EMA reviewing cancer medicines containing docetaxel
13.03.2017
The European Medicines Agency (EMA) is investigating the cancer medicine docetaxel following cases of neutropenic enterocolitis in patients in France, most of whom were being treated for operable breast cancer. Neutropenic enterocolitis is a serious inflammatory condition of the intestine associated with neutropenia (low levels of neutrophils, a type of white blood cell that fights infection). It is a known and rare side effect of docetaxel (which may affect up to one in 10,000 people treated with this medicine).
A preliminary assessment by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) indicates that the frequency of this side effect has not increased in the last two years. A thorough evaluation of available data is being carried out and final conclusions will be published once the review is completed.
Docetaxel is an important therapeutic option which has been shown to extend the lives of cancer patients. While the review is ongoing, EMA advises that doctors should continue to prescribe this medicine according to recommendations in the Summary of Product Characteristics (SmPC), including detailed recommendations for the prevention and management of neutropenia.
Patients who have any questions about their treatment should speak to their doctor.
More about the medicine
Docetaxel is a medicine used for the treatment of several types of cancer, including breast cancer. It has been authorised in the EU since 1995 under several trade names including Taxotere.
More about the procedure
The review of docetaxel is being carried out in the context of a safety signal. A safety signal is information on a new, previously unknown, adverse event, or on new, previously unknown aspects of a known adverse event, suspected to be potentially related to a medicine and requiring further investigation.
The review is being carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. Once the review is completed, the PRAC will make any recommendations necessary to minimise risks and protect patients’ health.
