Lok Sabha Question No. 4910 (UNSTARRED), answered on 2022-04-01
Subject: Adverse Reaction of Anti-diabetes Medicine
Ministry: HEALTH AND FAMILY WELFARE
Asked by: P. Velusamy

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

## LOK SABHA UNSTARRED QUESTION NO. 4910 TO BE ANSWERED ON 01 st  APRIL, 2022

## ADVERSE REACTION OF ANTI-DIABETES MEDICINE

4910: SHRI VELUSAMY P.:

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

(a) whether the Government has taken note of adverse drug reactions associated with the use of a new class of anti-diabetes medicines, SGLT-2 inhibitors in the country, if so, the details thereof;

(b) whether the Government has received adverse reports of these medicines from States/UTs particularly from the State of Tamil Nadu, if so, the details thereof;

(c) whether the Drug Controller of India has given permission to market this medicine in the country, if so, the details thereof; and

(d)  the  steps  taken  by  the  Government  to  create  awareness  among  millions  of  diabetic patients in the country against the usage of SGLT-2?

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

(a): Central Drugs Standard Control Organization (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  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  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  was  examined  in  consultation  with  Subject  Expert  Committee  (SEC)  of CDSCO and information available under the Pharmacovigilance Programme of India (PvPI) has also been obtained.

Accordingly,  CDSCO  has  requested all State Drug  Controllers to direct the manufacturers of SGLT2 inhibitor class drugs named Canagliflozin, Dapagliflozin, Empagliflozin, under their jurisdiction to include the following warning in the package insert and promotional literature of 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 Cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier's gangrene.'

(b): The details  of  adverse  effects  (no.  of  adverse  drug  reactions  reported)  in  respect  of SGLT-2 inhibitors reported under the PvPI from Tamil Nadu are as below :

Euglycaemic diabetic  ketoacidosis  (3),  Urinary  tract  infection  (3),  Burning  micturition  (2), Dysuria (2), Serum creatinine increased (2), Genital inflammation (1), Balanitis (1), Genital redness (1), Chest heaviness (1), Cough (1), Cystitis (1), BUN increased (1), Hemoptysis (1), Hypotension  (1),  Leukorrhoea  (1),  Numbness  of  upper  arm  (1),  Pyelonephritis  (1),  SGPT increased (1), Thirst excessive (1), Vaginal candidiasis (1), Urination frequency (1), Weight increase (1).

(c) & (d): CDSCO has given permission to import/market formulations of following SGLT-2 inhibitors: Canagliflozin, Dapagliflozin & Empagliflozin including Fixed Dose Combinations (FDC)  like  Dapagliflozin  +  Metformin  HCL,  Empagliflozin  +Linagliptin,  Empagliflozin  + Metformin HCL, Canagliflozin + Metformin HCL , Dapagliflozin + Metformin, Remogliflozin Etabonate + Metformin  Hydrochloride,    Saxagliptin  + Dapagliflozin , Remogliflozin Etabonate + Vildagliptin, Remogliflozin Etabonate + Teneligliptin Hydrobromide Hydrate, Remogliflozin Etabonate + Vildagliptin + Metformin Hydrochloride. Further,  all  the  States  were  requested  to  direct  the  manufactures  of  SGLT  2  inhibitor  class drugs to include warning in the package insert and promotional literature of these drugs.

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