FDA safety information on Boniva
Boniva was approved by U.S. Food and Drug Administration (FDA) in May 2003. Since then it has been linked with many side effects. Boniva is the brand name for ibandronate. It belongs to the bisphosphonates group of medicines. It is used for treatment of osteoporosis in women after menopause. It also prevents osteoporosis by affecting the bone formation and breakdown cycle. It slows down the process of bone loss and can even increase bone mass. This alteration prevents bone fractures. Though it is mainly used to treat osteoporosis, it is also used for other purposes as well. The chemical name of ibandronate sodium is 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1, 1diphosphonic acid. It is monosodium salt, monohydrate and its chemical formula is C9H22NO7P2Na•H2O.
From time to time, the FDA has issued different warnings and instructions to alert consumers and physicians of the adverse effects of this drug. The FDA issued a notice regarding label changes of Boniva in November 2008. These changes were approved by the FDA Center for Drug Evaluation and Research (CDER). These new warning labels included adverse reactions in the upper gastrointestinal area, hypocalcemia, mineral metabolism and musculoskeletal pain. The label also warned of adverse effects of Boniva such as ocular adverse events and acute phase reaction.
Later reports started pouring in regarding more adverse side effects of Boniva. It was linked to bone death in osteoporosis patients. It forced FDA to conduct a safety study. FDA reviewed all the available data. This data included data summarized in the American Society for Bone and Mineral Research (ASBMR) Task Force report on bisphosphonates side effects resulting in atypical femur fractures. This report came to public view on September 14, 2010. These atypical femur fractures can occur anywhere and can be complete or incomplete. Many patients felt dull pain in the affected area or aching thigh pain before these fractures occur. Though atypical femoral fractures occur in other patients too, but they were more common in patients taking bisphosphonates drugs like Boniva.
In October 2010, the FDA asked the manufacturer of Boniva to add a warning regarding risk of atypical femur fractures. Bisphosphonate drugs such as Boniva are used to treat or prevent osteoporosis. They can prevent or slow the loss of bone mass women post menopause. Thus, they reduce the risk of osteoporosis bone fracture. In atypical subtrochanteric femur fractures, the bone fractures just below the hip joint. On the other hand diaphyseal femur fractures are fractures in the long part of the thighbone.
The FDA asked patients who are using Boniva to continue medication if their doctor finds it fit for them. They should seek medical help if they develop a new hip or thigh pain. The FDA also asked healthcare professionals to be aware of the possible risk of atypical subtrochanteric and diaphyseal femur fractures after use of Boniva. They were asked to be fully informed on warnings and precautions on the drug label. They should prescribe Boniva to patient only after evaluating its pros and cons and discussing its side effects with the patient. They should also monitor patients for any side effects from time to time.
The FDA is continuing its safety review of bisphosphonate use and its side effects, including the occurrence of atypical femur fractures. The FDA has asked for a Medication Guide to be included with all bisphosphonate medications approved for osteoporosis, so that patients are well informed of its side effects.