Recently, the U.S. Food and Drug Administration (FDA) has issued an alert about three patients who have reported they feel intoxicated after taking in docetaxel, a chemotherapeutic drug.
The agency has asked companies manufacturing docetaxel to label prominently that the drug contains ethyl alcohol or ethanol. The FDA recommended health care professionals to be alert about a possibilty of patients feeling intoxicated after their chemotherapy treatment and asked to consider the use of more concentrated docetaxel to ensure the patient get a very small amount of alcohol.
Docetaxel is used for the treatment of breast cancer, non-small cell lung cancer, prostate cancer that doesn't respond to hormone therapy, head cancer, neck cancer and melanoma.
Manufacturers like Pfizer, Sandoz, Hospira, Accord and Activas sell the drug under the generic name while Sanofi and Sun Pharma Global sell them under the original brand name, Taxotere and Docefrez, respectively.
Patients, after being injected with even a small amount of alcohol, given intravenously could produce side effects that could be perceived as intoxication.
FDA has made the following recommendations to health care professionals, as reported in Forbes:
- Cases of intoxication have been reported with some formulations of docetaxel due to the alcohol (ethanol) content.
- The alcohol content in a dose of docetaxel may affect the central nervous system and should be taken into account for patients with whom alcohol intake should be avoided or minimized, including patients with hepatic impairment.
- Take into consideration the alcohol content in docetaxel on patients' ability to drive or use machines one to two hours after the infusion.
- Consider a docetaxel formulation with the lowest possible alcohol content for patients who experience adverse reactions.
- Slowing the infusion rate during administration may help resolve symptoms of alcohol intoxication.
- Monitor patients for signs of alcohol intoxication during and after treatment.
- Counsel patients about the possible effects of the alcohol content in docetaxel, including possible effects on the central nervous system.
- Report adverse events involving docetaxel to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.