Life-threatening adverse drug reaction to paclitaxel. Postmarketing surveillance

The mechanism of action of hypersensitivity reactions from paclitaxel has not been fully understood. It has not even been defined if they are secondary to paclitaxel, its vehicle or the premedication. Post-marketing pharmacovigilance is predominantly based on spontaneous reporting. These reports albeit biased and incomplete serve to detect previously unrecognised adverse events.