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Health Minister discusses side-effects of SGLT-2 inhibitors in the parliament

Meghna A SinghaniaWritten by Meghna A Singhania Published On 2021-02-08T16:10:03+05:30  |  Updated On 8 Feb 2021 4:10 PM IST
Health Minister discusses side-effects of SGLT-2 inhibitors in the parliament
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New Delhi: With the rising incidence of diabetes in the country, SGLT-2 inhibitors have emerged as one of the preferred modality of treatment. However, like any other medicines, this class of medicines also come with their own reported side effects.

Through a written reply the Minister of State in the Ministry of Health and Family Welfare, Shri Ashwini Kumar Choubey informed the members of the Lok Sabha about the adverse drug reactions associated with the use of these new class of anti-diabetes medicines (SGLT-2 inhibitors) in India. The minister provided clear detailed breakup of side effects noted with these 4 types of SGLT-2 inhibitors associated in India, namely, Canagliflozin, Dapagliflozin, Empagliflozin and Remogliflozin for the state of Karnataka.

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

Responding to the question of 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, the minister informed that 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 of pancreas inflammation (acute and chronic).

"United States Food & Drug Administration (USFDA) in its DruRg 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 has been examined in consultation with Subject Expert Committee (SEC) and information available under the pharmacovigilance programme of India has also been obtained," the minister informed

Accordingly, CDSCO has requested all State Drug Controllers to direct the manufacturers of SGLT2 inhibitor class drugs such as Canagliflozin, Dapagliflozin, Empagliflozin, etc. 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 Co- transporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier's gangrene.

Further, all the State Drug Controllers have been requested to direct the manufacturers of SGLT 2 inhibitor class drugs to include suitable warning in the package insert and promotional literature of these drugs, the minister informed

Responding to Adverse events reported in the State of Karnataka, the minister provided The details of adverse effects in respect of SGLT-2 inhibitors reported under the Pharmacovigilance Programme of India (PvPI) from Karnataka as below

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 gangrene

4

Remogliflozin

6

  • Hyponatremia
  • Genital candidiasis
  • Asymptomatic hypoglycemia
  • Skin trophic ulcer

· Polyuria

  • Bilateral pneumonia



DiabetesDiabetes medicinesanti DiabetesLok SabhaSGLT2 inhibitorSGLT-2 inhibitorCanagliflozindapagliflozinRemogliflozinempagliflozinadverse drug reaction
Meghna A Singhania
Meghna A Singhania

Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She is a member of the Association of Healthcare Journalists. She can be contacted at meghna@medicaldialogues.in. Contact no. 011-43720751

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