The PRAC has concluded that there is no evidence of a change in the known risk of neutropenic enterocolitis in the European Union (EU) after treatment with docetaxel, a cancer medicine.
Neutropenic enterocolitis is a serious inflammatory condition of the intestine which is known to occur in up to 1 in 1,000 cancer patients taking the medicine.
Having considered available data on docetaxel, the Committee concluded that the recent rise in reporting of the condition observed in France could be due to increased awareness among healthcare professionals. Reporting rates in the EU as a whole do not provide any evidence of an increase in the incidence of neutropenic enterocolitis.
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