Fosamax side effects and benefits, safety, danger, lawsuit, osteoporosis benefit and bone health, medical uses, dosage
August 17 2015 by
Ray Sahelian, M.D.


Fosamax (alendronate sodium as generic) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Fosamax is made by Merck and is part of the bisphosphonate family of osteoporosis drugs that include Procter & Gamble Co's Actonel and Roche Holding AG's Boniva. The drugs are designed to prevent bone fractures and help offset bone loss associated with menopause.


Side effects
Gastrointestinal Events Among Patients Initiating Osteoporosis Therapy: A Retrospective Administrative Claims Database Analysis. ur purpose was to characterize the occurrence of gastrointestinal (GI) events among women on oral bisphosphonate therapy. This was a retrospective cohort study that used a United States (US) claims database. The study period was from January 1, 2000, to December 31, 2011. The index date was the date of the first oral bisphosphonate (alendronate, ibandronate, or risedronate) prescription. Approximately one fourth of US women on bisphosphonate therapy experienced GI events within the year after initiation of therapy, and one half of US women with a previous GI event had another event while taking bisphosphonates. Clin Ther. 2015.


TV ads
An ad on TV says : Let's not wait till you break another bone. Bone loss can be reversed. Fosamax plus D helps reverse osteoporosis and bone loss. Fosamax helps prevent hip and spine fracture. You should not use Fosamax if you have certain disorders of the esophagus, you have to be able to stand or sit up right, if you have severe kidney disease or low blood calcium, you should not take Fosamax plus D. Stop taking Fosamax if you have heartburn or swallowing becomes difficult or painful, or if you have chest pain.


A Manhattan federal judge refused in January 2010 to dismiss a lawsuit alleging that Merck & Co Inc's osteoporosis drug Fosamax caused jaw damage to an Indiana woman during the nearly eight years she took the pill. U.S. District Judge John Keenan described the case involving plaintiff Louise Maley, 69, as one of the "bellwether" trials in nationwide litigation over Fosamax, which has spawned close to 900 lawsuits.

Generic Fosomax
Feb 2008 - FDA has approved the first generic versions of Fosamax (alendronate sodium tablets), used to treat osteoporosis, a condition that causes thinning and weakening of bones. Teva Pharmaceuticals USA was approved to manufacture alendronate sodium tablets in three once-daily dosing strengths (5 milligrams, 10 milligrams, and 40 milligrams) and two once-weekly strengths (35 milligrams and 70 milligrams). Barr Laboratories, Inc., was approved to manufacture a 70-milligram, once-weekly, dose of the drug.

Fosamax or Actonel - contradictory research - depends who is funding the study

Postmenopausal women with the bone-thinning condition osteoporosis who are treated with Fosamax have greater gains in bone mineral density (BMD) than women treated with risedronate (Actonel),. Dr. Sydney Bonnick, of the Clinical Research Center of North Texas, Denton, and colleagues conducted a 1-year extension of the Fosamax Actonel Comparison Trial (FACT) to compare outcomes after 2 years of treatment. Of the 1053 women who completed the first year, 833 women with low BMD were included in the extension study. The women continued on their assigned treatment -- either 70 milligrams of Fosamax once weekly or 35 mg of risedronate once weekly -- for another year. While both drugs resulted in increases for all BMD measurements, Fosamax -treated patients had greater increases after 24 months. Both treatments significantly reduced all biomarkers of bone turnover, but the differences between the groups favored Fosamax, according to the investigators. No significant differences were observed between the groups in terms of adverse events, including gastrointestinal upsets. Journal of Clinical Endocrinology and Metabolism, July 2006.


The results of a new study suggest that Actonel (risedronate) provides greater fracture protection in the first year of therapy than does Fosamax (alendronate). Among 33,830 women, 65 years of age or older, taking once-weekly Actonel or Fosamax for the first time, researchers found that the 12,215 women on Actonel had significantly lower rates of hip and nonvertebral fractures during the first year of therapy than the 21,615 women on Fosamax. The low fracture rate seen with Actonel is "consistent with results from randomized clinical trials," Dr. Pierre Delmas from Universite Claude Bernard, Lyon, France, notes in a statement accompanying the study, published in the journal Osteoporosis International. During 12 months of observation after the start of therapy, there were 507 nonvertebral fractures and 109 hip fractures. During the first 3 months of therapy, the incidence of fracture was similar between the Actonel and Fosamax groups. After 6 months of therapy, the Actonel group had a 46-percent lower incidence of hip fracture and a 19-percent lower incidence of nonvertebral fracture compared with the Fosamax group. After 12 months of therapy, the Actonel group had a 43-percent lower incidence of hip fracture and an 18-percent lower incidence of nonvertebral fracture relative to the Fosamax group. Four of the authors of this report have received consulting fees, lecture fees, or research grants from The Alliance for Better Bone Health (Procter and Gamble Pharmaceuticals and Sanofi-Aventis, while the fifth is an employee of Procter and Gamble.


Taking a break from Fosamax
Most postmenopausal women who stop taking the osteoporosis drug Fosamax after five years do not increase their risk for nonvertebral fractures over the next five years. Women who are at a lower risk for fractures or don't have previous fractures should take breaks from the use of Fosamax. A Fosamax drug holiday for a year or two after several years of use would reduce Fosamax side effects and still not increase the risk for bone fractures. Fosamax (alendronate) belongs to the class of medications known as bisphosphonates.


Hyperparathyroidism and Fosamaz
Elderly women about to begin taking Fosamax for preventing the brittle bone disease osteoporosis should have their parathyroid hormone level checked first. Low levels of vitamin D can lead to excessive levels of parathyroid hormone, a condition known as secondary hyperparathyroidism. Among a group of women taking Fosamax to treat osteoporosis, those with hyperparathyroidism showed less increase in bone mineral density than those with normal parathyroid hormone levels. Perhaps vitamin D supplementation could be helpful.


Use with Chinese herbs
Curr Drug Targets. 2013 Dec. Beneficial effects of traditional Chinese medicine on the treatment of osteoporosis on ovariectomised rat models. Osteoporosis is a metabolic bone disorder that affects both men and women worldwide. It causes low bone mass and therefore increases bone susceptibility to fracture when bone undergoes a minor trauma. Lack of estrogen is the principal cause of osteoporosis. Estrogen, calcium, calcitonin, vitamin D and several antioxidants help in the prevention of osteoporosis. In order to effectively treat osteoporosis, there has been an extended research on the biological activities of traditional medicines since synthetic medicines possess several side effects that reduce their efficacy. Therefore, there is a need to develop new treatment alternatives for osteoporosis. This review centres on the scientific researches carried out on the evaluation of Chinese traditional medicines in the treatment of osteoporosis. Various plants like Achyranthes bidentata, Davallia formosana, polygonatum sibiricum, Cibotium barometz, Er-Zhi-Wan, Curculigo orchioides and a combined treatment of Hachimi-jio-gan (Ba-Wei-Di-Huang-Wan) with alendronate proved active in preventing post-menopausal osteoporosis.



Q. I read your newsletter, that stated Boniva and/or Fosamax may cause jaw necrosis. Do you have any research documentation regarding Boniva or Fosamax causing jaw death in approximately 10% of the poplution? My doctor would more scientific data supporting this claim.

Q. Has there been any link between kidney stones and Fosamax usage?
   A. We have not seen much human research in regards to kidney stones and Fosamax.

Fosamax - Alendronate inhibits urinary calcium microlith formation in a three-dimensional culture model.
Urol Res. 2004.
Osteoporosis is associated with the pathogenesis of urinary stone formation. Urinary stones are similar to bone diseases such as osteoporosis and bone metabolism in terms of pathogenesis. Bisphosphonates are potent inhibitors of bone resorption, and are used in the management of bone disease. Furthermore, bisphosphonates have a strong affinity for calcium, and a reported inhibitory effect on calcium oxalate crystallization in vitro. Thus, bisphosphonates might also inhibit urinary stone formation. Madin-Darby canine kidney (MDCK) cells form calcium phosphate microliths at the basolateral side in vitro. We investigated the inhibitory effects of new generation bisphosphonates (Fosamax and incadronate) on calcium phosphate microlith formation and on the expression of osteopontin, which is an important urinary stone matrix. The present findings show that Fosamax inhibits calcium stone formation, suggesting that it is effective in the prevention of urolithiasis.


Q. I have gastritis, reflux, esophagitis and irritable bowel. My esophagitis was caused by alendronate Fosamax, which I received through my blood, 90 ml to stay 6 months in my body.


Q. I am taking Fosamax Plus D but would like to know if I can take just Fosamax and vitamin D supplement on the side. Essentially, I would like to know what exactly is the difference between Fosamax Plus D and plain Fosamax (both of the 70mg strength).
   A. Fosamax Plus D 70 mg / 2800 IU vitamin D. Apparently Fosamax plus D has 2800 units of vitamin D.


Please help me with a comment I just received from a patient who recently discontinued Fosamax (8 years). Her daughter-in-law is a dentist and told my patient that she would die if she ever broke a bone while on Fosamax. This is the first time I have ever heard such a comment and was curious as to any information you might have which would stem a statement such as this.
    I have not heard of any such reports regarding death from fracture while using this medication.

Thanks for the goldmine of info on your site! What is your take on the possible side effects revealed by ABC news of the Actonel and Fosamax types of drugs?
    I did not see the ABC news account, but I will update this site as more info is published.