Taxotere vs Taxol - FDA Warning Letter to Sanofi-Aventis

Taxol vs Taxotere

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Both drugs are from the taxane family. Most studies show that the drugs are about the same efficacy in treating breast cancer, and work well combined with other treatments. Taxotere and Taxol have different side effects, but Taxotere may cause permanent irreversible hair loss, while Taxol does not.

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Taxotere Hair Loss

Both Taxotere (Docetaxel) and Taxol (Paclitaxel) are chemotherapeutic medications which work to inhibit cancer cell division (mitosis).Until recently patients were not warned of the risk of permanent Taxotere hair loss, at least in the United States. Sanofi-Aventis warned health care officials in some European countries as early as 2005, but only notified the United States Food and Drug Administration (FDA) of this side effect in 2015, at which time they also included the information on their insert for the drug for U.S. marketing.

On their website Taxotere page Sanofi listed “short term hair loss” as a very common side effect, with a disclaimer that “in most cases normal hair growth should return.” A reason the company may be engaging in word games is because they know nobody would take their drug if they knew they might likely incur permanent hair loss and there’s an equally effective alternative which does not cause permanent alopecia.

Taxotere Compared to Taxol

FDA Misbranding Letter to Sanofi-Aventis Regarding Taxotere

On April 16, 2009 the FDA sent a letter to MaryRose Salvacion, the Director of US Marketing Affairs for Sanofi-Aventis, warning that the company’s claim that Taxotere works better than Taxol was false, and amounted to the federal crime of Misbranding. One can still find some published research articles online which claim Taxotere works better than Taxol and, when you scroll down to look carefully at the documentation and the writer’s credentials, you find the writer received support/some kind of benefit from Sanofi.

Taxotere Lawsuit

Patients who survived breast cancer and their hair did not grow back have filed lawsuits against Sanofi-Aventis alleging failure to warn of the possible side effect of permanent hair loss. If patients had been warned of this possibility they may have opted for the equally effective chemo drug Taxol, which does not cause permanent hair loss. The fact that Sanofi was actively engaging in misbranding along with failing to disclose the horrific side effect to cancer patients in the United States (they warned health officials in some European countries as early as 2005) only makes their behavior in preying on our cancer patients more reprehensible.

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