The osteoporosis drug alendronate sodium (or alendronic acid)—sold under the brand names Fosamax or Fosamax+D—has caused some users to fracture their femurs or experience some other harmful bone-related side effects, according to researchers.
If you have taken Fosamax and you believe it caused you to fracture your femur or suffer some other negative side effect, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group, a Fosamax law firm, knows this, and we want you to believe it. Contact us for a free, confidential consultation.
What Is Fosamax, and What Is It Used For?
Fosamax is the brand name for the drug alendronate sodium. Prescribed for post-menopausal women and men with osteoporosis, Fosamax works by reducing bone degeneration, a process referred to as “resorption.” Related to natural bone-regulating chemicals, the drug does not inhibit bone mineralization. Consequently, one can take alendronate sodium along with calcium and vitamin D supplements and see some bone mineralization. Unfortunately, the human body does not absorb the drug well, and much of it is excreted through the kidneys.
Fosamax was first discovered and sold by the pharmaceutical giant Merck & Co. and was originally approved for sale in the United States by the FDA in September 1995. Merck’s patent for the drug expired in 2008, despite the pharmaceutical company’s appeals to block generic versions of alendronate sodium from going to the market. Now, Barr Pharmaceuticals manufactures the drug as well.
Merck continues to sell Fosamax, and it also combines it with vitamin D, selling it as Fosamax+D. Before losing its patent protection, Merck’s Fosamax sales totaled $3 billion in 2007, and by that time it had been prescribed more than 20 million times.
Fosamax is sold 5mg, 10mg, 40mg, oral tablets taken daily and in 35mg and 70mg oral tablets for weekly use. It must be taken without food and users must fast for a time to allow the drug to take effect.
Fosamax Might Cause Harmful Side Effects, Including Femur Fractures
The U.S. Food and Drug Administration (FDA) has issued numerous Fosamax warnings, but neither Merck nor generic manufacturers have initiated a Fosamax recall. Due to the drug’s numerous bone-related side effects, hundreds of Fosamax lawsuits have been filed, but the Rottenstein Law Group does not know of any Fosamax class action lawsuits. One New York jury awarded a woman $8 million dollars in damages but Merck is appealing the award as excessive.
Since 2000, the FDA has known about Fosamax’s tendency to cause osteonecrosis of the jaw (ONJ) when bisphosphonates are given to cancer patients. ONJ is a painful, disfiguring bone disease that affects people’s jaw bones, specifically the bone mass in the mandible (lower jaw bone) and maxilla (upper jaw bone) die. Usually this is caused by a badly performed tooth extraction procedure that leaves a portion of jaw bone exposed. It then becomes infected and the jaw bone begins dying off. In extreme circumstances, the patient’s jaw bone must be removed to prevent further bone damage. The agency monitored the problem and required a label change on Fosamax in 2005.
More recently, a study conducted by the American Society for Bone and Mineral Research (ASBMR) found that Fosamax use correlates to sudden unusual bone fractures, particularly in the thigh bone (femur). The FDA refers to these as subtrochanteric and diaphyseal femur fractures, and on October 13, 2010, it announced that it would require a labeling change to all bisphosphonate products, including Fosamax. Atypical subtrochanteric femur fractures are very rare, but they appear more common among long-term Fosamax takers. The ASBMR study investigated 310 cases of atypical femur fractures, finding that 291 of them were on bisphosphante. Fosamax users who experience any thigh pain should contact their physicians promptly.
RLG’s Fosamax Lawyers Will Help With Your Fosamax Problems
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Fosamax lawyers at the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process.
If you have taken Fosamax and experienced one of the above side effects, contact RLG today.