Lawsuits accuse Sanofi of not providing proper warning about hair loss possibility

ORLANDO, Fla. — A growing number of civil lawsuits allege a popular drug did not provide proper warning to patients that their hair may never grow back.

9 Investigates has learned thousands of patients could be affected and not even realize it.

"It's their way of saying this is strong, but no one said it's going to make you have permanent hair loss," said Vindetta Martin, a breast cancer survivor.

Martin received a certificate when she finished her treatment five years ago and assumed her hair would return.

"I don't even look like myself," said Martin. "I can't even explain it. It's very devastating."

The allegations mirror the claims from more cancer patients in the civil lawsuit against Sanofi.

In the lawsuit, plaintiffs allege, "Taxotere can cause serious medical problems, including permanent alopecia, or hair loss." They claimed the manufacturer "engaged in aggressive marketing and advertising campaign that misled consumers and the medical community as to the drug's safety and efficacy."

Attorney Mark O'Mara represents Martin and Barbara Hill, another breast cancer survivor fighting hair loss.

"You've already been through cancer and survived, why is this drug company making you go through an additional victimizing?"

O'Mara said the federal case will show the company knew permanent hair loss was a possibility because it had already been determined in European studies, and such warnings did not appear in information published in the United States prior to December 2015.

"I wash my hair and I comb it and I see so much hair in the comb and brush," said Hill.

The women told Channel 9 they would've chosen another form of treatment if they had known about the risk of permanent hair loss.

A representative of Sanofi released a statement to Channel 9 on the claims:

Alopecia is one of the most commonly reported adverse reactions associated with some chemotherapy treatments, including across all Taxotere indications.  Sanofi has disclosed that this is a Taxotere side effect since the product was first approved in the U.S. in 1996.

Since its approval, Sanofi has submitted safety information to FDA on an ongoing basis as part of post-marketing regulations, including information concerning persisting and/or permanent alopecia.  This information comes from a variety of sources, including clinical studies, case reports and medical literature.  As early as 2004, Sanofi submitted data about ongoing alopecia to the FDA as part of a proposed Taxotere label update.  Additional information on this condition was subsequently provided to FDA at various points in time, including in 2009 and 2011.  In December 2015, following discussion between FDA and Sanofi, the label was updated to reflect that cases of permanent alopecia have been reported following use of Taxotere, although at an unknown frequency.  All prescribing decisions are made by treating physicians who understand their patient's needs and weigh the risks and benefits of treatment options.