Fosamax and Actonel Side Effects Advisory

Urgent Message for users of Fosamax and Actonel:
Are you suffering symptoms of Osteonecrosis of the Jaw (Dead Jaw)?

WARNING

An increasing number of cases of bisphosphonate related osteonecrosis of the jaw (commonly known as ‘Dead Jaw’) are being reported to the U.S. FDA. These cases are associated with the use of a class of drugs called bisphosphonates, which includes Fosamax (alendronate) and Actonel (risodronate).

Dead Jaw, while rare, is a serious condition that involves the loss or break-down of the jaw bone. In severe cases, it can result in the destruction and removal of the entire jaw. Symptoms of Dead Jaw may include:

• Pain or swelling in the affected jaw
• Infection of the gums
• Loosening of the teeth
• Poor healing of the gums
• Numbness or heavy sensation in the jaw
• A sore with exposed bone in the jaw

Dead Jaw can occur after dental work such as root canals, tooth extractions,or implants. Users of Fosamax, Actonel, or other bisphosphonates are advised to avoid dental work while taking these medications.

The Disease: Osteoporosis

Post-menopausal women may suffer loss of bone mass or density (osteo-porosis). Thin and brittle bones often fracture more easily and doctors advise proactive treatment to slow or prevent the loss of bone in older women.

History of Osteoporosis Treatments

Many doctors regularly prescribed estrogen (hormone replacement therapy) for its bone-protecting qualities  as well as for treating hot flashes and mood swings of menopause. Then a government trial linked the long-term use of HRT to an increased risk of heart disease, stroke and breast cancer.

Fosamax (alendronate), from a class of drugs known as bisphosphonates, was approved as a treatment for osteoporosis in 1995. Millions of women were prescribed Fosamax as an alternative to HRT. Another bisphosphonate, Actonel (risedronate), was approved in 1998.

Cancer Sufferers at Greater Risk

Other bisphosphonates were already in use with cancer patients with bone related complications. Aredia (pamidronate, approved in 1991) and Zometa (zoledronic acid, approved in 2003) are the stronger forms used intravenously to treat cancer patients and patients receiving chemotherapy.

The Side Effect: "Dead Jaw"

In 2003, the connection between bisphosphonates and Dead Jaw was first reported in the Journal of Oral Maxillofacial Surgery by an alert maxillofacial surgeon. He reported the occurrence of Dead Jaw in a large number of hispatients. All had been taking bisphosphonates.

In September 2004, Novartis, the maker of Aredia and Zometa, issued warnings about the potential of Dead Jaw in patients undergoing chemotherapy using bisphosphonates. While most of the initial reports of Dead Jaw were linked to these intravenously administered drugs, there have now been reports of Dead Jaw in users of Fosamax (alendronate) and Actonel (risedronate) – taken in tablet form.

In a post marketing safety review in 2004, the FDA concluded that a continuing safety concern exists for both the oral (tablets) and intravenous (injections) bisphosphonates.

YOU SHOULD…

If you or a loved one have or are currently taking Fosamax (alendronate) or Actonel (risedronate sodium) and have experienced any of the symptoms for Dead Jaw, you should consult your doctor, dentist, or oral surgeon immediately. Under no circumstances should you discontinue taking any medication, without first consulting with your doctor.

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