Have hepatic side effects been reported for sertraline?/nA female patient in her 30´s was admitted

Fråga: Have hepatic side effects been reported for sertraline?

A female patient in her 30´s was admitted a fortnight ago with severe liver affection which was suspected to be caused by a combination of alcohol and paracetamol. Five days after discharge from the hospital she was admitted again with gastric pain and high levels of aminotransferases (> 50 ukat/l, normal <0.7 ukat/l) were recorded. The patient had after the discharge from the hospital been prescribed Zoloft (sertraline) because of a depressive symptomatology. She had earlier been treated with imipramine. During hospitalization the transaminase levels have been decreasing and ultrasound has shown normal parenchymal liver tissue. The patient denies continued alcohol abuse which however cannot be excluded.

Sammanfattning: No reports of severe hepatic side effects of sertraline have been found in the literature. Increased levels of aminotransferases have however been reported in 0.5 to 0.8 per cent of sertraline treated patients participating in clinical trials. These increases were reported to diminish promptly upon discontinuation of therapy.

Svar: No published case reports of hepatic side effects of sertraline have been found in the literature. Neither are there any cases reported to the Swedish Adverse Drug Reactions Advisory Committee. According to a review article (1) and contact with the manufacturer (2), 0.5-0.8 per cent of 2700 sertraline treated patients participating in clinical trials discontinued therapy because of increases in aminotransferase levels. These increases were usually seen in the first eight weeks of the treatment and diminished promptly upon discontinuation of the therapy.

In the present case, alcohol and/or other drugs such as paracetamol known to affect liver function appear as a more probable cause of liver affection than sertraline. However, if these other causes appear unprobable the case should be reported to the Swedish Adverse Drug Reactions Advisory Committee. 1 Murdoch D, McTavish D: Sertraline: A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in depression and obsessive-compulsive disorder. Drugs 1992; 44: 604-624 2 Alf Wering, Pfizer, personal communication