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FOSAMAX INFORMATION
Fosamax Linked to Bone Death in Jaw
Fosamax, used by nearly 10 million men and women to help prevent or treat bone loss or osteoporosis, has allegedly been linked to 2,400 incidents of jaw bone decay or Osteonecrosis of the jaw since 2001. An additional 120 people taking these drugs in pill form have claimed to have such debilitating pain that they have become bedridden or in need of walkers, crutches or wheelchairs. Moreover, as much as 90 percent of drug side effects may never have been reported to the FDA, meaning the total number of people suffering from ailments because of Fosamax may be much higher.
Osteonecrosis or “dead jaw” has been linked to patients using both injectable and oral bisphosphonates such as Fosamax, a review from FDA’s Office of Drug Safety states.
Fosamax is the brand name for the drug Alendronate. It belongs to a class of drugs know as bisphosphonates and is approved by the FDA for the treatment of Osteoporosis, or thinning of the bones. Bisphosphonate drugs have been used since 1995 to strengthen bone in women who are losing bone density. The have also been used for nearly 15 years in men and women who have cancer. Other bisphosphonates include Actonel, Boniva, Bonefos, Didronel, Aredia, Skelid and Zometa.
A connection between bisphosphonates such as Fosamax, and Osteonecrosis of the jaw (ONJ) was discovered in 2004. The findings were published in the Journal of Oral and Maxillofacial Surgeons and showed the side effects of Fosamax may include ONJ, a condition commonly called “dead jaw.”
Osteonecrosis of the jaw is a disease in which bone tissue in the jaw does not heal after minor traumas. Dental extractions that cause bone to become exposed can lead to fractures and infections often requiring long-term antibiotic therapy and surgery to remove the dead and dying bone tissue. Some researchers and pharmaceutical experts state that prevention and early treatment of patient using Fosamax is critical in the preservation of a healthy jaw bone. Individuals using Fosamax and other bisphosphonates should try to avoid tooth extractions and other major dental work while taking these medications.
Symptoms of “dead jaw” include irregular sore with exposed bone, pain or swelling in the infected jaw, infection, possibly with pus, altered sensation - numbness or a heavy sensation.
The highest risk factors for ONJ are:
1) taking bisphosphonates like Fosamax, especially in IV form
2) concurrent use of steroids
3) previous history of cancer, osteoporosis or Paget's disease
4) traumatic dental procedure, such as tooth extraction or dental implants.
FOSAMAX Q & A
What is Fosamax?
Fosamax is for:
- The treatment or prevention of osteoporosis (thinning of bone) in women after menopause. It reduces the chance of having a hip or spinal fracture.
- Treatment to increase bone mass in men with osteoporosis.
- The treatment of osteoporosis in both men and women receiving corticosteroid medications (for example, prednisone).
How does Fosamax work?
Fosamax works by:
- Reducing the activity of the cells that cause bone loss.
- Decreasing the faster rate of bone loss that occurs after menopause or with use of corticosteroid medications.
- Increasing the amount of bone in most patients.
These effects are seen as soon as three months after therapy with Fosamax has begun. These effects continue as long as you keep taking Fosamax. The density of bone is maintained or increased and the bone is less likely to fracture.
Who should not take Fosamax?
Patients with:
- Certain disorders of the esophagus (the tube that connects your mouth with your stomach).
- Inability to stand or sit upright for at least 30 minutes.
- Low levels of calcium in their blood.
- Severe kidney disease.
- Allergy to Fosamax.
Patients who are:
What are the possible side effects of Fosamax?
Some patients may develop severe digestive reactions including irritation, inflammation or ulceration (occasionally severe and/or with bleeding) of the esophagus (the tube that connects your mouth with your stomach). These reactions can cause chest pain, heartburn or difficulty or pain upon swallowing. This may occur especially if patients do not drink a full glass of water with Fosamax and/or if they lie down in less than 30 minutes &r before their first food of the day. Esophageal reactions may worsen if patients continue to take Fosamax after developing symptoms suggesting irritation of the esophagus.
Like all prescription drugs, Fosamax may cause side effects. Side effects usually have been mild. They generally have not caused patients to stop taking Fosamax. Some patients treated with Fosamax experienced abdominal (stomach) pain. This is the most commonly reported side effect. Less frequently
reported side effects are:
Nausea, heartburn, irritation or pain of the esophagus (the tube that connects your mouth with your stomach), vomiting, difficulty swallowing, a full or bloated feeling in the stomach, constipation, diarrhea, black and/or bloody stools, stomach or other peptic ulcers (some severe), and gas.
Bone, muscle or joint pain, headache, or an altered sense of taste were also experienced by some patients. Rarely, a rash (occasionally made worse by sunlight) or eye pain have occurred. Allergic reactions such as hives or, rarely, swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing have also been reported. Mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth. Anytime you have a medical problem you think may be related to Fosamax, talk to your doctor.
Source
Issued January 2001
MERCK&CO., INC.
Whitehouse Station, NJ 08889, USA
If you suffer from dead jaw, Osteonecrosis or bone death as a result of taking Fosamax you should contact an attorney. Please fill out the form below and your submission will be forwarded to an experienced attorney.
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