The Fosamax FDA femur warning issued in October 2010 was intended to alert the public to the risks of developing subtrochanteric and diaphyseal femur fractures as a result of taking the biphosphonate medication Fosamax, or its generic equivalent, Alendronate.
Fosamax was intended to strengthen bones and was FDA approved in 1995 for the treatment of osteoporosis and Paget’s disease (a condition marked by abnormal and enlarged bones). Unfortunately for its users, Fosamax can cause femur fractures that affect the long area of the thigh bone, which is one of the strongest bones in the body. Although femur fractures usually result from highly traumatic events, such as car accidents, Fosamax patients have reported fracturing their femur after experiencing minor falls.
Reports of Fosamax femur fractures have mounted over the years, and, in 2008, the FDA contacted Merck, the maker of Fosamax, regarding this serious side effect. Merck and the FDA worked with the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force to collect more information and evidence regarding this serious side effect. It took Merck more than a year to add the possibility of femur fractures to the warning labels on Fosamax packaging, medication guides, and advertising.
How Patients Should Respond to the Fosamax FDA Femur Warning
Currently, researchers and medical experts are advising that patients should not take Fosamax for longer than 5 years, because the possibility of developing femur fractures (and other serious Fosamax side effects) may increase the longer that this drug is taken. Patients who are currently taking Fosamax should not discontinue use of the medication without the supervision and advice of their physician.
For osteoporosis patients who are considering starting a Fosamax regimen, it’s crucial that:
- Patients disclose their complete medical history to their doctor to ensure that they don’t have a significant risk of developing Fosamax femur fractures. Factors that elevate this risk may include (but are not limited to) having a history of cancer, chemotherapy, radiation, steroid use, dental problems, kidney problems, and/or blood clotting disorders.
- Physicians accurately weigh out the risks and benefits of using Fosamax for each patient. The World Health Organization has developed a software tool (known as FRAXï¿½) that can help doctors assess the likelihood that a given patient will develop a bone fracture.
Regardless of Fosamax FDA femur warnings and the above-mentioned precautions some patients will still sustain femur fractures as a result of taking Fosamax. Injured parties will be entitled to compensation for their injuries and losses by initiating and following through with a defective drug lawsuit against Merck.
If you or a loved one have used Fosamax and suffered a femur fracture, you should contact our defective drug attorneys immediately for a free and confidential case review. You may be entitled to compensation and we can help.