FDA warns of risk of intoxication due to alcohol content of chemotherapy drug.
A commonly prescribed cancer drug by the name of docetaxel, has recently been found to be the cause of three cases of alcohol intoxication in patients. Docetaxel is a chemotherapy drug used to treat various types of cancer including head, neck, stomach, breast, lung and prostate cancers.
The United States Food and Drug Administration’s (FDA) Adverse Event Reporting System database identified the three cases of docetaxel-related alcohol intoxication. Two of the patients experienced intoxication symptoms during treatment, and the third patient displayed symptoms within 24 hours of being administered the injection form of the drug. The drug contains ethanol, widely known as alcohol, as a solubility-aiding agent, dissolving the active agents of the drug so that it can be administered intravenously (through an IV line).
Docetaxel is available in numerous forms, from generic versions to brand-names including Taxotere, Docefrez and Docetaxel Injection. The products vary in their ethanol content, and physicians should exercise their option to choose from a variety of ethanol doses, while keeping in mind the patient’s contra-indications for ethanol consumption as utmost priority. Extra consideration should be taken for patients who are on additional medications, especially pain relievers and sleep aids, as these medications have the potential to interact with the alcohol and exacerbate the intoxication effects.
The FDA released the safety announcement on June 20, along with a statement dictating their intent to revise all docetaxel product labels to clearly indicate the ethanol content, and warn about the potential risk of intoxication. Furthermore, the announcement advised that patients being treated with docetaxel should avoid activities that could be dangerous under the influence of alcohol for up to two hours after infusion. Activities include, but are not limited to, driving and operating machinery.
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