Side effects such as temporary hair loss have long been associated with chemotherapy. Along with nausea and fatigue, hair loss is among the most well-known side effects of chemotherapy drugs. Cancer patients endure the inconvenience of losing their hair because of the belief that the drugs will eventually help them beat cancer; they also do it because of the knowledge that such hair loss is only temporary, and that it will regrow once cancer treatment is finished.
Unfortunately, however, when it comes to treating breast cancer patients in the U.S., an increasingly large number of lawsuits are being filed against the makers of Taxotere® (docetaxel), alleging that the Big Pharma company withheld crucial internal knowledge, and subsequent public warnings, that Taxotere-related hair loss could, in fact, potentially become permanent, due to the drug causing total destruction of one’s hair follicles.
Taxotere®-Related Hair Loss
Consumer lawsuits allege that the drug makers, Sanofi-Aventis, a $115 Billion-dollar company headquartered in Paris, France, actively encouraged doctors to use Taxotere despite its risks and the availability of other, potentially safer chemotherapy treatment regimens.
Sanofi’s marketing strategies may have misled prescribers into believing that their drug was stronger and more effective than alternatives. In truth, medical professionals did not have the complete picture, and were lacking key information that would’ve helped them make a more well-informed decision. Medical professionals and patients alike were unaware that using the chemotherapy drug could result in permanent baldness.
In fact, Sanofi’s own internal studies indicated a 10 percent chance that Taxotere users could experience permanent baldness. To reflect this knowledge, labels for the drug were changed in both Canada (in 2005) and Europe (in 2012) to reflect a risk for permanent significant alopecia (PSA), or permanent baldness – but such a label change did not occur in the U.S.
Taxotere® Hair Loss Controversy
Sanofi’s Taxotere® was born out of the competition between 2 Pharma giants for large shares of the anti-cancer drug market. In the mid-90s, the drug Taxol®, manufactured by Bristol-Myers Squibb (BMS), was incredibly successful from a sales standpoint. To compete with BMS, Sanofi introduced their drug, Taxotere®, hoping to compete for the market share.
Taxotere first received U.S. Food and Drug Administration (FDA) approval in 1996 and since has gained a substantial foothold, raking in well over $200 Million in annual sales. Currently, it is approved to treat breast, stomach, head and neck, non-small cell lung, and prostate cancers.
The drug Taxotere, and its competitor Taxol, come from the same family – the taxenes – though Taxol is derived from the bark of the Pacific Yew tree and Taxotere is synthetic. Both drugs work similarly, by fighting cancer through inhibiting the growth and proliferation of new cancer cells.
While, side-by-side, the 2 drugs may seem similar, Sanofi markets its drug to patients and healthcare providers as being a stronger, more potent and more effective version of Taxol – but this hasn’t been verified by medical experts. Rather, there are some studies that suggest the opposite: that Taxotere is not as effective in killing cancer cells.
Taxotere® Lawsuits Mount over Disfigurement, Loss of Work, and Mental Anguish
Lawsuits allege that neither patients nor their medical teams knew that Taxotere was associated with permanent baldness. As a result, women have suffered irreversible disfigurement from their using a medication that they thought would save their lives. For them, their hair will never grow back.
Lawsuits are also pointing to recent U.S. drug-label changes that occurred in 2015, which, ultimately, were not substantial enough. While the labels warn of “alopecia”, the warning is vague. The entire point of providing accurate warning labels is to allow consumers to make the most well-informed decision possible, given all of the variables. Unfortunately, this is not a choice that Taxotere users, nor their prescribers had.
Lawsuits, which are being filed around the U.S. – the latest of which is in Mississippi – present claims against Sanofi-Aventis that the company acted in negligence, failure to warn, breach of warranty, fraud, and misrepresentation, among others.
In other, recent news (June 10th), Sanofi-Aventis recalled a large batch of Taxotere in Europe for reportedly being too strong by 5 percent — further proving that Taxotere, and its maker Sanofi, continue to be no stranger to controversy.