FDA Warns Lilly Over Axid Claims

Eli Lilly's promotion to managed care customers of its Axid (nizatidine) H2 antagonist for gastro-esophageal reflux diseases is misleading, according to the US Food and Drug Administration's Division of Drug Marketing, Advertising and Communications. In a warning letter to the company, the FDA cites several violations, including claims that Axid is the drug of choice for GERD compared to other H2 antagonists and Astra/Merck's omeprazole.

Lilly has been promoting Axid to its managed care customers as a second-line alternative to cimetidine for ulcers, but as a first-line therapy for GERD, according to the Pink Sheet. The ads claim that Axid is "the healing choice before omeprazole," and has advantages over cimetidine in terms of dosing and utility in healing rather than treating symptoms. The FDA disputes both these claims in the letter, and refers to other violations including unapproved indications and doses and selective citation of results from studies.