Lok Sabha Question No. 1040 (UNSTARRED), answered on 2019-11-22
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. 1040 TO BE ANSWERED ON 22 ND NOVEMBER, 2019

## ANTI - DIABETES MEDICINES

## 1040. SHRI SHANMUGA SUNDARAM K.

Will the Minister of HEALTH AND FAMILY WELFARE 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, the details thereof;
- (c) whether the Government is having ny details of adverse reports/reactions of these medicines pertaining to Tamil Nadu and if so, the details thereof;
- (d) whether the Drug Controller of India has given permission to market thismedicine in India and if so, the details thereof; and
- (e)  the  steps  taken  by  the  Government to  create  awareness  among  the  millions  of diabetic patients in India against the usage of SGLT- 2?

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

- (a) & (b): 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 Summar y Safety Review (SSR) on the potential 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 the genitals have been reported with use of SGLT2 inhibitors. This serious rare infection, called nec fasciitis of the perineum, is also referred to as Fournier gangrene. USFDA has revised t 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) an information available under the pharmacovigilance programme of India has also been obtaine

Accordingly, CDSCO has r equested all State Drug Controllers to direct 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 literat ure of these drugs:

Warning -Cases of a rare but serious infection of the genitals and area around the g have  been  reported  with  this  class  of  type  2  diabetes  medicines  i.e.,  Sodium - Glucose Cotransporter - 2 (SGLT2) inhibitors. This serious r are infection, called necrotizing fasciitis of th 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 Tamil Nadu are as per Annexure .

(d): CDSCO  has  given  permission  to  import/market  formulation  of  following  SGLT - 2 inhibitors:  Canagliflozin,  Dapagliflozin  &  Empagliflozin  including  FDC  like  Canaglifloz Metformin,  Dapagliflozin  +  Metformin,  Empa gliflozin  +  Metformin  &  Empagliflozin  + Linagliptin and manufacture/market of Remogliflozin.

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

## Annexure

|   S.N O | SGLT-2 Inhibitors   |   No. of Report s | Adverse Effects                                                                                                                                                                                            |
|---------|---------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Canagliflozin       |                 3 | Vulval abscess Weight increased Ulvovaginalmycotic infection Hypotension Thirst                                                                                                                            |
|       2 | Dapagliflozin       |                10 | Balanoposthitis Muscular weakness Haematuria Weight increased Pyelonephritis Urinary tract infection Ketosis Dizziness Glomerular filtration rate decreased Blood creatinine increased Increased urination |
|       3 | Empagliflozin       |                 6 | Blood creatinine increased Acute kidney injury Sepsis Urinary tract infection Vaginal discharge Hypoaesthesia Chest discomfort                                                                             |