FDA orders change in labels of bisphosphonate

Food United States and drugs (FDA) has announced that additional information will be added to labels of the following bisphosphonate medications prescribed for osteoporosis patients: Fosamax, Fosamax Plus D, Actonel, Actonel with calcium, Boniva, Atelvia, Reclast and their generic equivalents. The information in question shall notify consumers of the risk of atypical femur fractures (subtrochanteric and diaphyseal femur fractures) in patients taking bisphosphonates.

Subtrochanteric femur fractures occur in the bone, directly below the hip joint. Diaphyseal femur fractures are found along the length of the femur. Both are extremely rare: together account for less than 1% of all hip and femur fractures.

The FDA recommends that patients continue taking their prescribed medications unless they advised to stop by their doctors. Patients suffering from side or adverse effects as a result of taking bisphosphonates should communicate with their doctors, well as the FDA MedWatch safety information and adverse program reports the event to the 1-800-332-1088.

Drug manufacturers are responsible for ensuring that their products are safe. Injuries caused by defective drugs may be cause for a personal injury lawsuit. For more information visit the section of the guide his Legal on defective drugs. Your Legal Guide also offers extensive information on other areas of law, such as family law, DUI and goes bankrupt.

This entry was posted on Wednesday, October 13, 2010 at 6: 43 pm and is filed in Uncategorized. You can follow any responses to this entry through the RSS 2.0 source. Comments and pings are currently closed.


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