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Cancer Drug Docetaxel May Cause Symptoms of Alcohol Intoxication, FDA Warns

Agency to revise labels of all docetaxel products

The FDA is warning that the intravenous chemotherapy drug docetaxel, which contains ethanol, may cause patients to experience intoxication or to feel drunk during and after treatment.

The agency is revising the labels of all docetaxel 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 those in 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 1 to 2 hours after the infusion of docetaxel. In addition, some medications, such as pain relievers and sleep aids, may interact with the alcohol in the docetaxel infusion and worsen the drug’s intoxicating effects.

Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head, and neck, as well as non–small-cell lung cancer.

Several forms of docetaxel are currently marketed, including generics and the brand-name products Taxotere (docetaxel injection, Sanofi-Aventis) and Docefrez (docetaxel anhydrous, Sun Pharma Global). The various products contain different amounts of alcohol, which is used to dissolve the active ingredients so that docetaxel can be given intravenously. To monitor and counsel patients appropriately, health care professionals should be aware of the differences in these formulations.

Source: FDA; June 20, 2014.

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