Statewide Study of Chloramphenicol Therapy and Fatal Aplastic Anemia

Wallerstein, Ralph O.

doi:10.1001/jama.1969.03160110017004

Cited by 246 publications

(42 citation statements)

References 4 publications

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“…This can make it more difficult to determine if a specific case of aplastic anemia is drug induced. In addition, most of the cases of apparent chloramphenicol-induced aplastic anemia occurred a month, often several months, after the drug was stopped (Sharp, 1963;Wallerstein et al, 1969). There is both direct and indirect evidence that drug-induced aplastic anemia is immune mediated.…”

Section: Hematologic Adverse Reactionsmentioning

confidence: 99%

Idiosyncratic Adverse Drug Reactions: Current Concepts

Uetrecht

Naisbitt

2013

Pharmacological Reviews

269

256

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Section: Hematologic Adverse Reactionsmentioning

confidence: 99%

Idiosyncratic Adverse Drug Reactions: Current Concepts

Uetrecht

Naisbitt

2013

Pharmacological Reviews

269

256

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“…Unfortunately, the drug was used unnecessarily for the treatment of other diseases shortly after its introduction, and a number of cases of blood dyscrasia, some fatal, caused by chloramphenicol were reported (Erslev, 1964;Wallerstein et al 1969;Report, 1971). Many practitioners, therefore, now hesitate to use it, even in typhoid fever.…”

Section: Introductionmentioning

confidence: 99%

The problem and implications of chloramphenicol resistance in the typhoid bacillus

Anderson

1975

J. Hyg.

137

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SUMMARYTransferable chloramphenicol resistance has become common in the typhoid bacillus in countries such as Mexico, India, Vietnam and Thailand. Situations such as this, and others analogous to it in many parts of the world, are the result of the long-term indiscriminate use of chloramphenicol and other antibiotics in the affected areas. They can be rectified only by more rational antibiotic usage.

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“…per day for premature infants that can be extended into the first week of life of the full-term infant. Wallerstein et al (1969) studied the reports of 225 000 deaths that occurred in the State of California in the period 1 January 1963 to 30 June 1964 with a special focus on fatalities related to aplastic anaemia. It appeared that the risk of developing fatal aplastic anaemia was about 13 times higher among individuals treated orally with chloramphenicol than in the general population.…”

Section: Case Studies Upon Topical Ophthalmic Administrationmentioning

confidence: 99%

Scientific Opinion on Chloramphenicol in food and feed

2014

EFS2

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Chloramphenicol is an antibiotic not authorised for use in food-producing animals in the European Union (EU). However, being produced by soil bacteria, it may occur in plants. The European Commission asked EFSA for a scientific opinion on the risks to human and animal health related to the presence of chloramphenicol in food and feed and whether a reference point for action (RPA) of 0.3 µg/kg is adequate to protect public and animal health. Data on occurrence of chloramphenicol in food extracted from the national residue monitoring plan results and from the Rapid Alert System for Food and Feed (RASFF) were too limited to carry out a reliable human dietary exposure assessment. Instead, human dietary exposure was calculated for a scenario in which chloramphenicol is present at 0.3 µg/kg in all foods of animal origin, foods containing enzyme preparations and foods which may be contaminated naturally. The mean chronic dietary exposure for this worst-case scenario would range from 11 to 17 and 2.2 to 4.0 ng/kg b.w. per day for toddlers and adults, respectively. The potential dietary exposure of livestock to chloramphenicol was estimated to be below 1 µg/kg b.w. per day. Chloramphenicol is implicated in the generation of aplastic anaemia in humans and causes reproductive/hepatotoxic effects in animals. Margins of exposure for these effects were calculated at 2.4 × 10 5 or greater and the CONTAM Panel concluded that it is unlikely that exposure to food contaminated with chloramphenicol at or below 0.3 µg/kg is a health concern for aplastic anaemia or reproductive/hepatotoxic effects. Chloramphenicol exhibits genotoxicity but, owing to the lack of data, the risk of carcinogenicity cannot be assessed. The SUMMARYChloramphenicol is a broad-spectrum antibiotic effective against Gram-positive and Gram-negative bacteria and, in the past, has been widely used to treat infections in both humans and animals. Chloramphenicol is not authorised for use in food-producing animals in the European Union (EU) but may be used in human medicine and in treatments for non-food-producing animals. Apart from its potential occurrence as a residue in food from illicit treatment of food-producing animals, chloramphenicol has also been used in feed and food enzyme products and may occur naturally in plants from its production by the soil bacterium Streptomyces venezuelae.The EFSA Scientific Opinion entitled "Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin" identified an approach for establishing RPAs for various categories of non-allowed pharmacologically active substances. However, the opinion also identified certain categories of non-allowed pharmacologically active substances that are considered to be outside the scope of the procedure, including substances causing blood dyscrasias (aplastic anaemia) such as chloramphenicol. As chloramphenicol is excluded fro...

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Statewide Study of Chloramphenicol Therapy and Fatal Aplastic Anemia

Cited by 246 publications

References 4 publications

Idiosyncratic Adverse Drug Reactions: Current Concepts

Idiosyncratic Adverse Drug Reactions: Current Concepts

The problem and implications of chloramphenicol resistance in the typhoid bacillus

Scientific Opinion on Chloramphenicol in food and feed

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