Lok Sabha Question No. 838 (UNSTARRED), answered on 2021-02-05
Subject: Anti Diabetes Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: K. Shanmuga Sundaram

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

## LOK SABHA UNSTARRED QUESTION NO. 838 TO BE ANSWERED ON 5 TH FEBRUARY, 2021

## ANTI DIABETES MEDICI NES

## 838. SHRI SHANMUGA S UNDARAM K.:

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

- (a) whether the Government is aware of the fact that adverse drug reactions are associated with the use of a new class of anti - diabetes medicines (SGLT - 2 inhibitors) in India;
- (b) if so, t he details thereof and any such adverse repo ts received from States/UTs particularly Karnataka;
- (c) whether the Drug Controller of India has given permission to market this medicine in India, if so, the details thereof; and
- (d)  the  steps  taken  by  the  Gove rnment  to  create awareness  among  the  millions  of  diabetic patients in India against the usage of SGLT - 2 use?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

(a): Central Drugs Standard Control Organisation (CDSCO) was notified about a Health Canada communication to all Sodium - Glucose Co - transporter - 2 (SGLT2) inhibitor Marketing Authorization  Holders  regarding  a  Summary  Safety  Review  (SSR)  on  the  potential  risk 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 reported with use of SGLT2 inhibitors. This s erious rare infection, called necrotizing 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) and information available under the pharmacovigilance programme of India has also been obtaine

Accordingly, CDSCO has requested all State Drug Controllers to direct the manufacturer SGLT2 inhibito r class drugs such as Canagliflozin, Dapagliflozin, Empagliflozin, etc. under jurisdiction to include the following warning in the package insert and promotional lite these drugs:

Warning -Cases of a rare but serious infection of the genitals and area around the 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 perineum, is also referred to as Fournier's gangrene.

(b):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 .

(c): CDSCO has given permission to import/market formulation of foll wing SGLT - 2 inhibitors: Canagliflozin, Dapagliflozin & Empagliflozin including FDC like Canagliflozin + Metform Dapagliflozin  +  Metformin,  Empagliflozin  +  Metformin  &  Empagliflozin  +  Linagliptin  an manufacture/market of Remogliflozin and Remoglif lozin + Metformin.

(d):  As  stated  above,  all  the  State  Drug  Controllers  have  been  requested  to  dire manufacturers of SGLT 2 inhibitor class drugs to include suitable warning in the package and promotional literature of these drugs.

## Annexure

|   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         |                6 | Burning sensation mucosal Heartburn Epigastric discomfort Ketoacidosis Hypoglycaemia Glycosuria Lichen Planus Urinary tract infection Genital infection |
|      3 | Empagliflozin         |                7 | Rash Itching Balanitis Hyperacidity Laziness Lethargy Appetite lost Somnolence Retching Nausea Urinary tract infection Hyperkalaemia Fournier           |
|      4 | Remogliflozin         |                6 | gangrene Hyponatremia Genital candidiasis Asymptomatic hypoglycemia Skin trophic ulcer Polyuria Bilateral pneumonia                                     |