Fosamax
Consumer Alert: Merck is at it again, osteoporosis drug, Fosamax, is associated with Dead Jaw (Jaw Necrosis)
Merck Pharmaceuticals, the manufacturer of the osteoporosis drug, Fosamax, (alendronate), has been on the market for ten years, generating over 3 billion dollars in revenue in 2005, making it Merck’s second best selling drug [i]. It is prescribed for the prevention of bone loss which is known as osteoporosis.
In recent studies, an association was made between biphosphonates (drugs used to control or improve bone density) and jaw necrosis, “jaw bone death”; an interference of blood supply to the bone, which results in the deterioration of the jaw bone. Jaw necrosis is not the only debilitating side effect [ii]. Others include:
Espohagitis, upper gastrointestinal mucus, esophageal ulcers, esophageal erosions, esophageal stricture or perforation, uncontrollable heartburn, abdominal pain, acid regurgitation, bone and joint pain, constipation, diarrhea, gas, indigestion, muscle pain, nausea, skin rash, difficulty swallowing, bloated feeling, dyspepsia, gastritis, flatulence, and *jaw necrosis [iii].
* Jaw Necrosis is dead bone of the jaw [iii].
The Department of Health and Human Services says Merck’s marketing and promotional materials claimed “Menopause is the single most important cause of Osteoporosis” indicating menopausal and post-menopausal women should take the drug to prevent spine and hip bone fractures caused by osteoporosis [iv].
However, Merck misled consumers by exaggerating the amount of people that should take the drug [iv]. They claimed all women would develop osteoporosis because of menopause [iv]. Yet, menopause alone does not cause osteoporosis.
Osteoporosis is caused by low calcium intake, acid/alkaline imbalance, malnutrition, being underweight, history of dieting, caffeine, nutritional deficiencies, inadequate peak bone mass, lack of exercise, over exercise, poor bone repair, high fait diets, junk food, sugar, stress, weak adrenals, weak digestion, tobacco, endocrine imbalance, irregular menstruation, onset of early menopause, eating disorders (especially anorexia nervosa), heavy alcohol consumption, kidney disease, certain genetic disorders, thyroid problems, diabetes, chronic liver disease, and low or no vitamin D in daily diet [v].
The Associated Press states that in April 2006 a lawsuit was filed in the US District Court in Ft. Myers, Florida stating the US Food and Drug Administration told Merck to include a warning label on Fosamax in August 2004 [vi]. This label indicated the risks and long term side effects while taking the drug. However, Merck claimed they didn’t receive a request from the FDA to update the label until January 2005. Merck waited another six months before updating the warning label in July 2005 [vi].
Have you or a loved one been taking Fosamax and experienced any of the above side effects? Contact Us.
- Merck Financial Sheet 2005. (2005). Merck News. http://www.merck.com/newsroom/press_releases/financial/2005_0421.html
- Susan Ott (2004). Osteoporosis and Bone Physiology: Osteonecrosis the Jaw. Dept of Medicine: University of Washington: Seattle, Washington http://courses.washington.edu/bonephys/opjawON.html
- Merck & Co., Inc. (2000). Fosamax Tablets and Oral Solution Description Sheet. Whitehouse Station, NJ. http://www.fosamax.com/fosamax/shared/documents/english/pi.pdf
- Department of Health & Human Services: US Food and Drug Administration (1997). Fosamax Aledronate Sodium Tablets: Letter to Ellen Westirck, Senior Director of Legal/Medical Office, Merck & Co.
- Susan Ott (2004). Osteoporosis and Bone Physiology. Dept of Medicine: University of Washington: Seattle, Washington http://courses.washington.edu/bonephys/opdiagnosis.html
- Theresa Agovino. AP Business Writer (4/12/2006). Lawsuit Alleges Merck Negligent. Associated Press: NY, NY