Lok Sabha Question No. 1067 (UNSTARRED), answered on 2020-09-18
Subject: Anti-Diabetes Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: M.K. Vishnu Prasad, K. Shanmuga Sundaram

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

## LOK SABHA UNSTARRED QUESTION NO. 1067 TO BE ANSWERED ON 18 TH SEPTEMBER, 2020

## ANTI - DIABETES MEDICINES

## 1067. DR. VISHNU PRASAD M. K.: 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 the use of a new class of anti - diabetes medicines (SGLT - 2 inhibitors) in India;
- (b) if so, the details thereof and action taken thereon;
- (c)  whether  the  Government  has  r eceived  any  adverse  reports  with  regard  to  the  use  of  thi medicine particularly in Tamil Nadu; if so, the details thereof;
- (d) whether the Drug Controller of India ( D C I ) has given permission to market this med in India; if so, the details 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 medicine?

## 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 Hea 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 Comm unications (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 serious rare infection, called nec fasciitis of the perineum, is also referred to as Fournier 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) an information available under the pharmaco vigilance programme of India has also been obtained.

Accordingly, CDSCO has requested all State Drug Controllers to direct the manufacturer SGLT2 inhibitor class drugs such as Canagliflozin, Dapagliflozin, Empagliflozin, etc. unde jurisdic tion to include the following warning in the package insert and promotional litera 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 rare infection, called necrotizing fasciiti 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 Canagliflozin + Metform Dapagliflozin  +  Metformin,  Empagliflozin  +  Metformin  &  Empagliflozin  +  Linagliptin  an manufacture/market of Remogliflozin and Remogliflozin + Metformin.

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

## Annexure

|   S. No. | SGLT2 Inhibitors   |   No. of Reports | Adverse Reactions                                                                                                                                                                                 |
|----------|--------------------|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       01 | Dapagliflozin      |               10 | Balanoposthitis Muscular Weakness Haematuria Weight Gain Pyelonephritis Urinary Tract Infection Ketosis Dizziness Glomerular Filteration decreased Blood Creatinine increased Increased Urination |
|       02 | Empagliflozin      |               08 | Urinary Tract Infection Blood Creatinine increased Acute Kidney Injury Sepsis Numbness Euglycemic Ketoacedosis Leucorrhoea Chest Heaviness Burning Micturition Vaginal discharge Hypoaesthesia    |
|       03 | Canagliflozin      |               03 | Vulval abscess Weight Increased Ulvovaginal mycotic Hypotension Thirst                                                                                                                            |
|       04 | Remogliflozin      |               01 | Cystitis                                                                                                                                                                                          |

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