FDA warns type 2 diabetes patients: certain diabetes medications may increase the risk of a potentially life-threatening genital infection. SGLT-2 inhibitors, approved by the FDA in 2013, are prescribed to help reduce blood sugar levels in type-2 diabetes patients. More than a dozen drugs in a class known as SGLT-2 inhibitors (sodium-glucose cotransporter 2 inhibitors) are included in the warning.
“Drug-induced glucosuria, decreased immune response, and altered microflora of the genital region are the main factors responsible for high incidence of genital infections in cases with diabetes. The anticipated association of SGLT2 inhibitors and increased risk of genital infection is a major cause of concern for diabetologists.” – PubMed Central (PMC)
The FDA warning advises that taking these SGLT-2 inhibitors increases the risk of developing a rare bacterial infection known as necrotizing fasciitis of the perineum, or Fournier’s gangrene. This infection of the genitals and the area surrounding the genitals can be deadly. Both males and females are at risk for infection. The bacteria enter the body through broken skin and spread rapidly.
“In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor. This number includes only reports submitted to FDA and found in the medical literature, so there may be additional cases about which we are unaware. ” – The U.S. Food and Drug Administration (FDA)
Patients taking any of the aforementioned drugs should be on the lookout for any of the following symptoms:
If you experience any of these symptoms, a general feeling of sickness, or a fever higher than 100.4 degrees, get medical help immediately. This infection must be treated quickly with antibiotics and surgery.
One death and 11 hospitalizations have been reported since FDA approval of the SGLT-2 inhibitors in 2013. A medical study found a 20% mortality rate for those suffering from the infection. The FDA further stresses that patients using this drug read the accompanying Medication Guide each and every time they refill their prescription for important new information about risks or side effects.
The FDA also requests that patients taking this drug report adverse reactions or side effects. Reports can be filed through the FDA MedWatch voluntary reporting system or by calling 1-800-332-1088.
If you or a loved one has experienced unnecessary pain and suffering from an SGLT-2 inhibitor, please contact Becker Law Office for a free assessment of your case. Our dangerous drug lawyers will discuss the specifics of your drug injury and legal options for pursuing compensation. You are worth it, and we will fight for you.