Lok Sabha Question No. 4344 (UNSTARRED), answered on 2019-07-19
Subject: Adverse Drug Reaction
Ministry: HEALTH AND FAMILY WELFARE
Asked by: K. Shanmuga Sundaram, Magunta Sreenivasulu Reddy

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

LOK SABHA UNSTARRED QUESTION NO. 4344 TO BE ANSWERED ON 19 TH JULY, 2019

## ADVERSE DRUG REACTIO N

## 4344. SHRI SHANMUGA SUNDARAM K.: SHRI MAGUNTA SREENIVASULU REDDY:

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

- (a) whether the Government is aware about a report on the adverse drug reactions assoc with the use of a new class of anti - diabetes medicines (SGL T-2 inhibitors) in India;
- (b) if so, the details thereof and the action taken thereon;
- (c) whether the Drug Controller of India has given the permission to market this medic India and if so, the details thereof;
- (d) whether the  Ministry  is  having  any  details  of  these  medicines  being  used  and  its  ad effects reported in Tamil Nadu and if so, the details thereof; and
- (e)  the  steps  taken  by  the  Government  to  create  awareness  among  millions  of  people  in regard?

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

(a) & (b): Yes. Central Drugs Standard Control Organisation (CDSCO) was notified by the concerned  company  about  a  Health  Canada  communication  to  all  Sodium - Glucose  Co transporter 2 (SGLT2) inhibitor Marketing Authorization Holders regarding a Summary Safe Review (SSR) on the potential risk of pancreas inflammati o ( cute 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 i nhibitors. This serious rare infection, called necrotizi 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 be en 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 th manufact urers 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 rare but serious infection of the genitals and area around the genitals hav been reported with this class of type 2 diabetes medicines i.e., Sodium - Glucose C transporter - 2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the pe al so referred to as Fournier's gangrene (c): CDSCO  has  given  permission  to  import/market  formulation  of  following  SGLT - 2 inhibitors:  Canagliflozin,  Dapagliflozin  &  Empagliflozin  including  FDC  like  Canaglifloz Metformin,  Dapagliflozin  +  Metformin, Empagliflozin  +  Metformin  &  Empagliflozin  + Linagliptin and manufacture/market of Remogliflozin. (d) & (e):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. As stated above, all the State Drug Controllers have been requested to direct the manuf of  SGLT  2  inhibitor  class  drugs  to  include  suitable  warning  in  the  package  inser promotional literature of these drugs.

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## Annexure

|   S.No | SGLT - 2 Inhibitors   |   No. of Reports | Adverse Effects                                                                                                                                                                        |
|--------|-----------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|      1 | Canagliflozin         |                3 | Vulval abscess Weight increased Ulvovaginal mycotic infection Hypotension Thirst                                                                                                       |
|      2 | Dapagliflozin         |                9 | Balanoposthitis Muscular weakness Haematuria Weight increased Pyelonephritis Urinary tract infection Ketosis Dizziness Glomerular filtration rate decreased Blood creatinine increased |
|      3 | Empagliflozin         |                6 | Blood creatinine increased Acute kidney injury Sepsis Urinary tract infection Vaginal discharge Hypoaesthesia Chest discomfort                                                         |