Off-label promotions of diabetes meds sometimes nonsensical, watchdog warns FDA

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The nation's leading consumer watchdog is asking the Food and Drug Administration to prohibit direct-to-consumer diabetes drug advertising promoting unapproved off-label benefits like weight and blood pressure reduction.

In one particularly “egregious” example, ads for two drugs promote lowered blood pressure as a potential benefit even though hypotension is also listed among the adverse side effects, Public Citizen asserts in its letter to the FDA filed Tuesday.

The group asked the agency to first warn the companies, then take the unprecedented step of fining manufacturers if they don't remove off-label uses in their advertising and promotions. The five Type 2 drugs are: Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended-release exenatide).

Public Citizen asserts that the ads imply potential weight loss as a benefit, despite disclaimers they are not weight loss drugs and the FDA has not approved them as weight loss medications. It's unclear whether the FDA will take action; the agency issued only 29 warning letters about off-label advertising over the past four years, compared with 111 during the four-year period beginning in 1997, Public Citizen noted.