Circular · Safety Notice AIFD · Güvenlik Duyuruları 12.03.2024

12.03.2024 Ornidazol İçeren İlaçlar- Acil Güvenlilik Kısıtlaması Görüş Katkı

AIFD Portal Source TR · Download Original (PDF) EN · Download Translation (PDF)
TR EN ZH RU DE AR FR JA
EN: This is the official English version published by the authority (TİTCK), imported from the AIFD Legislation Portal archive. The binding text is the official Turkish version.

12.03.2024 Ornidazol İçeren İlaçlar- Acil Güvenlilik Kısıtlaması Görüş Katkı_EN

Turkish Ministry of Health Turkish Medicines and Medical Devices Agency

Number: E-24931227-510.01.09-1414378 12.03.2024 Subject: Ornidazole-containing products – Urgent
Safety Restriction

FILE

The Agency has given consideration to the reports of liver failure requiring liver transplantation with products containing ornidazole that were reported to TÜFAM. Accordingly, the wording provided in the attachment must be incorporated in the local Summary of Product Characteristics (KÜB) and Package Leaflet (KT) of said products.
Please forward any opinions, views and suggestions regarding the foregoing to the Pharmacovigilance Risk Management Unit at the Pharmacovigilance and Controlled Substances Department by 29.03.2024, and refrain from making any submissions to the Pharmacologic Assessment Unit in the mean time.
For your information and appropriate action.

Dr. Asım Hocaoğlu Agency President

Distribution: Turkish Pharmaceutical Manufacturers’ Association
Association of Research-Based Pharmaceutical Companies
Pharmaceutical Manufacturers’ Association of Türkiye
Health Products Association

Bears a secure electronic signature. Verification code: ZW56ak1UZW56YnUyRG83ak1UZ1AxZW56 Document Tracking Address: https://www.turkiye.gov.tr/saglik-titck-ebys.
1 | 2

Turkish Ministry of Health Turkish Medicines and Medical Devices Agency

LOCAL SUMMARY OF PRODUCT CHARACTERISTICS […]

4.4 Special warnings and precautions for use

Cases of acute liver failure and, in some cases, severe toxic hepatitis requiring liver transplantation have been reported in Türkiye in patients receiving ornidazole alone or in combination with other drugs. Close monitoring of hepatic enzymes is recommended during treatment.

[…]

4.8 Undesirable effects

Hepatobiliary disorders Not known: Pancreatitis, jaundice, hepatocellular liver injury, cholestatic or mixed-type hepatitis and elevated liver enzymes (AST, ALT, ALP, GGT) which may be reversible by stopping treatment have been reported.
Cases of acute liver failure and, in some cases, severe toxic hepatitis requiring liver transplantation have been reported in patients receiving ornidazole alone or in combination with other drugs. Close monitoring of hepatic enzymes is recommended during treatment.(see Section 4.4).

LOCAL PACKAGE LEAFLET […]

  1. What you need to know before taking

EXERCISE CAUTION when using in the following cases:

Cases of acute liver failure and, in some cases, severe toxic hepatitis requiring liver transplantation have been reported in Türkiye in patients receiving ornidazole alone or in combination with other drugs. Close monitoring of hepatic enzymes is recommended during treatment.

[…]

  1. Possible side effects

Frequency not known: • Pancreatitis, jaundice, hepatocellular liver injury, cholestatic or mixed-type hepatitis and elevated liver enzymes (AST, ALT, ALP, GGT) which may be reversible by stopping treatment have been reported. • Cases of acute liver failure and, in some cases, severe toxic hepatitis requiring liver transplantation have been reported in patients receiving ornidazole alone or in combination with other drugs.

Bears a secure electronic signature. Verification code: ZW56ak1UZW56YnUyRG83ak1UZ1AxZW56 Document Tracking Address: https://www.turkiye.gov.tr/saglik-titck-ebys.
2 | 2