Back to Alerts List

Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication

[Posted 06/20/2014]

AUDIENCE: Oncology

ISSUE: FDA is 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. FDA is revising the labels of all docetaxel drug products to warn about this risk.

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

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/20/2014 -Drug Safety Communication - FDA]

Related Safety Alerts

Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant [Posted 8/3/2018]
Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy [Posted 5/18/2018]
Extracorporeal Photopheresis (ECP) Treatment : Letter to Health Care Providers - Death and Pulmonary Embolism [Posted 2/6/2018]
Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions [Posted 1/16/2018]
Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold [Posted 8/31/2017]
Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure [Posted 4/25/2017]
Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) [Posted 3/21/2017]
Radiation Therapy Devices by Multidata Systems International: Discontinue Use ? Concerns about Risks to Patients [Posted 10/20/2016]
Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use [Posted 9/7/2016]
BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries [Posted 5/13/2016]