Taxotere Side Effects Investigated In France After Five Deaths

Following reports of at least five deaths linked to Taxotere side effects, France’s national cancer institute is recommending doctors there avoid using the chemotherapy drug to treat some cases of breast cancer. 

The French National Drug and Health Product Safety Agency (ANSM) issued a letter to oncologists (in French) last month, warning that Taxotere may be responsible for a number of deaths from neutropenic enterocolitis, which causes the mucosa in the colon and small intestines to become inflamed. The letter recommended doctors instead use Abraxane for treatment of localized, operable breast cancer

All five deaths occurred since August 2016, and involved women ranging in age from 46 to 73. Investigators began looking at the issue following the third death.

Researchers note that all of the deaths were associated with the use of generic Taxotere, docetaxel, and not the brand-name drug itself. However, their investigation turned up no irregularities in the generic drug, which is supplied by the Indian drug company Accord Healthcare, and tests indicated that it meets quality standards.

The ANSM is continuing its investigation and anticipates releasing the results on March 28.

Taxotere Hair Loss Lawsuits

The warning comes as the maker of brand-name Tazotere, Sanofi-Aventis, faces a growing number of Taxotere lawsuits in the U.S., involving allegations that inadequate warnings were provided for women and the medical community about the risk of permanent hair loss associated with the drug.

Taxotere (docetaxel) was introduced in 1996, as a high potency taxane-based cancer drug. Although it was marketed as a superior alternative to existing low-potency taxanes, such as Taxol, plaintiffs allege that it is no more effective, yet has been linked to reports of hair problems that continue long after chemotherapy treatments are complete.

Although the drug maker allegedly knew about the Taxotere permanent baldness risk, plaintiffs maintain that Sanofi-Aventis wrongfully withheld information from physicians, healthcare providers, patients and the public.

While Taxotere warnings in several other countries were previously updated to include information about the risk of permanent baldness, that same information was not provided to American women and doctors, the allegations indicate.

In October 2016, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all cases over Taxotere alopecia side effects filed in federal courts nationwide, centralizing the lawsuits before one judge in the Eastern District of Louisiana for coordinated pretrial proceedings.

It is likely that a small group of cases will be prepared for early “bellwether” trials to help gauge how juries may respond to certain evidence and expert testimony that will be repeated throughout the litigation. While the outcome of such early trials will not be binding in other cases, they may help the parties reach Taxotere settlements for women suffering permanent baldness or hair loss problems, avoiding the need for dozens of individual trials in courts throughout the U.S.