Fosamax Label Change

According to the U.S. Food and Drug Administration (FDA), the warnings and precautions section of labels for drugs treating osteoporosis will be changing. The change will describe the risk of subtrochanteric and diaphyseal femur fractures for patients who take bisphosphonates to treat osteoporosis. Fosamax bottles will reflect this addition, as will other medications such as Actonel, Boniva, Atelvia, and Reclast (and their respective generic products). The FDA will also require pharmacies and doctor’s offices to give patients a medication guide when they pick up their prescription for a bisphosphonate product.

Fosamax has been linked to the deterioration of other bones besides the femur in the body, such as the mouth and jaw. Millions of women have been prescribed this bisphosphonate product; and there is now evidence that shows osteoporosis patients prescribed Fosamax are likely to suffer femur fractures. A report from the American Society of Bone and Mineral Research studied 310 osteoporosis patients that suffered a rare femur fracture, such as subtrochanteric and diaphyseal fractures, and found that 94 percent of them had been taking a bisphosphonate drug, such as Fosamax. These types of femur fractures are very uncommon, accounting for less than one percent of all hip and femur fractures. While it is not clear if bisphosphonate products such as Fosamax are the cause of these rare femur fractures, patients taking bisphosphonate products are among those that predominantly report them.

The FDA recommends that healthcare professionals stop prescribing antiresorptive medications, including bisphosphonates, in patients who show risk of femur fractures.

The Fosamax lawyers at Anapol Weiss can help those adversely affected by the dangerous drug and can help them obtain compensation for their injuries.

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