Fosamax
What is the effect of taking Fosamax?
The drug Fosamax has been linked to an increased risk of osteonecrosis of the jaw, a devastating illness that causes the jaw bone to die resulting in loss of teeth, increased infection and exposed bone.
A number of studies in the United States have shown an increased risk of osteonecrosis in people who have taken Fosamax, which is prescribed for osteoporosis or as part of certain cancer regimens.
What is Fosamax?
Fosamax belongs to a class of drugs known as bisphosphonates and has been on the market since 1995. Fosamax is prescribed to treat Osteoporosis, a disease that primarily affects postmenopausal women and elderly men, however, it can strike any person at any time. Fosamax is taken orally in either pill form or a fluid suspension that must be taken on an empty stomach first thing in the morning.
Osteoporosis
Fosamax is prescribed mainly to treat osteoporosis, which literally means porous bones. The bones in our skeleton are made of a thick outer shell and a strong inner mesh filled with collagen (protein), calcium salts and other minerals. The inside looks like honeycomb, with blood vessels and bone marrow in the spaces between bone.
Osteoporosis occurs when the holes between bone become bigger, making it fragile and liable to break easily. Osteoporosis can affects the whole skeleton but it most commonly causes breaks (fractures) to bones in the wrist, spine and hip. However, osteoporosis causes no pain or other symptoms until a bone breaks.
Osteonecrosis
Recent studies have implicated Fosamax in the serious necrosis of the jaw and other bones, a condition known as osteonecrosis (ONJ) - also called "bone death."
Osteonecrosis of the jaws is a severe bone disease that affects the jaws. Jaw bone (osteo-) damage and death (-necrosis) occurs as a result of reduced local blood supply (ischaemic). The condition is thus included in the general category of ischaemic or avascular osteonecrosis (which literally means "dead bone from poor blood flow").
Osteonecrosis is a very rare disease. It typically begins with loosening of teeth, or lesions on the gum, and can progress to the point where whole sections of the necrotic bone need to be removed, rendering the patient unable to chew solid food. If osteonecrosis is not treated, it can cause septicaemia in the blood and result in death.
Osteonecrosis is rare, but causes of the disease include:
- Cancer
- Radiation Therapy
- Chemotherapy
Fosamax linked to Osteonecrosis
In the past, doctors and dentists paid significant attention to the risk of osteonecrosis of the jaw caused by chemotherapy. However, in August 2004, the United States Food and Drug Administration (FDA) issued a report based upon its review of Fosamax-associated Osteonecrosis of the Jaw (ONJ) and indicated that the risk was not solely due to chemotherapy. The FDA observed that the risk of ONJ likely extended to oral bisphosphonates, chiefly Fosamax, and the manufacturer (Merck Pharmaceuticals) should advise prescribers of the risk.
At about the same time case reports began appearing in oral surgery journals in which the authors concluded that Fosamax was a risk factor for ONJ.
How does Fosamax cause Osteonecrosis?
The process by which bisphosphonates (the family of drugs to which Fosamax belongs) work against osteoporosis can inadvertently cause osteonecrosis. Bisphosphonates like Fosamax work by preventing osteoclasts (bone material) from being removed. However, normal osteoclasis is vital to bone turnover and viability. The inhibition of this process can result on Osteonecrosis.
Regulatory response by US FDA
In August 2004, the United States Food and Drug Administration issued its Postmarketing Safety Review on about four bisphosphonate drugs used to treat osteoporosis: Fosamax, Zometa, Aredia, and Actonel, The FDA report concluded that warning language about adverse events involving osteonecrosis should be added to the drugs' labels.
On September 24, 2005, Novartis issued a "Dear Doctor" letter regarding Zometa and Aredia, indicating that patients on injected bisphosphonate therapy should avoid invasive dental procedures, and that a dental examination should occur before initiating intravenous bisphosphonate therapy. The letter quoted the new precaution to be placed in the product label in August 2004.
Fosamax, Zometa, Aredia, and Actonel are all licensed and available in Ireland.
Making a claim
For futher information on Pharmaceutical Litigation, please contact Malcomson Law by calling 01 8744422 or by filling out an Online Enquiry Form. A solicitor who specialises in this area will contact you to advise you of your legal rights and entitlements.