Drug manufacturer Glaxo is in trouble with the US Food and Drug Administration over its advertising of Zantac (ranitidine), a treatment for peptic ulcers.
The FDA cites a total of eight violations of the Federal, Food, Drug and Cosmetic Act, including unfairly knocking the competition, and promoting the drug’s use for preventing stress ulcer, for which it is not approved.
Glaxo is likely to have to join another anti ulcer drug manufacturer, Marion Merrell Dow, in the ignominy of having to issue “Dear Doctor” letters correcting its earlier false claims.
Marion Merrell ran into strikingly similar problems over its advertising for Carafate (sucralfate).
It is currently having to run a series of ads in the medical press correcting its “false and/or misleading” earlier claims:
“Carafate has not been proven superior to histamine H2 receptor antagonists. . .Carafate has not been proven superior in effectiveness to other anti ulcer medications. . .Carafate has not been proven to offer equal duodenal ulcer healing rates. . . .”