European Union regulators are reviewing a generic version of Taxotere, following reports that five French patients have died from neutropenic enterocolitis following treatment with docetaxel. The review is being carried out by the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), and follows the launch of a similar review by the French National Drug and Health Product Safety Agency (ANSM) earlier this month.
Docetaxel has been available in Europe since 1995, and is sold under a number of trade names, including Taxotere. The deaths reported in France occurred since August 2016, mostly among women being treated for breast cancer. Neutropenic enterocolitis is a known, but rare, docetaxel side effect that may be seen in up to 1 in 10,000 patients. That five fatalities would be seen over such a short period of time is unusual.
Neutropenic enterocolitis occurs when a part of a large intestine called the cecum becomes inflamed. Without proper treatment, it may result in bowl perforation or death.
The EMA noted that PRAC’s preliminary assessment indicates that the frequency of this complication has not increased in the last two years. A thorough evaluation of available data is being carried out and final conclusions will be published once the review is completed. Healthcare providers have been advised to continue prescribing docetaxel according to recommendations in the current product information, including detailed recommendations for the prevention and management of neutropenia.
Sanofi-Aventis received U.S. Food & Drug Administration (FDA) approval to market Taxotere in 1996. The first generic version of docetaxel was cleared in 1992. The drug’s approved indications now include breast cancer, head and neck cancer, gastric cancer, prostate cancer and non-small cell lung cancer.
Name-brand Taxotere is currently the subject of a large U.S. litigation involving its alleged propensity to cause permanent alopecia, or hair loss. In December 2015, the drug’s U.S. labeling was updated to note that cases of permanent alopecia had been reported among patients treated with the drug. However, plaintiffs pursuing Taxotere lawsuits claim that Sanofi has long provided information regarding the potential for permanent hair loss to individual patients and regulatory agencies overseas. Their complaints also cite several studies that suggest hair loss associated with Taxotere is more likely to be permanent compared to alopecia that occurs with alternative, equally effective chemotherapy drugs.
The majority of Taxotere lawsuits have been filed in a multidistrict litigation currently underway in the U.S. District Court, Eastern District of Louisiana. Nearly 800 cases were pending in that proceeding as of March 15th.