What is Fosamax?

Fosamax, also known as Alendronate, belongs to a class of drugs called bisphosphonates, which are used to treat and prevent osteoporosis (a serious disorder where the bones weaken and break easily, usually in post-menopausal women) and Paget’s disease. They are also used to treat some bone cancers. Bisphosphonates work by preventing the breakdown of bone and increasing bone density, or thickness.
What are the Dangers of taking Fosamax?
Since at least 2003, there have been reports of a possible link between bisphosphonates and a rare, but serious disorder called osteonecrosis (ONJ), or “dead jaw”. This devastating condition has primarily been associated with active dental disease or dental work, such as a tooth extraction. Osteonecrosis affects both the mandible and maxilla jaw bones, causing necrotic bone or bone marrow that has been starved by low blood flow. To repair the jaw bone damage, it may be necessary to undergo a painful surgery to remove the dying bone tissue. Side effects may include jaw pain, numbness, loss of teeth and infection. Even mild cases, osteonecrosis can create a bone marrow environment that is conducive to bacterial infections.

An article in the May 3, 2007 issue of The New England Journal of Medicine also described increased rates of serious atrial fibrillation in older women treated with bisphosphonates, Reclast and Fosamax.

Esophageal ulcers and erosion, occasionally with bleeding and rarely followed by esophageal perforation have also been reported. In some cases these have been severe and required hospitalization. This condition was usually found in patients who did not remain upright for the necessary length of time or did not drink the required water after taking the medication.

What are the Side Effects?

Tell your doctor if any of these symptoms are severe or do not resolve:
 mild heartburn or stomach upset
 constipation, gas, bloating or diarrhea
 mild back pain or joint pain
 flu-like symptoms

Call your doctor immediately if you experience any less common, but more severe side effects:
 chest pain
 difficult or painful swallowing
 bloody vomit or vomit that looks like coffee grounds
 pain or burning in the back, under the ribs
 severe joint, bone or muscle pain
 jaw pain, numbness or swelling
 rash or hives

Signs of possible osteonecrosis, or dead-jaw include:

 loosening of teeth
 pain, swelling, infection or poor healing of gums
 the feeling of heaviness in the jaw, jaw numbness
 loss of jaw bone

FDA Warnings:

On September 24, 2004 the FDA issued a warning to healthcare professionals containing information about bisphosphonates and the dangers and risks of osteonecrosis of the jaw. There has not been a recall and the drugs have not been withdrawn from the market.

The FDA is seeking additional data to allow for an in-depth evaluation of the atrial fibrillation issue for the entire class of bisphosphonates. It may take up to 12 months to complete the evaluation at which time FDA will communicate the conclusions and any resulting recommendations to the public.

James R. Keller
Connect with me
Partner at Keller & Keller