History of Fosamax (Alendronate)

Alendronate, carrying the brand name Fosamax, is a type of bisphosphonate. Bisphosphonates have been used since the middle of the 19th century when they were employed for corrosion prevention and washing powders in the textile, fertilizer and oil industries. About 30 years ago scientists discovered bisphosphonates have the remarkable ability to inhibit the breakdown of bones, experienced by many post-menopausal women.

Fosamax was developed by the giant pharmaceutical company Merck & Co. which gained approval from the Food and Drug Administration in 1995 for the treatment of osteoporosis. Today it is Merck’s second best selling drug with sales in the billions of dollars per year. Their patent on Fosamax extends through the end of 2009, after which it will become available in generic form by rival pharmaceutical companies.

Evidence That Fosamax is Working

Studies show that after three years of use, Fosamax can reduce the risk of hip fractures in patients with a history of vertebral fracture by 51%.

A patient will not feel bisphosphonates working in his or her body, but progress can be monitored with a bone mineral density (BMD) test commonly called a Dexa scan. A Dexa scan is far more accurate than a regular X-ray or CAT scan and uses much less radiation. Increases in bone mass can be seen in as little as three months after therapy has started, but your doctor will recommend the frequency for any ongoing BMD tests.

Side Effects of Fosamax (Alendronate)

Patients who have any of the following conditions should not take Fosamax:

• Disorders of the esophagus connecting the mouth to the stomach
• Are not able to stand or sit upright for 30 minutes
• Have a severe kidney disease
• Have low blood calcium

You should also tell your doctor if you have had stomach or digestive problems or any problems with swallowing.

Many patients take Fosamax with few, if any, problems, while others experience significant side effects. These can include the following:

• Abdominal pain
• Musculoskeletal pain
• Nausea
• Heartburn
• Irritation of the esophagus
• Difficult or painful swallowing
• Chest pain
• Headache
• Constipation and diarrhea

A 2007 study conducted by the University of British Columbia and the Vancouver Health Research Institute found taking Fosamax and other bisphosphonates such as Actonel and Didronel nearly triple the risk of developing bone necrosis, a condition that can lead to disfigurement and incapacitating pain. Bone necrosis is a relatively rare disease diagnosed in approximately 1 in 20,000 people per year. It leads to a permanent loss of blood supply to the bone, and without adequate blood, the bone tissue dies and causes the bone to collapse.

Another concern with taking Fosamax is the risk of developing osteonecrosis of the jaw, also known as jawbone death, after an invasive dental procedure such as having a tooth pulled or implants installed. Most cases of ONJ have been seen in cancer patients who receive treatment intravenously, with about 5 percent of cases linked to those taking bisphosphonates orally. Professors of Oral and Maxillofacial Surgery at the University of Miami published a research study in 2005 entitled "Bisphosphonate-Induced Exposed Bone (Osteonecrosis/Osteopetrosis) of the Jaws: Risk Factors, Recognition, Prevention and Treatment." Their conclusion was that "pre-therapy dental care can reduce the incidence of bisphosphonate-related jaw bone exposure and non-surgical dental procedures can prevent new cases."

However they go on to say, "Given that it has a half life of more than 10 years, the current widespread use of alendronate to prevent or treat early osteoporosis in relatively young women and the likelihood of long term use as well as the ubiquitous presence of dental disease in our society, gives us cause for concern."