MONTREAL – A non-profit Montreal-based consumer group wants to launch a class-action suit against pharmaceutical giant Merck Frosst for failing to disclose side effects connected with Fosamax, an osteoporosis drug.
Worried about fractures and bone damage associated with long-term use of the medication, the group is warning consumers, doctors and government health agencies of potential risks, said Jacinthe Lauzon of Option-Consommateurs.
Fosamax (alendronate) has been marketed largely to healthy women in Canada as a drug to prevent bone loss.
An estimated 3,000 Quebec women take the drug. Last year, RAMQ, the Quebec health insurance board saw 1.5 million prescriptions filled at a cost of $26 million, Lauzon said.
Since the group filed its class action demand in 2007 several disturbing international studies have come to light, Lauzon said.
Fosamax is in a class of medications called bisphosphonates. But studies suggest that the drug designed to strengthen bones is not effective in preventing bone degeneration and fractures, and in some cases may lead to weak, brittle bones that can break spontaneously.
The drug is also associated with rare side-effects, including osteonecrosis, or Fosamax dead-jaw, a painful condition that can cause serious health consequences. According to various studies, the rate of such side effects is about one in 1,000 users, Lauzon said.
Lawsuits launched in the United States on behalf of patients with jaw damage following dental work and femur bone fractures contend that Merck Frosst may have shown distorted data results based on too few studies when seeking approval for Fosamax for prevention purposes.
As early as 2006 a study by Health Canada showed the drug did not significantly reduce the risk of fractures except in vertebrae bones, Lauzon said.
A longitudinal Italian study of 862 Fosamax users showed fractures at a rate of nearly 10 per cent a year, higher than the company’s clinical trials. The ICARO study published in 2008 suggests the benefits of the bone drug have been overstated.
Option-Consommateurs wants Health Canada to re-evaluate Fosamax safety and efficacy, Lauzon said. Drug companies have to be up front with consumers about possible risks, she added.
Reached late afternoon Monday, Vincent Lamoureux, corporate spokesperson for Merck Frosst Canada, said the company would not be able to comment until the following day.
The class action suit demand is expected to be heard in the fall. For information on the suit go to www.option-consommateurs.org
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