Product News and Recalls

Consumer Advocates Speak Out against Off-Label SGLT2 Inhibitor Promotion

public citizen speaking out about off-label marketing In a recent letter to the U.S. Food and Drug Administration (FDA), Public Citizen, a 350,000-member consumer advocacy group, spoke out against the apparent off-label promotion of certain sodium-glucose cotransporter 2 (SGLT2) inhibitors. The group takes issue with direct-to-consumer advertisements for five different drugs: Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide), and Bydureon (extended-release exenatide). According to Public Citizen, ads in print magazines and online are inappropriately promoting the possible weight-loss, and in some cases blood pressure reduction, benefits of these drugs.

SGLT2 inhibitors are a relatively new class of diabetes drugs approved for treatment of type 2 diabetes. Earlier this year, the FDA released a safety communication warning about a possible link between SGLT2 inhibitor use and ketoacidosis, a severe and potentially fatal blood condition. The FDA, as well as Health Canada, has launched an investigation into the matter.

Meanwhile, medical experts are expressing concern about SGLT2 inhibitors and the way they affect ketoacidosis diagnosis in diabetic patients. Numerous medical case reports demonstrate that diabetic patients who use SLGT2 inhibitors can present with normal blood sugar levels, making it difficult for health care professionals to quickly recognize and treat ketoacidosis. The problem is especially prevalent in treatment of type 1 diabetic patients, who have been prescribed SGLT2 inhibitors off-label. Medical specialists are urging hospital staff to look out for ketoacidosis in patients with normal blood glucose levels, and to question patients about the type of diabetes medication they are using.

The letter from Public Citizen is concerned not with off-label promotion of type 1 diabetes treatment but with the promotion of SGLT2 inhibitors for their weight-loss, and sometimes blood pressure reduction, benefits. These “beneficial” side effects are a result of how SGLT2 inhibitors work. Unlike other diabetes medications, SGLT2 inhibitors lower blood sugar by preventing its reabsorption in the kidneys and disposing of it through urine. The consequent loss of sugar decreases patients’ daily caloric intake, leading to weight loss. Increased urination from SGLT2 inhibitor use also eliminates extra water, resulting in lowered blood pressure.

Public Citizen argues that these benefits, which in advertisements are placed close to the drugs’ approved indications, “convey the false perception to patients and doctors that the drugs have been deemed safe and effective for weight loss and/or reducing blood pressure.” Inflating these benefits skews the risk–benefit analyses of patients and practitioners deciding whether or not to use SGLT2 inhibitors. The advocacy group provides pictures of print and online advertisements demonstrating the allegedly deceptive placement of weight-loss and blood pressure reduction side effects.

Public Citizen urges the agency to require the manufacturers of these drugs to withdraw any ads promoting off-label use.

Consult your doctor or physician before stopping or starting any medications. If you or a loved one was diagnosed with ketoacidosis or otherwise injured by an SGLT2 inhibitor, contact Lopez McHugh today for a free consultation with one of our experienced pharmaceutical lawyers. You may be entitled to legal compensation through an Invokana lawsuit.