Warnings for People with Hepatitis C and Liver Disease

Ned Tijdschr Geneeskd 1997 Mar 15;141(11):540-542

Severe hepatitis attributed to paroxetine.

[Article in Dutch]

de Man RA

Academisch Ziekenhuis Rotterdam-Dijkzigt, afd. Maag-, Darm- en Leverzieklen.

A 52-year-old man suffering from chronic hepatitis B related liver cirrhosis was treated for depression with paroxetine (Serotax) 5 mg and subsequently 15 mg once daily. A severe hepatitis with liver failure (jaundice, hypoalbuminaemia, edemas, and ascites) developed. After the drug was withdrawn the patient recovered completely. The adverse reaction may be explained by a change in the pharmacokinetics of the drug caused by the liver cirrhosis. Caution is required in prescribing long-term paroxetine therapy for patients with documented liver cirrhosis. The liver function should be monitored and administration of the drug should be discontinued when functional disturbances are noticed.

PMID: 9190513, MUID: 97248929

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Fatal acute fulminant liver failure due to clozapine: a case report and review of clozapine-induced hepatotoxicity

Clozapine-induced hepatotoxicity is not well known and is usually of no clinical significance. This report describes fatal acute fulminant liver failure caused by clozapine in a 39-year-old man with chronic paranoid schizophrenia. The hepatotoxicity of clozapine is reviewed. Asymptomatic elevation of transaminase levels is observed most commonly, affecting between 30% and 50% of patients. Icteric hepatitis is uncommon, noted in 84 of 136,000 patients (0.06%). Fatal acute fulminant hepatitis has been documented in 2 patients (0.001%). The mechanism of clozapine hepatotoxicity is unknown. Although serious toxicity is rare, prescribers of clozapine should be aware of the hepatotoxic potential.

Author: Macfarlane B, Davies S, Mannan K, Sarsam R, Pariente D, Dooley J,

Department of Medicine, Royal Free Hospital School of Medicine, London,

England.

Source: Gastroenterology 112 (5): 1707-1709 (May 1997)

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July 26, 1996

Herbal Medicine; "Hepatitis after the Use of Germander, a Herbal Remedy."

Hepatitis Weekly via Individual Inc. : According to the authors' abstract of

an article published in Canadian Medical Association Journal, "The authors

report two cases of hepatic injury associated with the ingestion of

germander, a herbal medicine used to facilitate weight loss. In both

patients, hepatitis characterized by asthenia jaundice and a marked increase

in serum aminotransferase levels occurred after 5 to 6 months of germander

use. The jaundice disappeared within 8 weeks after germander use was

stopped, and the overall outcome was favourable. The subsequent resumption

of germander therapy by one patient was soon followed by the recurrence of

hepatitis. Similar reports from France have led to the banning of germander

in that country. Like several other herbal remedies, germander may be

hepatotoxic, and many herbal medicines may not be as safe as the public

generally assumes."

The corresponding author for this study is: JP Villeneuve, Hop St Luc, Ctr

Rech Clin Andre Viallet, Div Hepatol, 264 Rene Levesque Blvd E, Montreal, Pq

H2X 1P1, Canada. For subscription information for this journal contact the

publisher: Canadian Medical Association, 1867 Alta Vista Dr, Ottawa on K1G

3Y6, Canada.

AUTHORS: Laliberte, L.; Villeneuve, J.P.

SOURCE: Canadian Medical Association Journal, June 1, 1996;154(11):1689-1692.

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WESTPORT, May 02 (Reuters) - The botanical dietary supplement, chaparral,

has been liked to chronic irreversible liver damage with fulminant hepatic

failure.

The botanical, also know as "creosote bush" and "grease-wood," is used in a

variety of natural "...burn salves, weight-loss teas, liver tonics, blood

purifiers, cancer cures, and treatments of chronic cutaneous disorders,"

according to FDA investigator Dr. Nasreen M. Sheikh. Dr. Sheikh and

colleagues in Washington, DC, and at the CDC in Atlanta, Georgia, reviewed

18 reports of chaparral-associated adverse events submitted to the FDA

between 1992 and 1994.

"Ingestion of chaparral appears to be associated with hepatotoxicity,

including toxic or drug-induced cholestatic hepatitis and possible fulminant

liver failure," Dr. Sheikh said. In 13 of the 18 reported cases ,the FDA and

CDC investigators found evidence of hepatotoxicity.

Onset of symptoms was anywhere between 3 weeks and 52 weeks after ingestion

of the botanical, and symptoms "...resolved 1 to 17 weeks after most

individuals stopped their intake of chaparral." Two patients required liver

transplantation.

The clinical presentation of hepatotoxicity was consistent between the

cases, including "...jaundice, marked increases in liver-associated

chemistry levels, and histopathological features of hepatocellular necrosis,

cholestasis, cholangitis, and cirrhosis." Dr. Sheikh's team points out that

the symptoms of botanical hepatotoxicity are often similar to those observed

in cases of viral hepatotoxicity.

The authors "...encourage health professionals to inquire routinely about

the use of dietary supplements and other products, to be alert to potential

adverse effects that may be associated with the use of such products, and,

finally, to report any serious adverse events associated with these products

through the FDA MEDWatch Program."

Arch Intern Med 1997;157:913-919.

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