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Consumer advocacy group Public Citizen said this week that the Food and Drug Administration (FDA) must stop direct-to-consumer advertisements that market several “dangerous” diabetes medications for weight loss or blood pressure reduction.
Consumer advocacy group Public Citizen said this week that FDA must stop direct-to-consumer advertisements that market several “dangerous” diabetes medications for weight loss or blood pressure reduction.
The drugs, Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended-release exenatide), are being marketed for uses that have not been approved by FDA, according to Public Citizen’s letter to the agency.
“The FDA has never deemed any of the five medications safe or effective for either use, and low blood pressure is a major side effect of the two drugs (Farxiga and Invokana) promoted for this use,” said Public Citizen said in a statement.
By inflating the drugs’ perceived benefits, the advertisements dangerously skew the risk-benefit calculations made by physicians and patients toward deciding to initiate or continue these therapies, according to Public Citizen. “This is especially likely to occur with a weight-loss claim targeted at overweight and obese type 2 diabetics struggling with both their disease and their weight,” the statement said.
Public Citizen is calling on FDA to issue warning letters requiring the manufacturers to withdraw these and any other advertisements containing similar off-label promotional statements.
FDA has never fined a pharmaceutical company for unlawfully misleading drug ads, despite having the authority to do so since the 2007, according to Public Citizen. “Therefore, to more effectively deter future ads that violate FDA rules, Public Citizen also is calling on the agency to fine the companies involved in the off-label marketing of the five diabetes drugs,” the group stated.