Fosamax esophageal side effects more serious than seen in clinical trials -- Merck letter to doctors.
Executive Summary
MERCK FOSAMAX ESOPHAGEAL SIDE EFFECTS MORE SEVERE than previously seen in clinical trials, the company told health care professionals in a March 18 letter. The letter states that "since market introduction of the product, some [esophageal] side effects have been of greater severity than we observed in our controlled clinical trials. It is clear from the case reports...that Fosamax can be irritating to the esophagus but that careful adherence to the dosing instructions can reduce the potential for these side effects." Merck sent the letter to 150,000 physicians; the company sent another 50,000 letters to pharmacists March 25.