Consumer advocacy group Public Citizen is urging the FDA to put a halt to the direct-to-consumer advertisements that market several “dangerous” diabetes medications, including Invokana, for weight loss or blood pressure reduction.

The diabetes medications, including drugs sold under the names Farxiga, Jardiance, and Invokana, 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 the FDA to issue warning letters requiring the drug manufacturers to withdraw these and any other advertisements containing similar off-label promotional statements involving Invokana and other diabetes medications.

Consumer Advocates Claim Invokana Risks Outweigh Benefits

Invokana (canagliflozin) is the first member of a new family of diabetes drugs that the FDA approved in March of 2013. The drug, marketed in the U.S. by Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), is approved for use in conjunction with diet and exercise to lower blood glucose levels in patients with type 2 diabetes. But, according to Public Citizen, patients should not use the drug because it poses risks that outweigh its benefits.

The drug’s developer conducted nine randomized controlled trials of Invokana to determine its effectiveness. These trials lasted six to 12 months and involved a total of approximately 10,000 subjects. The results of the trials demonstrated that the drug only modestly reduced hemoglobin A1c levels when used alone or in combination with other oral diabetes medications.

What ultimately matters to patients with diabetes, however, is whether the treatment improves survival or reduces diabetic complications, the most important being cardiovascular disease (such as heart attacks and strokes), kidney failure and diabetic retinopathy, which can lead to blindness.

Eight of the nine randomized controlled trials were not designed to measure any such clinically meaningful results, and the one trial designed to evaluate adverse cardiovascular outcomes actually suggested worse cardiovascular outcomes in the subjects who received Invokana in comparison to those receiving other FDA approved diabetes medications.

Public Citizen’s Health Research Group testified before the FDA on Jan. 10, 2013, strongly opposing approval of Invokana because of multiple serious safety concerns and lack of evidence for any clinically meaningful benefit.

Several pieces of evidence from the randomized controlled trials of canagliflozin suggest that the drug may increase the risk of adverse cardiovascular events compared to control subjects treated with a placebo or other diabetes drugs.

The FDA, in a warning on its website, said that diabetes medications like Invokana may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones.

The FDA has identified 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors (diabetes medications) between March 2013 to June 6, 2014. The warning said all the affected patients required emergency room visits or hospitalization to treat the condition.

Since June 2014, the agency said it had continued to receive additional adverse event reports of diabetic ketoacidosis and ketoacidosis in patients treated with SGLT2 inhibitors such as Invokana.