April 7, 2017 — Health officials in Europe are investigating Taxotere after five people died of a severe intestinal inflammatory side effect called neutropenic enterocolitis.
Sanofi Aventis, the manufacturer of Taxotere, is accused of downplaying the risk of side effects in around 800 lawsuits in the United States involving permanent hair loss.
The top health agency in France (ANSM) was surprised at the number of deaths associated with Taxotere. The risk of death from Taxotere was also investigated by the European Medicines Agency (EMA).
The Institut Curie in France has stopped using Taxotere for now, replacing it with a similar chemotherapy drug, Taxol (paclitaxel).
EMA determined that the rate of death has not changed over the last two years. ANSM is also not banning Taxotere, according to an agency director who spoke with Medscape:
A risk–benefit assessment will need to be made if it is decided to withdraw docetaxel from the market, to suspend its marketing. This is presently being looked at.”
Neutropenic enterocolitis is caused by neutropenia, or low numbers of infection-fighting white blood cells. Neutropenia is the most commonly reported side effect of Taxotere. Neutropenic enterocolitis is estimated to occur in 1 in 10,000 patients on Taxotere.
All five people died after August 2016. They all used a generic version of Taxotere that is made by an Indian drug company. The products in question were tested immediately, but no issues were discovered.
Taxotere is a life-saving cancer drug, but it can also cause death. It is a more powerful version of Taxol (paclitaxel), with more serious side effects. Taxotere is recommended for women with fast-growing breast cancer. Women with slow-growing breast cancer say they would have chosen Taxol instead of Taxotere if they knew they might go bald.
Sanofi added permanent alopecia to drug-labels in the United States in December 2015, long after updating labels in other countries. Labels were updated in Canada in 2005 and Europe in 2012.
Lawsuits involving women who did not re-grow their hair are currently centralized in one federal court in Louisiana — MDL No. 2740. The number of Taxotere lawsuits has tripled to 800 cases since mid-December 2016.
Women with hair loss are not the only ones accusing Sanofi Aventis of downplaying side effects. In January 2017, U.S. District Judge Lawrence Stengel refused to dismiss a whistleblower lawsuit accusing the company of training sales representatives to downplay Taxotere risks.
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