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Pharmacy and Medications

Fasomax and Back Pain

06/29/2005

Question:

I am looking for information on studies which indicate that longterm use of Fasomax may be linked with back pain, spasms.

Thanks!

Answer:

The following are original research articles that show back pain (musculoskeletal pain) resulting from Fosamax® (alendronate) use.

Devogelaer JP, Broll H, Correa-Rotter R, Cumming DC, Nagant De Deuxchaisnes C, Geusens P, Hosking D, Jaeger P, Kaufman JM, Leite M, Leon J, Liberman U, Menkes CJ, Meunier PJ, Reid I, Rodriguez J, Romanowicz A, Seeman E, Vermeulen A, Hirsch LJ, Lombardi A, Plezia K, Santora AC, Yates AJ, Yuan W. Oral Alendronate Induces Progressive Increases in Bone Mass of the Spine, Hip, and Total Body Over 3 Years in Postmenopausal Women With Osteoporosis. Bone 1996; 18 (2): 141-150.

Siris E, Weinstein RS, Altman R, Conte JM, Favus M, Lombardi A, Lyles K, McIlwain H, Murphy WA, Reda C, Rude R, Seton M, Tiegs R, Thompson D, Tucci JR, Yates AJ, Zimering M. Comparative Study of Alendronate Versus Etidronate for the Treatment of Paget’s Disease of the Bone. Journal of Clinical Endocrinology and Metabolism 1996; 81 (3): 961-967.

Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH, Rodriguez-Prtales J, Downs RW, Dequeker J, Favus M, Seeman E, Recker RR, Capizzi T, Santora AC, Lombardi A, Shah RV, Hirsch LJ, Karpf DB. Effect of Oral Alendronate on Bone Mineral Density and the Incidence of Fractures in Postmenopausal Osteoporosis. The New England Journal of Medicine 1995; 333 (22): 1437-1443.

There is also a large review article on the drug that contains information on this adverse effect.

Sharpe M, Noble S, Spencer CM. Alendronate: An Update of its Use in Osteoporosis. Drugs 2001; 61 (7): 999-1039.

This source contains post-marketing data on this adverse effect in the Australian population.

Anonymous. A gut feeling for alendronate. Australian Adverse Drug Reactions Bulletin 1999; 18 (3).

The package insert also has information on this adverse effect. According to the insert, musculoskeletal (bone, muscle or joint) pain occur at a rate between 0.4 and 4.1 percent of patients taking the medications.

This response was prepared by Sarah Malott, a PharmD Candidate at the University of Cincinnati

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Response by:

University of Cincinnati Robert James Goetz, PharmD, DABAT
Assistant Professor of Pharmacy Practice
Drug and Poison Information Center
Cincinnati Children’s Hospital Medical Center
University of Cincinnati