On a rating scale of 1 to 5 with 1 defined as "Dissatisfied. I would not recommend taking this medication," Fosamax receives an average score of 1.5 on askapatient.
Procter & Gamble's bisphosphonate Actonel also rates a 1.5 and Roche and GSK's Boniva earns a 1.3, the lowest of any drug reviewed on askapatient. (Are you listening Sally Field?)
Bisphosphonates preserve and remineralize bone by turning off bone remodeling-- creation of new bone--that would normally occur. But as early as 2004, Gordon Strewler, MD in the New England Journal of Medicine and Susan M. Ott, MD in the Annals of Internal Medicine warned the remineralized bones could become brittle and fracture-prone and that the drug may actually cause what it is supposed to prevent.
A 2005 article in the Journal of Clinical Endocrinology & Metabolism called "Severely Suppressed Bone Turnover: A Potential Complication Of Alendronate Therapy" warned of patients on Fosamax having "increased susceptibility to, and delayed healing of, nonspinal fractures."
And articles citing "atypical skeletal fragility," "subtrochanteric stress fractures" and "low-energy femoral shaft fractures" on bisphosphonates have appeared in the Journal of Clinical Endocrinology & Metabolism, Journal of Orthopedic Trauma and the journal Injury.
This month, ABC News' Richard Besser, MD, former acting director of the Centers for Disease Control and Prevention (CDC), reports on women's bones breaking from little or no impact on Fosamax and interviews the newly appointed FDA deputy commissioner Joshua Sharfstein, MD.
Like Vioxx, Merck's other block buster whose side effects emerged after it was used/tested on the public, Fosamax was launched a month early thanks to its collegial relationship with the FDA. In fact the FDA waved Fosamax through so quickly--six months after its new drug application--Merck had to send a Dear Physician letter months later warning of esophageal side effects "of greater severity than we observed in our controlled clinical trials." Oops.
And that's not all the "controlled clinical trials"--two 3-year studies--missed.
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