April 21, 2016 — Sanofi-Aventis has recalled Taxotere (docetaxel) in the United Kingdom because it could be too potent.
The problem is that a production error may have allowed some ethanol to evaporate, which could increase the concentration of Taxotere in the solution. The error was traced to a software failure during filling of the batch. The incidence rate for the 4ml presentation is estimated to be about 0.09%.
Description of recalled Taxotere:
- Taxotere (Docetaxel) Concentrate for Solution for Infusion, 80mg per 4ml EU/1/95/002/004 — Batch #5F219A — Expiration Date 31 August 2018.
Taxotere was previously recalled in the United States in March 2001 due to a labeling error. The manufacturer received one report of a 20-mg vial with the active drug that was inadvertently labeled as a “diluent” vial.
In June 2014, the FDA issued a Safety Communication to warn that ethanol (alcohol) in Taxotere may cause patients to “experience intoxication or feel drunk during and after treatment.” Cases of intoxication have been reported with some formulations of Taxotere. Slowing the infusion rate during administration may help relieve symptoms. According to the FDA:
“Patients should avoid driving, operating machinery, or performing other activities that are dangerous for one to two 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 intoxicating effects.”
Taxotere was approved by the FDA in May 1996 for advanced breast cancer after other treatments had failed. It belongs to a class of chemotherapy drugs called taxanes, which were developed from the poisonous yew tree. Taxotere is a powerful weapon in the fight against cancer, but it is also very toxic — especially when combined with other chemotherapy drugs.
Sanofi-Aventis is facing a growing number of lawsuits from women who were diagnosed with permanent alopecia (hair loss) after undergoing breast cancer treatment. They say drug-makers knew or should have known about the risk for years but failed to provide patients or doctors with adequate warnings.
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