Want your insurance company to pay for next drunk?

According to the FDA they in fact might be willing!  All kidding aside, the FDA has issued a drug safety communication regarding the risk of intoxication with some of the intravenous generic prostate cancer chemotherapy (docetaxel) formulations containing ethanol.

The drugs are marketed as generic docetaxel and under the brand names Taxotere, Docefrez, and Docetaxel Injection.

The intoxication warning was issued based on a review of the FDA Adverse Event Reporting System database and medical literature that revealed three cases of alcohol intoxication associated with docetaxel. In the review, intoxication occurred during docetaxel infusion for two patients and within 24 hours for the third.

“The alcohol content in a dose of docetaxel may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized, including patients with hepatic impairment,” the FDA cautioned in a Drug Safety Communication.

In the case samples used to create the new warning, various methods were utilized to avoid intoxication. In one situation, a slower infusion rate successfully allowed for the completion of therapy.  Besides slowing the infusion rate you can also have your doctor consider a different formulation of docetaxel that contain lower alcohol content.

The FDA rated eight formulations of docetaxel and ranked them in order of their ethanol content. The highest concentration of ethanol within a 200 mg dose of docetaxel was found in a version of the injection manufactured by Pfizer. This formulation contained 6.4 grams of ethanol per dose. Additionally, a version of docetaxel manufactured by Sandoz contained 5.5 grams per dose.

The FDA’s advisory directed that physicians should “consider a docetaxel formulation with the lowest possible alcohol content for patients who experience adverse reactions.”

In the FDA ratings the lowest concentration was found in a two-vial formulation of the drug manufactured by Sanofi, with 2 grams per 200 mg dose. The next lowest ethanol level was found in Docefrez, manufactured by Sun Pharma, at 2.9 grams per dose. Various other formulations of the drug contained doses ranging from 3.7 grams to 4.0 grams per 200 mg dose.
The FDA also went on to advise that doctors counsel their patients on the possible risk of intoxication with docetaxel prior to the administration of the drug. Additionally, they noted that certain medications, such as pain relievers and sleep aids, could adversely interact with the alcohol within docetaxel during infusion worsening the effects.

Remember, don’t chemotherapy and drive.


The FDA Warning at:



FDA Podcast of the warning at:


Joel T. Nowak, M.A., M.S.W.