A Kentucky woman who has experienced permanent hair loss after chemo is suing the manufacturers of Taxotere (docetaxel).

Plaintiff Belinda B. says she was prescribed Taxotere for treatment of breast cancer from May through July 2002.

She says that neither she nor her doctor were aware of the possibility of permanent hair loss, also known as alopecia.

Most chemotherapy treatments result in temporary hair loss, but Taxotere has become associated with claims of permanent hair loss – a side effect that plaintiffs like Belinda say was hidden from the medical community and consumers for years.

Taxotere Claimed Superiority Over Other Chemo Treatments

The FDA originally rejected approval of Taxotere over concerns related to its high toxicity. Taxotere was allegedly more toxic than its main competitor Taxol, which had already received FDA approval.

The FDA approved Taxotere in 1996, originally as its label indicated “for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.”

The makers of Taxotere allegedly claimed it was superior to other chemotherapy drugs, a claim based upon self-sponsored clinical trials. More specifically, Taxotere’s makers said it was more effective than the less potent Taxol.

However, according to the Taxotere lawsuit, “[a] study of available clinical studies concerning the relative efficacy of taxanes in the treatment of breast cancer published in the August 2007 journal Cancer Treatment Review concluded that no significant differences were found in the efficacy and outcomes obtained with Taxotere or Taxol.”

Another study published in 2008 in the New England Journal of Medicine actually determined that Taxol was more effective than Taxotere when patients underwent “standard adjuvant chemotherapy with doxorubicin and cyclophosphamide.”

Even after these studies were published, Taxotere continued to be promoted as the superior choice, Belinda claims.

In 2009, the FDA sent a warning letter to Taxotere manufacturer Sanofi-Aventis, telling the company to stop publishing promotional materials for Taxotere that contained “unsubstantiated superiority claims,” overstating the drug’s efficacy.

Permanent Hair Loss After Chemo

Belinda claims that due to the drug maker’s claims of superiority and the hiding of the fact that permanent alopecia could be a side effect, many more women were exposed to the risks than would have been had they known the true facts regarding Taxotere’s efficacy and the possibility of permanent hair loss after chemo.

The drug maker is accused of misleading the public and the medical community that patients’ hair would grow back as it does after other chemotherapy treatments.

“Defendants knew or should have known that the rate of permanent alopecia related to Taxotere was far greater than with other products available to treat the same condition,” Belinda claims.

In fact, a study called GEICAM 9805 published in 2005 showed that 9.2 percent of patients who took Taxotere experienced permanent hair loss after chemo for up to ten years and five months or even longer.

According to Belinda’s Taxotere lawsuit, the drug maker “knowingly, intentionally, and wrongfully withheld these results contained in the GEICAM 9805 study from physicians, healthcare providers, patients, and Plaintiff in the United States.”

Belinda further alleges that “as a direct result of Defendants’ wrongful and deceptive acts, thousands of women were exposed to the risk of disfiguring permanent alopecia without any warning and without any additional benefit.”

The Taxotere Permanent Hair Loss After Chemo Lawsuit is Case No. 2:16-cv-17907 in the U.S. District Court for the Eastern District of Louisiana.