Risk of severe liver damage during prolonged and / or high-dose use of KETAMINE PANPHARMA 50 mg / 5 ml, solution for injection (I.V.-I.M) and KETAMINE RENAUDIN 10 mg / ml solution for injection

KETAMINE PANPHARMA 50 mg / 5 ml, solution for injection (I.V.-I.M) and KETAMINE RENAUDIN 10 mg / ml solution for injection

Ten cases of severe liver damage since 2014, four which resulted in Liver transplantation, have recently been reported by National Security of Medicines and Health product in France.
These cholestatic cholangitis are likely to be related to the administration of ketamine
Repeatedly and / or prolonged (between 1 and 5 months of continuous treatment) and at high dosages, int the management of rebellious pain (exceeding 100 mg / d continuous over several days) and pain treatment (200 to 400 mg / h in 3 to 6 hours) in severe burns.

KETAMINE PANPHARMA 50 mg/5 ml, injectable solution  (IV – IM) PANPHARMA SA

Tel : + 33 (0)2 99 97 92 12

Mail : pharmacovigilance@panpharma.fr

KETAMINE RENAUDIN 10 mg/ml,  injectable solution

 LABORATOIRE RENAUDIN

Tel : +33 (0)5 59 29 74 90

Mail : infomed@labo-renaudin.com

http://ansm.fr