The U.S. Food and Drug Administration (FDA) has made a safety announcement regarding the chemotherapy drug docetaxel. The agency says that people may feel intoxicated during or after treatment with docetaxel.
On Friday, June 20, the agency released an official statement warning people that docetaxel is composed of ethanol, which is also known as alcohol. People may feel drunk during or after being treated with the intravenous chemotherapy drug.
"Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer. Several forms of docetaxel are currently marketed, including generics and the brand-name products Taxotere, Docefrez, and Docetaxel Injection. The various products contain different amounts of alcohol, which is used to dissolve the active ingredients so docetaxel can be given intravenously (see Docetaxel Formulations and Alcohol Content)," per the FDA safety announcement.
The safety announcement was issued after a search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature found three cases of patients experiencing alcohol intoxication after being treated with docetaxel. The agency suggests that there was a strong but temporary link between the infusion of docetaxel and alcohol intoxication in the patients who were treated with the drug. According to the FDA, one patient felt intoxicated within 24 hours of docetaxel infusion, while two patients experienced intoxication during the infusion of docetaxel.
The FDA also says that in a separate patient, the infusion rate was slower and the symptoms of intoxication also finished when the treatment was over.
As a precautionary method, patients treated with docetaxel in the previous two hours should refrain from operating machinery, driving or performing any other activity that can be dangerous. The FDA also advises that a patient should ensure that they tell their healthcare professional all the medicines they are taking. Patients should also notify their healthcare professional if they feel sleepy, confused or intoxicated during or a few hours post the drug infusion.
The FDA suggests that healthcare professionals must check ethanol contents of docetaxel when prescribing or deliberating the drug to patients, especially when the drug is given along with other drugs. FDA is also revising the labels of all docetaxel products to warn people about the related risks.
