Thousands of Fosamax lawsuits have been filed against Merck & Co. for femur fractures, jaw bone decay (Osteonecrosis of the Jaw), and other severe side effects. Lawsuits allege that Merck failed to warn that long-term use of Fosamax (beyond 3-5 years) significantly increases the risk of side effects.
Jury Awards $285,000 for Fosamax Lawsuit
In February 2013, a federal jury ordered Merck & Co. to pay $285,000 to resolve a Fosamax lawsuit involving jaw bone decay. The 8-person jury in Manhattan found that Merck failed to warn about the risk of Osteonecrosis of the Jaw (ONJ), which caused the 69 year-old plaintiff to develop severe bone disease after a tooth extraction. Merck also lost a Fosamax lawsuit in 2010, when a jury in Florida awarded Shirley Boles $8 million, though a judge later cut that sum to $1.5 million.
What is Fosamax?
Fosamax (alendronate), developed by Merck & Co, was approved by the FDA in 1995 to strengthen bones. It belongs to a class of drugs known as bisphosphonates, which are used to increase bone density. This treats osteoporosis (bone loss) in men and post-menopausal women and other bone diseases. It is a former blockbuster drug that generated $23.8 billion in global sales from 1999 to 2009.
What is the problem?
Bones are in a constant state of destruction and re-growth. Fosamax works by slowing resorption, the breakdown phase of normal bone remodeling. In the short-term, slowing bone resorption increases bone density. But long-term, it may impair new bone growth and reduce the bone’s ability to repair microscopic cracks from normal wear and tear. Over time, these small cracks could accumulate and cause a fracture. Fosamax may also affect the mineralization process, resulting in bones that are more brittle.
Fosamax and Jaw Bone Death (Osteonecrosis of the Jaw)
Since 2001, there have been over 2,400 repots of jaw bone decay or death in patients using Fosamax. This condition, known as Osteonecrosis of the Jaw (ONJ), exposes an area of the jawbone that is not covered by the gums. It occurs when the jaw bone is unable to repair itself and has less blood vessel formation. ONJ may occur within 12 months of using Fosamax, and the risk increases the longer Fosamax is taken.
Signs & symptoms of ONJ:
- Exposed jaw bone does not heal within 8 weeks
- Jaw pain
- Loosening of the teeth
- Swelling or infection of the hums
- Poor healing gums
- Drainage from gums
- Feeling of heaviness in the jaw
- Exposed gums
- Dead jaw
Fosamax and Femur Fractures
Long-term use of Fosamax is associated with an increased risk of “low-energy” femur fractures, which means they occur without serious trauma. In 2008, a study published in the New England Journal of Medicine found that post-menopausal women who used Fosamax for an extended period of time were more likely to have atypical femur fractures caused by falls from standing height or lower.
Another study, published in the Journal of the American Medical Association in February 2011, found nearly a tripled increased risk of femur fractures from Fosamax and other bisphosphonate drugs over five years. These femur fractures were unusual because they occurred while walking or descending stairs, without the extreme force typically needed to break the thigh bone.
FDA Warning for Fosamax Femur Fractures
In 2010, the FDA published a Drug Safety Communication for Fosamax and other bisphosphonate drugs to warn that they can increase the risk of atypical femur fractures if they are used for a long period of time. In May 2012, the FDA also published a report in the New England Journal of Medicine recommending against using Fosamax any longer than 3-5 years because long-term use does not reduce the risk of fractures.