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Serious side effects have been reported from long-term use of Fosamax (Alendronate) and other drugs used to treat osteoporosis.
The U.S. Food and Drug Administration has ordered manufacturers of these drugs, known as bisphosphonates, to come up with new recommendations about how long patients should take the drugs and whether “drug holidays” would benefit long-terms users. A growing number of experts have said the drugs should be taken no longer than five years.
Drug makers did not study the drug well enough before offering it for sale, and also have failed to adequately warn users about its risks. If you or a loved one took Fosamax and suffered severe, permanent injury, you have the right to hold the manufacturer responsible. Although a lawsuit cannot ease the pain or loss of a loved one, it can help compensate for losses in income, quality of life and suffering. An experienced Fosamax attorney with Janet, Jenner & Suggs will review your situation and advise you. Consultations are offered free of charge.
Consumer Alert
The FDA has announced that Fosamax has been linked to serious bone deterioration, particularly in the jaw, hip, shoulder, knee and femur (upper thigh bone). Symptoms may occur days, months or even years after taking the drug. Other drugs that fall into the class of bisphosphonates that also have been linked to serious side effects include Fosamax Plus D, Actonel, Actonel with calcium, Boniva, Atelvia, and Reclast.
Users of bisphosphonates also have been shown to have an increased risk of Aseptic Osteonecrosis (AON), also referred to as avascular necrosis, aseptic necrosis or osteonecrosis. If you are diagnosed with any of these conditions, contact an experienced attorney with Janet, Janet & Suggs.
Osteonecrosis of the Jaw (ONJ), Dead Jaw or Bis-Phossy Jaw
Osteonecrosis of the jaw is a rare but painful and potentially disfiguring condition that frequently arises after a dental procedure, such as a tooth extraction. The gums fail to heal, leading to exposed jawbone and infection. This may require long-term antibiotic treatment or surgery to remove dead or decayed portions of the jawbone.
Symptoms of jaw necrosis could include:
• Jaw pain
• Gum infection, swelling or drainage
• Loose teeth or toothaches
• Exposed bone inside the mouth
• Jaw numbness or feeling of heaviness in the jaw
Osteonecrosis (bone death) of the hip is the most common form of joint necrosis. It is caused by decreased blood flow to the bone, causing it to weaken and die. This permanent hipbone decay causes severe pain, reduced mobility and bone decay to the point that they may collapse. A form of hipbone decay caused “avascular necrosis” can occur naturally. However, some studies have suggested that Fosamax could increase the risk of developing this condition.
These conditions can come on slowly with mild symptoms, or quickly with severe symptoms. Symptoms of osteonecrosis of the hip include:
• Joint pain in the hip
• Limited mobility
• Gradual increase in pain levels
• Loss of hip function
Osteonecrosis of the knee is a painful and debilitating condition involving permanent decay of the bones that support the knee joint. Symptoms may vary in patients due to the progressive nature of the condition. For some, the bone decay develops slowly, beginning with mild joint pain, but for others the process is more rapid.
Avascular necrosis is caused by decreased blood flow to the knee, which causes the bone to weaken and die. It is associated with extreme pain and a loss of mobility, usually leaving the knee permanently damaged. Knee problems associated with avascular necrosis could include:
• Joint pain in the knee
• Limited mobility
• Gradual increase in pain levels
• Loss of knee function
Osteonecrosis of the shoulder is a condition associated with the decay of bone in the shoulder joint, caused by a restriction of blood flow. The condition can cause extreme pain and loss of function in the shoulder. The speed at which shoulder deteriorates can vary from one person to the next, but it often affects use of the arm.
Possible symptoms of shoulder necrosis could include:
• Joint pain in the shoulder
• Limited mobility
• Gradual increase in pain levels
• Loss of shoulder or arm function
In October 2010, the U.S. Food and Drug Administration (FDA) warned that bisphosphonates used to treat osteoporosis have been linked to two rare types of thigh fractures, known as subtrochanteric and diaphyseal femur fractures.
Typical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, the FDA said in its alert that these unusual femur fractures have been mainly reported in patients taking bisphosphonates. According to the FDA, these atypical fractures may be related to long-term term use of these drugs.
The FDA has ordered drug manufacturers to provide users with information about the possible association between the unusual thigh fractures and bisphosphonates in the Warnings and Precautions section of the drugs’ labels.
In addition, Fosamax and other bisphosphonates have been linked to the following:
• Cancer of the esophagus (part of the throat)
• Atrial fibrillation (chronic irregular heart beat)
• Severe muscle and joint pain
If you or a loved one were treated with bisphosphonates and suffered any of the above injuries, you may have valuable legal rights. Please fill out our online form, or call us toll-free 1-877-My-Advocates (1-877-692-3862) to discuss your case with one of our pharmaceutical injury lawyers today.