Lok Sabha Question No. 1950 (UNSTARRED), answered on 2021-07-30
Subject: Anti Diabetes Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: P. Velusamy, K. Shanmuga Sundaram

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARR ED QUESTION NO. 1950 TO BE ANSWERED ON 30 TH JULY, 2021

## ANTI DIABETES MEDICI NES

## 1950.SHRI VELUSAMY P.: SHRI SHANMUGA SUNDAR AM K.:

Will the Minister of HEALTH AND FAMILY WE LFARE be pleased to state:

- (a) whether the Government is aware of the adverse drug reactions associated with the us new class of anti - diabetes medicines, SGLT - 2 inhibitors in India;
- (b) if so, the details ther eof;
- (c) whether the Government has received any adverse reports on the above medicines from State of Karnataka, if so, the details thereof;
- (d) whether the Drug Controller of India has given permission to market this medicine in I so, the deta ils thereof; and
- (e)  the  steps  taken  by  the  Government  to  create  awareness  among  the  millions  of  dia patients in India against the usage of SGLT - 2 use?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE ( DR. BHARATI PRAVIN PAWAR )

(a) & (b): Central Drugs Standard Control Organisation (CDSCO) was notified about a Hea Canada  communication  to  all  Sodium - Glucose  Co - transporter - 2  (SGLT2)  inhibitor  Marketing Authorization  Holders  regarding  a  Summary  Safety  Review  (SSR)  on  the  p otential  risk  of pancreas inflammation (acute and chronic).

United States Food & Drug Administration (USFDA) in its Drug Safety Communications (DSC) stated that cases of rare but serious infection of the genitals and area around th have been rep orted with use of SGLT2 inhibitors. This serious rare infection, called necro fasciitis  of  the  perineum,  is  also  referred  to  as  Fournier's  gangrene.  USFDA  has  revised  the labels of SGLT 2 inhibitors to include new warnings about the risk to patients.

The issue has been examined in consultation with Subject Expert Committee (SEC) o CDSCO and information available under the pharmacovigilance programme of India has als been obtained.

Accordingly, CDSCO has requested all State Drug Controllers to dire ct the manufacturers of SGLT2 inhibitor class drugs such as Canagliflozin, Dapaglifloz Empagliflozin, etc. under their jurisdiction to include the following warning in the pack and promotional literature of these drugs:

Warning -Cases  of  a  r are  but  serious  infection  of  the  genitals  and  area  around  t genitals have been reported with this class of type 2 diabetes medicines i.e., Sodium - Glucose Co transporter - 2  (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciiti e perineum, is also referred to as Fournier's gangrene.

(c): The  details  of  adverse  effects  in  respect  of  SGLT - 2  inhibitors  reported  under  the Pharmacovigilance Programme of India (PvPI) from Karnataka are as per Annexure .

(d) & (e): CDSCO has given permission to import/market formulations of following SGLT -2 inhibitors: Canagliflozin, Dapagliflozin & Empagliflozin including Fixed Dose Combinat (FDC) like Canagliflozin + Metformin, Dapagliflozin + Metformin, Empagliflozin + Metform in & Empagliflozin + Linagliptin and manufacture/market of Remogliflozin and Remogliflozin Metformin.  Further,  all  the  State  Drug  Controllers  have  been  requested  to  direc manufacturers of SGLT 2 inhibitor class drugs to include suitable warning in t h p ckage sert and promotional literature of these drugs.

## Adverse Drug Reactions associated with the use of SGLT - 2 inhibitors reported from Karnataka.

|   S.No | SGLT - 2 Inhibitors   |   No. of Reports | Adverse Effects                                                                                                                                             |
|--------|-----------------------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
|      1 | Canagliflozin         |                3 | Muscle weakness Urinary tract infection Encephalopathy Sepsis Diabetic ketoacidosis Kidney dysfunction                                                      |
|      2 | Dapagliflozin         |                7 | Burning sensation Heartburn Epigastric discomfort Ketoacidosis Hypoglycaemia Glycosuria Lichen Planus Urinary tract infection Genital infection Weight loss |
|      3 | Empagliflozin         |                7 | Rash Itching Balanitis Hyperacidity Laziness Lethargy Appetite lost Somnolence Retching Nausea Urinary tract infection Hyperkalaemia Fournier gangrene      |
|      4 | Remogliflozin         |                6 | Hyponatremia Genital candidiasis Asymptomatic hypoglycemia Skin trophic ulcer Polyuria Bilateral pneumonia                                                  |