Welcome to the FDA Drug Safety Podcast for healthcare professionals from the Division of Drug Information. Today’s topic: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment.
On June 20, 2014, FDA issued a Drug Safety Communication warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. We are revising the labels of all docetaxel drug products to warn about this risk. Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications.
Patients should be aware that docetaxel may cause them to become intoxicated from the alcohol it contains. Patients should avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after docetaxel infusion. Additionally some medications, such as pain relievers and sleep aids, may interact with the alcohol in the docetaxel infusion and worsen the intoxicating effects.
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 health care professionals should be aware of in order to monitor and counsel patients appropriately.
Report side effects with docetaxel to FDA’s MedWatch program at www.fda.gov/medwatch.
Thank you for listening. A link to the full communication detailing specific information for healthcare professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications.
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