Common diabetes drugs will have to carry warnings about genital infection

Drug controller following warnings by Canada and US authorities makes warnings mandatory on some diabetes drugs

Diabetes drugs such as canagliflozin, dapagliflozin will have to carry a mandatory warning about the risk of genital infection.

In a circular issued on March 25, the Drug Controller General of India (DCGI) has mandated that the warning about necrotising fasciitis of the perineum or Fournier’s gangrene will have to be carried on all SGLT2 inhibitors.

Sodium glucose co transporter 2 (SGLT2) lowers blood sugar by helping kidneys to remove sugar from the body. This prevents it from entering the blood.

Sodium glucose co transporter 2 (SGLT2) lowers blood sugar by helping kidneys to remove sugar from the body. This prevents it from entering the blood

In its communication to state drug controllers asking them to ensure that the warnings are carried in all the specified medicines. The Central Drugs and Standards Control Organisation has said that it has received safety updates in the drug from Health Canada and USFDA.

In a directive issued last year, USFDA said: “Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away”

It went on to add: “Health care professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.”

India has one of the highest diabetes burdens in the world. SGLT2 inhibitors are commonly used in the country, doctors say.