Fosamax Lawsuits
Wednesday, November 26th, 2008Fosamax is a bisphosphonate drug used to maintain and improve the amount of minerals and calcium in the bones. Fosamax is actually the Merck & Co. brand name of the generic drug alendronate. It was designed to help patients with osteoporosis, which reduces bone density. It can also be used to treat osteitis deformans, also known as Paget’s disease. Researchers believe that the drug can start having a positive effect within the first three months of use. It was approved for use by the Food and Drug Administration (FDA) in 1995.
While Fosamax can reverse the reduction in bone density in patients with bone disease, some think it can also have a severe side effect. It is believed that users of Fosamax can develop osteonecrosis of the jaw (ONJ), which is often referred to as “dead jaw.” This involves the very painful death of jawbone tissue. The symptoms of ONJ include pain in the jaw, a feeling of numbness, loosening of teeth, soft tissue infections, and the possible exposure of bone within the mouth.
Studies have shown that there is a link between taking Fosamax and ONJ. It is believed that women taking Fosamax for more than five years are at a higher risk. Some physicians were concerned about the use of Fosamax when the FDA approved it in 2005. This concern was due to the fact that the clinical trials that Merck performed on Fosamax were only for three to five years, which might not have shown true long term effects. When problems started arising, the FDA requested that the labels be changed to warn patients of potential ONJ risk in 2005. Merck & Co. added the warning, perhaps to not only warn patients, but also avoid potential lawsuits.
The May/June 2008 issue of Journal of Orthopaedic Trauma reported fractures occurring in thighbones for no apparent reason and found that 19 of the 20 patients who suffered these fractures had been taking Fosamax for about seven years. The Journal of Clinical Endocrinology & Metabolism reported the cases of nine women taking Fosamax who suffered spontaneous fractures in 2005. Many of the fractures took up to two years to completely heal. In 2006, the Journal of American Medical Association reported the FLEX trial, which showed that women who take Fosamax longer than five years are at the same risk for fractures as those who stopped taking the drug at five years.
A 60 year old woman from Florida filed suit against Merck & Co. After using Fosamax for six years to treat her osteoporosis, she developed a severe case of ONJ, which rotted her mouth and bared the bone in her jaw. It is believed that a total of 655 lawsuits accusing Merck & Co. of not warning patients of the potential hazards of Fosamax have been filed as of June 30, 2008.