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Prop 65: Listing of Chloramphenicol Sodium Succinate (September 2013)

UPDATE:
California’s Office of Environmental Health Hazard Assessment (OEHHA) added chloramphenicol sodium succinate to the list of chemicals known to the State to cause cancer under Proposition 65. The listing is effective as of September 27, 2013.

The documentation supporting OEHHA’s determination that the criteria for listing chloramphenicol sodium succinate have been satisfied are included  here.

PREVIOUS INFORMATION:
California’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice of intent to list the chemical chloramphenicol sodium succinate as known to the State to cause cancer under Proposition 65. OEHHA has come to this determination based on FDA’s identification that blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia and granulocytopenia) have resulted after both short term and prolonged therapy with chloramphenicol. FDA-approved product labels require a warning of “serious and fatal blood dyscrasias” that are “known to occur after the administration of chloramphenicol.” In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia.


OEHHA is requesting comments from the public as to whether chloramphenicol sodium succinate meets the criteria for listing under Proposition 65. OEHHA has asked that comments be limited to whether FDA requires that chloramphenicol sodium succinate be labeled to communicate a risk of cancer or tumors. OEHHA cannot consider comments pertaining to the quality of evidence considered by FDA. The public comment period will remain open until 5:00pm PT on Tuesday, September 3, 2013.

For detailed information on OEHHA’s notice of intent to list, please click here.

For more information, please
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