MSD responds to Fosamax adverse effect claims

Merck, Sharp and Dohme (MSD) has responded to claims made last week in the New England Journal of Medicine regarding the incidence of adverse events in patients administered with Fosamax (alendronate sodium).

The company reports that the five-year fracture intervention trial (Fit) investigating the effect of the compound on the incidence of osteoporotic fracture was the largest clinical study in this area.

According to the results of this trial, patients receiving Fosamax and placebo exhibited a similar risk of atrial fibrilliation adverse events, while a numerical increase in the risk of serious events of this type in patients administered Fosamax is not significant.

“Atrial fibrillation adverse experiences were collected throughout the duration of Fit and verified by an independent physician who was blinded to patient treatment,” the company reports.

It adds that the trial was monitored by a data safety monitoring board that did not seek to stop the study for any safety concerns.

MSD also notes that the increase of serious adverse experiences of atrial fibrillation in patients treated with zoledronic acid was reported last September at the annual meeting of the American Society for Bone and Mineral Research.

In May 2006, CNN reported that a “small” number of lawsuits could potentially be brought against MSD relating to claims that treatment with Fosamax had resulted in osteonecrosis in some patients.