A Minnesota woman says she was never properly warned that she was at risk for permanent hair loss from Taxotere.

Plaintiff Debbie R. says she developed permanent alopecia, or hair loss, after undergoing chemotherapy with Taxotere.

She now says the drug’s manufacturer Sanofi and its related companies failed to properly warn about the risk of permanent alopecia associated with this drug.

She alleges Sanofi deceptively overstated the benefits associated with Taxotere while simultaneously failing to properly disclose the drug’s associated risks.

Taxotere, also known by the generic name docetaxel, is a chemotherapy drug frequently used to treat breast cancer. After an earlier rejection by the FDA, Taxotere was finally approved for use in the U.S. in 1996.

Dealing with Permanent Hair Loss from Taxotere

Taxotere is one of a group of chemo drugs known as taxanes. These drugs prevent the growth of cancer cells by interfering with the movement of chromosomes during cell division.

According to this Taxotere lawsuit, Taxotere can cause permanent alopecia, or hair loss, which Debbie says is particularly disfiguring for women.

Debbie notes that hair loss is a common side effect of chemotherapy treatment, but for that hair loss to be permanent is out of the ordinary

She cites a clinical study known as GEICAM 9805, in which persistent alopecia was observed in 9.2 percent of patients who took Taxotere. Alopecia in those patients lingered for a mean follow-up time of over 10 years, Debbie says.

Debbie further alleges Sanofi engaged in an overly-aggressive marketing campaign that misled patients as to the risk of permanent hair loss from Taxotere.

She says that in November 2003, the FDA sent a letter to Aventis Pharmaceuticals – a predecessor to today’s Sanofi – warning the company that three of its direct-to-consumer advertisements for Taxotere were misleading. The FDA said these advertisements suggested that Taxotere was more effective than had been demonstrated by substantial evidence or clinical experience.

In the same letter, Debbie says, the FDA points out that the advertisements in question do not mention the risks associated with Taxotere, including the risk of hair loss.

Debbie says that when the GEICAM 9805 study came out in 2007, the defendants issued a press release announcing the results of that study that showed the efficacy of Taxotere.

But the defendants failed to alert the public or the medical community about the number of patients in that study who showed signs of permanent hair loss from Taxotere, Debbie says.

Later, in April 2009, the FDA sent another letter warning that promotional materials for Taxotere overstated the drug’s efficacy and misleadingly suggested that it was superior to Taxol, another taxane, in treating certain types of cancer.

Debbie’s Taxotere lawsuit  raises claims for failure to warn, negligence and fraud. She seeks a damage award including general and punitive damages, restitution and disgorgement of profits, and reimbursement of attorneys’ fees and court costs.

The Taxotere Permanent Alopecia Lawsuit is Case No 0:16-cv-03018, in the U.S. District Court for the District of Minnesota.