Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0019158 (hepatitis)
 30,205 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Ketoconazole was first considered as a more or less safe drug. When used on a very large scale, however, it became obvious that this drug, as others mainly metabolized in the liver, can cause liver damage, i.e. chemical hepatitis sometimes even leading to death. Such very rare events seem to be linked to the protracted use of ketoconazole. Taking into account what is now known on the rational use of ketoconazole it still is a drug with a favourable benefit risk ratio.
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PMID:Safety aspects of ketoconazole, the most commonly used systemic antifungal. 270 Feb 24

The imidazoles have been appreciated for approximately fifteen years as a family of antifungals. Most derivatives, like the protype compounds, miconazole and clotrimazole, are effective only in a topical dose form. The topical imidazoles are generally thought to be superior to other topical antifungals. The first orally available imidazole, ketoconazole has ushered in a new era of potent, oral, broad-spectrum antifungal therapy. The imidazoles as a class are the treatment of choice for four dermatophyte infection syndromes. They are the preferred alternative therapy in another six syndromes. There is insufficient data to recommend one topical azole over the other. The topicals are inadequate for control of six clinical-anatomical infection syndromes. Griseofulvin remains the standard oral therapy in all situations except chronic, extensive dermatophytosis, where ketoconazole has proven to be more efficacious. The recognition of potential significant adverse effects, namely an idiopathic hepatitis and dose-dependent adrenal and testicular dysfunction have reduced ketoconazole's potential role in the dermatophytoses. Ketoconazole is a useful alternative to griseofulvin when oral therapy is required and the causative organism is insensitive to griseofulvin, or infection fails to respond to griseofulvin, or griseofulvin is contraindicated due to allergy, photosensitivity, porphyrinuria, intolerance, etc.
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PMID:Consensus of the role and positioning of the imidazoles in the treatment of dermatophytosis. 294 Jul 92

Ketoconazole was introduced in the United Kingdom in 1981. By November 1984 the Committee on Safety of Medicines had received 82 reports of possible hepatotoxicity associated with the drug, including five deaths. An analysis of the 75 cases that had been adequately followed up suggested that 16, including three deaths, were probably related to treatment with the drug. Of the remainder, 48 were possibly related to treatment, five were unlikely to be so, and six were unclassifiable. The mean age of patients in the 16 probable cases was 57.9, with hepatotoxicity being more common in women. The average duration of treatment before the onset of jaundice was 61 days. None of these well validated cases occurred within the first 10 days after treatment. The results of serum liver function tests suggested hepatocellular injury in 10 (63%); the rest showed a mixed pattern. In contrast, the results of histological examination of the liver often showed evidence of cholestasis. The characteristics of the 48 patients in the possible cases were similar. Allergic manifestations such as rash and eosinophilia were rare. Hepatitis was usually reversible when treatment was stopped, with the results of liver function tests returning to normal after an average of 3.1 months. In two of the three deaths probably associated with ketoconazole treatment the drug had been continued after the onset of jaundice and other symptoms of hepatitis. Clinical and biochemical monitoring at regular intervals for evidence of hepatitis is advised during long term treatment with ketoconazole to prevent possible serious hepatic injury.
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PMID:Hepatic reactions associated with ketoconazole in the United Kingdom. 310 6

The authors report a new Ketoconazole-induced hepatitis in which clinical, chemical and histological features show evidence of a cholestatic injury in a 62 yrs-old female recovering once therapy is stopped. In this case-report, delay of onset of the illness is very short for a 200 mg-a-day prescription and no feature leads towards an immune response. This, may be, means that Ketoconazole-induced hepatitis should be led by an idiosyncrasic mechanism. Even if fatal hepatitis are rare, prescriptors have to beware of this therapy.
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PMID:[Cholestatic hepatitis caused by ketoconazole]. 338 21

A new antifungal agent, ketoconazole, has been added to the drugs available for the treatment of fungal infections. Ketoconazole has been shown to be effective in the treatment of mucocutaneous candidiasis with a reported 97% positive response rate. This drug may be administered orally to outpatients with a low risk of toxicity. Hepatitis has been reported as a possible complication of treatment. Infection relapse is the most significant posttherapeutic problem. Five patients suffering from mucocutaneous candidiasis after irradiation therapy are reported to have had favorable responses. The other available antifungal agents are reviewed and discussed.
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PMID:Ketoconazole and the antifungals. 392 Jun 12

We have treated 48 cases of onychomycosis (of which 37 were caused by dermatophytes, 10 by yeasts and one by Scopulariopsis brevicaulis) with 200 mg ketoconazole daily. We obtained recovery in 65 p. 100 of the cases of onyxis caused by dermatophytes and in 80 p. 100 of the cases of onychomycosis due to Candida. The one patient presenting an infection with Scopulariopsis brevicaulis recovered in 13 months. The average duration necessary to obtain complete recovery was 6 1/2 months for onychomycosis of the hands due to dermatophytes and 12 1/2 months for those of the feet. Perionyxis due to Candida needed 2 months of treatment with this drug, however 6 months of treatment were necessary to obtain recovery for onycholysis due to Candida. Biological tests remained normal and the side-effects were minimal and essentially gastrointestinal in our study. Ketoconazole is an effective treatment for onychomycosis: it is active against the different mycotic agents infecting nails and well tolerated by the patient. Several minor effects such as itching, nausea, headache and more serious reactions such as erythrodermia and hepatitis have been reported. Regular control and biological tests are therefore necessary. Patients with other diseases should avoid the use of ketoconazole for treatment of onychomycosis.
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PMID:[Ketoconazole and onychomycosis]. 608 41

Since Oct. 1981 a new systemic antifungal drug Ketoconazole is available in the Federal Republic of Germany that has proven effective even in severe cases with fungal infections. This case-study will call attention on a rare but important side effect, namely Ketoconazole induced hepatitis. As an acute icteric viral hepatitis, type Non-A-Non-B-hepatitis possibly misdiagnosed only a carefully compiled history of the recent intake of drugs points at the real cause of hepatitis. In our case-report we observed a considerable increase in serum enzymes, especially GOT, GPT and GLDH after a drug-challenge with two tablets. We recommend so-called liver functions tests 2 to 3 weeks after beginning of therapy and further-on in monthly intervals. Histologically at that time toxic hydropic changes of the liver cells and a mesenchymal reaction with portal and intralobular mainly eosinophilic infiltration could be established. The serum enzymes came to normal only after 12 weeks.
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PMID:[Ketoconazole-induced hepatitis. Case report]. 614 74

Ketoconazole is an imidazole derivative recently developed as an antifungal agent. There have been only a few established cases of hepatotoxicity in the literature. This report describes a case of presumed ketoconazole hepatotoxicity characterized by the development of severe hepatitis with marked centrilobular necrosis. The lack of hypersensitivity reactions in clinical findings and centrilobular location of necrosis suggested a host idiosyncrasy with metabolic abnormality as the effect of ketoconazole in the present case.
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PMID:Severe hepatitis during ketoconazole therapy. 630 86

A 46-year-old woman had a chronic, unresponsive wrist infection that was proved to be due to the algaelike organism Prototheca wickerhamii. Treatment with ketoconazole resulted in prompt improvement and ultimate healing. Therapy was complicated by hepatitis that was ketoconazole-related. Ketoconazole may be effective and easily administered therapy for this generally unresponsive infection.
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PMID:Successful ketoconazole treatment of protothecosis with ketoconazole-associated hepatotoxicity. 631 Nov 29

Ketoconazole has only recently been recognized as a cause of hepatic injury, with most reports coming from outside the United States. In order to characterize more fully the U.S. experience, we undertook an analysis of 54 reports of alleged ketoconazole-induced liver injury submitted to the Food and Drug Administration from the time of initial marketing in 1980. Thirty-three reports were considered likely instances of ketoconazole-induced hepatitis. The majority of these cases occurred in women more than 40 yr of age. Jaundice was recorded in 27 individuals after therapy of 11-168 days with an average daily dose of 200 mg. Anorexia, malaise, nausea, and vomiting accompanied liver injury in one-third of cases. No instances of rash or eosinophilia were recorded. Serum transaminase and alkaline phosphatase values were consistent with acute hepatocellular injury in 18 patients, with primarily cholestatic injury in 5 patients, and with a mixed pattern in 9 individuals. Only one death seemed attributable to ketoconazole. In that patient, the drug was continued after the appearance of clinical and biochemical evidence of hepatic injury and massive hepatocellular necrosis was present at autopsy. The incidence of symptomatic, potentially serious hepatic injury appears to be very low, perhaps 1 in 15,000 exposed individuals. The presumed mechanism of injury is metabolic idiosyncrasy, although hypersensitivity has not been completely dismissed in some cases reported in the literature. The incidence of mild, asymptomatic, reversible elevations in serum transaminases occurring in ketoconazole recipients has been estimated to be 5%-10%. Periodic biochemical testing and monitoring for symptoms of hepatitis during ketoconazole therapy is recommended to help prevent the development of serious or fatal hepatic injury.
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PMID:Hepatic injury associated with ketoconazole therapy. Analysis of 33 cases. 631 20


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