In the United States, around 800 lawsuits have been filed by women who suffered permanent hair loss after chemotherapy with Taxotere. All of them accuse Sanofi Aventis of failing to warn about side effects.

Neutropenia is the most frequently-reported side effect of Taxotere, according to a warning from the French health regulatory agency ANSM, but they were surprised at the number of deaths.

For now, France is not banning Taxotere despite the deaths. Dr. Dominique Martin, director of the ANSM explained to 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.”

All five deaths occurred after August 2016 in patients aged 46 to 73 years old. They all used a generic version of Taxotere made by the Indian pharmaceutical company Accord Healthcare (Intas Pharmaceuticals).

Taxotere (Docetaxel)

The quality of the Taxotere lots in question was checked immediately. No issues were discovered. Even so, the Institut Curie announced it was stopping use of Taxotere and replacing it with Taxol (paclitaxel).

Taxotere and Taxol are both chemotherapy drugs in the taxane class, but Taxotere is more powerful. Taxotere is also more likely to cause side effects like neutropenia and permanent baldness.

Many women say they would have chosen Taxol instead of Taxotere if they knew their hair might not grow back. Up to one third of breast cancers are slow-growing and do not need aggressive treatment.

Warnings about permanent hair loss were added to the Taxotere drug-label in Canada in 2005 and Europe in 2012. However, Sanofi did not update American drug-labels until December 2015.

The number of Taxotere lawsuits has tripled over the last four months. Lawsuits nationwide have been centralized in one federal court in Louisiana (MDL No. 2740).

Earlier this year, U.S. District Judge Lawrence Stengel refused to dismiss a whistleblower lawsuit against Sanofi Aventis. A former sales representative says the company trained employees to downplay side effects of Taxotere and paid kickbacks to doctors who prescribed it.

Sanofi is a French drug-maker, but they say the U.S. Constitution protects their free speech to advertise Taxotere for uses that are not approved by the FDA. This so-called “off-label” marketing is blatantly illegal unless the speech is truthful and not misleading — and that’s now a question for a jury to decide.

Source: Taxotere lawsuit filings surge in Louisiana

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Elizabeth Bradley

Posted by Elizabeth Bradley

Lifelong consumer advocate. Pop culture nerd. Grammar evangelist. Wannabe organizer. Travel addict. Zombie fan.

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