Mention Acute Kidney Injury as ADR in the package insert of PPIs: CDSCO

  • Posted on: 6 November 2019
  • By: PharmaTutor News

Pharma Admission

pharma admission

 

Proton Pump Inhibitors (PPIs) like Pantoprazole, Omeprazole, lansoperazole, Esomeprazole, Rabeprazole etc are having adverse drug effect which lead to acute kidney Injury. And due to that CDSCO requested the State Drugs Controllers to direct the manufacturers of Proton Pump Inhibitors to incorporate Acute Kidney Injury as an Adverse Drug Reaction in the package insert leaflet of the drugs.

 

Various formulations of Proton Pump Inhibitors like Pantoprazole, Omeprazole, lansoperazole, Esomeprazole, Rabeprazole etc are marketed in the country. And these medications are widely prescribed by physicians, even available as Over the Counter (OTC) medicines.

The National Co-ordination Centre for Pharmacovigilance Programme of India (NCC-PvPl), functioning at IPC Ghaziabad has forwarded their recommendation based on ADR reports on certain medicinal products including Proton Pump Inhibitors which were discussed by them in the 15th Signal Review Panel (SRP) meeting held on August 2019 at Indian Pharmacopoeia Commission, National Coordination Centre- Pharmacovigilance Programme of India (PvPI) with an objective to detect Signal/Prescnbing Information Leaflet change from Indian data and promote patient safety.

In the meeting, the SRP has evaluated the drug Proton Pump Inhibitors -ADR on the basis of Individual Case Study Reports (ICSR) and recommended to PvPI that CDSCO be informed to take necessary steps to incorporate Acute Kidney Injury as an Adverse Drug Reaction into the PIL of the Proton Pump Inhibitors marketed in India.

 

Subsequently, the SRP-PvPI recommendations were deliberated in the Subject Expert Committee (SEC-Antimicrobial & Antiviral) meeting held on October 2019 at CDSCO, New Delhi. After detailed deliberation the committee recommended that CDSCO should request the State Drugs Controllers to direct the manufacturers of Proton Pump Inhibitors to incorporate Acute Kidney Injury as an Adverse Drug Reaction in the package insert leaflet of the drugs.

CDSCO said, "The recommendation of the SEC has been considered by this office. Accordingly, State Drugs Controllers are requested to direct the manufacturers of formulations of Proton Pump Inhibitors under their jurisdiction to mention Acute Kidney Injury as an adverse drug reaction in the Package insert/ Promotional Literature of the said drugs."

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