, Bonefos, and Zometa, are used to prevent fractures due to bone metastases in cancer patients.

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. In 2005, warnings about ONJ were added to labels for Fosamax and other bisphosphonates.

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