The lawyers at Goza & Honnold, LLC are working to help those who have suffered a femur fracture after taking Fosamax®. Merck developed and marketed Fosamax® for the treatment and prevention of osteoporosis. Fosamax® and similar drugs called bisphosphonates were developed to improve bone mineralization by inhibiting the bone-reabsorbing activity of a cell called an osteoclast.
After priority review of Merck's application, the FDA granted approval for Fosamax® in 1995. It was the first oral bisphosphonate approved for the treatment of osteoporosis in the U.S. Merck later received FDA approval for Fosamax® use in osteopenia, to prevent osteoporosis, an even broader indication. The approval of Fosamax® was not based on a reduction in clinical fractures, but instead was based on the drug's effects on x-ray images of bone.
There are now four bisphosphonates approved for marketing in the U.S. They are sold under the brand names of Fosamax® (Merck & Co.), Actonel® (Warner Chilcott, Plc.), Boniva® (Roche Holdings AG), and Reclast® (Novartis AG). Fosamax® is now available as generic alendronate. These bisphosphonate drugs are prescribed to millions of people worldwide, the majority of whom are women. Because of their widespread use, the safety of these osteoporosis drugs is an important public health issue.
Safety is the primary responsibility of the drug manufacturers, but they rely on the income these drugs produce. In 2010 the U.S. sales of Fosamax® and other bisphosphonates was $4.2 billion, and sales were $7.6 billion worldwide. Fosamax® reached peak sales in 2005, when it generated over $3 billion for Merck.
Individuals taking Fosamax® for osteoporosis or osteopenia may experience an unusual type of fracture in their femurs or thigh bones. These atypical femoral fractures may have characteristic clinical and radiographic features. Patients may experience thigh pain before the fracture occurs and often both femurs are affected. These fractures are often times associated with minimal or no trauma. In fact, some individuals have suffered fractures while simply standing.
The risk of these atypical fractures appears to increase with long-term use of Fosamax® and similar bisphosphonates. The benefit of long-term use of these drugs has therefore been called into question, especially in light of the drugs' association with these fractures. On September 9, 2011, a panel of experts met with the Food and Drug Administration to discuss new safety warnings for the four approved osteoporosis drugs. The panel recommended that the FDA require manufacturers of these drugs to warn doctors and patients of the risk of these atypical fractures and other problems associated with long-term use of the drugs.
For additional information, please visit the FDA's website regarding their safety update for osteoporosis drugs, bisphosphonates, and atypical fractures at http://www.fda.gov/Drugs/DrugSafety/ucm229009.htm
