Over 1,000 breast cancer survivors say Taxotere, a common chemotherapy agent, left them with permanent hair loss. Now, these women are pursuing financial compensation, suing the drug’s manufacturer in a Louisiana federal court.
Did you or a loved one develop permanent alopecia after being administered Taxotere? Contact our experienced attorneys now. Learn more about Taxotere permanent hair loss.
Medical researchers are uncovering increasing evidence that Taxotere, a chemotherapy drug commonly used in breast cancer treatment, harbors risks of persistent hair loss.
Temporary alopecia is a well-known side effect of systemic chemotherapy, but hundreds of cancer survivors who took Taxotere have yet to see normal hair growth return – even years after completing treatment. Over 1,500 women have already filed lawsuits against Sanofi, Taxotere’s manufacturer, claiming that the company failed to issue sufficient warnings, putting patients at risk for distressing hair loss without taking measures to properly inform them beforehand.
On December 11, 2015, Taxotere’s Prescribing Information was updated with a brief mention of the drug’s risks for persistent alopecia in the “common side effects” section:
“in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.”
In the “post-marketing experiences” section, patients are now informed that “cases of permanent alopecia have been reported.” Shockingly, prior to this update, the U.S. label for Taxotere didn’t include any mention of the possibility that patients could lose their hair indefinitely. Alopecia was merely included as a common side effect or adverse reaction, with no clarifications on how long hair loss could potentially last.
Considering Taxotere was first released in the U.S. in 1996, this recent warning has come far too late to benefit thousands of patients who have already received the drug. And although American patients have been left in the dark until now, Taxotere’s label throughout Europe has included permanent alopecia warnings for years – apparent evidence that Sanofi was already aware of these risks long ago yet withheld this knowledge from the American public.
Worse yet, Taxotere’s label used to assure patients that “hair generally grows back” after treatment is completed, likely leading many to believe that the drug only causes temporary hair loss, just like any other chemotherapy agent. However, this statement was quietly removed on May 13, 2010, shortly after alopecia warnings were added to the Taxotere label in Europe.
At least as early as 2009, European labeling for Taxotere included the statement “cases of permanent alopecia have been reported” in its post-marketing data section. Also, in a table on “very common adverse reactions,” a less than 3% incidence of persisting alopecia is listed under “skin and subcutaneous tissue disorders.”
This <3% incidence figure (which is relatively low compared to more recent estimates of 6% to 15% from various post-market Taxotere research studies) was calculated based on pooled data from early clinical trials that examined Taxotere’s effectiveness and possible adverse effects. The results of these trials were already made available to consumers in Europe back in 2005, in a “scientific discussion” on Taxotere’s efficacy and side effects. Two trials in particular, which are comprehensively summarized in Taxotere’s European label, provided revealing follow-up data on persistent alopecia:
The TAX 316 trial focused on a group of 1,491 patients with operable node-positive breast cancer. The patients were selected at random to either receive a “TAC” regimen of doxorubicin, cyclophosphamide, and docetaxel (Taxotere), or an “FAC” regimen of doxorubicin, cyclophosphamide, and fluorouracil. Each regimen was administered every 3 weeks for 6 cycles. This trial yielded positive results for Taxotere by demonstrating that the TAC regimen resulted in longer disease-free survival, reduced rates of cancer relapse, and higher overall 10-year survival rates in comparison to the FAC regimen.
But trial participants in the TAC group also experienced an elevated incidence of side effects, including persistent alopecia. 29 out of 744 TAC patients (3.9%) still suffered from alopecia at the end of the study’s follow-up period versus only 16 out of 736 (2.2%) of patients on the FAC regimen. The median follow-up time for participants was 8 years—clearly demonstrating that these patients were indeed suffering from persistent alopecia.
In this study, 1,060 patients with operable node-negative breast cancer randomly received adjuvant treatment of either a TAC or an FAC regimen, also administered every 3 weeks for 6 cycles. Analyses of the results after a median 125-month follow-up period showed that the TAC group experienced 16.5% less risk of relapse than the FAC group, as well as a positive but statistically insignificant trend in disease-free survival rates for the TAC patients.
Regarding persistent alopecia, 49 out of 532 (9.2%) of TAC-treated patients still struggled with “ongoing” alopecia during the roughly 10-year follow-up period.
These clinical trials were an early indication that Taxotere presents a higher-than-normal risk of persistent alopecia compared to any other chemotherapy drugs. One would think that a roughly 3% chance of developing permanent hair loss should have been significant enough to warrant at least some mention on Taxotere’s label right from the start.
After all, any adverse drug effects that occur with a frequency between 1% and 10% are considered “common” according to standards followed by the European Medicines Agency, which the FDA also uses as a rough guideline for side effect classifications. For context, a higher than 10% incidence is dubbed “very common”; 0.1% to 1% “uncommon”; 0.01% to 0.1% “rare,” and so on.
But why would Sanofi choose to omit a permanent alopecia warning from Taxotere’s U.S. label even while releasing such warnings in Europe and Canada (in May 2012)? According to recent lawsuits filed by Taxotere hair loss victims, the omission was a component of “fraudulent” promotion methods that Sanofi used to manipulate American consumers into considering Taxotere superior to any competitor drugs.
According to these patient lawsuits, Sanofi didn’t merely overlook its duty to inform patients of Taxotere’s permanent hair loss risks, but rather intentionally concealed these and other important safety data in order to make the drug appear more appealing to healthcare providers, the American public, and even the FDA. Plaintiffs say that because of this concealment and other forms of deception performed by Sanofi, “thousands of women were exposed to the risk of disfiguring permanent alopecia without any warning and without any additional benefit.”
The lawsuits draw supporting evidence for their fraud accusations from a Qui Tam lawsuit (commonly known as a “whistleblower” case) filed by former Sanofi employee Yoash Gohil back in 2001. Gohil, who worked as a Sanofi sales representative from Feb 1982 up until he resigned from the position in June 2002, drew heavily upon his insider experience with Sanofi’s “corrupt” hidden corporate policies to expose a “fraudulent marketing scheme” that he says the company used to promote Taxotere for off-label purposes and unlawfully gain funds from government programs.
During the period that Gohil worked for Sanofi, Taxotere was only FDA-approved for a few indications—second-line treatment of breast cancer and non-small cell lung cancer. Yet he says the company’s Oncology Sales division routinely promoted Taxotere use for over 15 other non-approved indications, as well as encouraging potentially unsafe, excessive dosages in order to sell more of the drug.
Gohil claims that a high volume of off-label sales was achieved through:
Whether or not Gohil’s allegations are true, Sanofi did receive multiple warnings from the FDA for distributing “misleading” print ads and other promotional materials for Taxotere.
In July 2001, the Division of Drug Marketing, Advertising, and Communications (DDMAC), the branch of the FDA that regulates marketing, sent a letter to Sanofi (named Aventis at the time) concerning a set of Taxotere brochures distributed at the company’s commercial booth during an annual meeting of the American Society of Clinical Oncology (ASCO).
These brochures, according to this first FDA letter, falsely advertised treatment with Taxotere and Adriamycin as “the only taxane combination approved for first-line treatment of metastatic or locally-advanced breast cancer.” This statement was untrue on two counts—
The FDA demanded that Sanofi “immediately cease the distribution of these and similar promotional materials.” But the company went on to receive a number of additional warnings in the following years:
Obviously, the possibility that Sanofi withheld an alopecia warning from the American public would appear consistent with earlier accusations of misleading marketing. For now, all we can make is an educated guess, as the whistleblower lawsuit and the growing list of patient lawsuits are still awaiting trial.
Unfortunately for prospective Taxotere users, probably not. The FDA generally only distributes urgent Safety Communications for potentially dangerous side effects. Because hair loss doesn’t pose a safety threat, the FDA will likely never issue such a warning about Taxotere-induced permanent alopecia, despite the negative impact the condition can have on patient well-being and quality of life.
However, the FDA did publish a safety warning about another potential side effect, and Taxotere recalls have been issued in Canada and more recently in Europe:
On June 20, 2014, the FDA alerted the public about alcohol levels in Taxotere, which may be high enough to cause intoxication. Doctors were urged to carefully consider the ethanol content in Taxotere (the alcohol dissolves the drug’s active ingredient, enabling intravenous administration), especially in the case of patients taking other medications that may have adverse interactions with alcohol. Patients were warned to wait for 1-2 hours after receiving a Taxotere infusion before performing tasks such as driving and operating machinery.
To help patients avoid this potential safety threat, manufacturers are in the process of developing an alcohol-free formulation of docetaxel.
Prompted by complaints from Finland and Sweden, Health Canada recalled a batch of Taxotere on October 30, 2006. According to the alert, the affected units may have been of a lower concentration than normal due to an error in filling solvent vials during production.
The European Medicines Agency announced on April 20, 2016, that Sanofi is recalling 15 batches of Taxotere due to a “software failure” at a Sanofi manufacturing plant in Germany that may have caused too much alcohol to evaporate, raising the concentration of the affected vials.
The EMA believes the recall may temporarily cause a Taxotere shortage in France, Ireland, Italy, and Spain, but supply is expected to return to normal on August 19, 2016.
Government of Canada: Recalls and Safety Alerts: Taxotere
Government of the United Kingdom: Taxotere Concentrate For Solution for Infusion Recall