A Canadian consumer group is considering filing a class-action complaint against Merck Frosst for failing to disclose side effects connected with the bisphosphonate drug Fosamax, according to an article in the Montreal Gazette.
Bisphosphonate treatment for osteoporosis has been associated with a risk of developing bisphosphonate-related osteonecrosis of the jaw (BONJ).
Option-Consommateurs originally filed a class-action demand in 2007. Since then, "several disturbing studies have come to light," Jacinthe Lauzon, communications advisor for Option-Consommateurs, told the Gazette. Option-Consommateurs wants Health Canada to re-evaluate the safety and efficacy of Fosamax, Lauzon said. For example, findings from the Incidence and Characterization of Inadequate Clinical Responders in Osteoporosis (ICARO) study published in 2008 suggested the benefits of the bone drug have been overstated (Osteoporosis International, August 2008, Vol. 19:8, pp. 1219-1223).
In addition, numerous lawsuits have been filed in the U.S. against Merck on behalf of patients claiming they developed BONJ after using Fosamax. Those suits contend that Merck may have shown distorted data results based on too few studies when seeking regulatory clearance for Fosamax, according to the Gazette.
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