Chemotherapy Drug Taxotere on Trial After Being Linked to Permanent Baldness
Though hair loss is a well-known side effect of chemotherapy drugs, more than 1,500 lawsuits have been filed against one cancer drug manufacturer that is being slammed for not advising its clients that the side effect of its product was likely permanent.
Taxotere, the brand-name of the drug docetaxel, was approved the U.S. Food and Drug Administration in 1996 to treat breast cancer. Since then, it’s also been expanded to include head and neck cancer, gastric cancer, prostate cancer, and non-small cell lung cancer. A reported side effect of the drug was hair loss, but plaintiffs say that the manufacturer knew the effect was permanent and did nothing to warn patients.
The manufacturer Sanofi-Aventis has said that permanent hair loss was a rare side effect. Vice President of Medical Affairs for Sanofi-Aventis Laurent-Didier Jacobs told Canadian newspaper The Globe and Mail, that “the side effect of persistent alopecia is suffered by about 3-percent of patients who take Taxotere with other chemotherapy drugs” and that it has been clearly listed on the product boxing since December 2006.
It’s that listing that plaintiffs take issue with.
Insufficient Warning on US Labels
A study conducted in 2005 at the National Institute of Cancer Research, showed that nearly 10 percent of those who used Taxotere suffered permanent hair loss. Defendant drug manufacturer Sanofi-Aventis demonstrated that they were aware of the results of this study when in 2005 this information was included on Taxotere labels in the European Union, and in 2012 when it was added to Taxotere labels in Canada. The US label, however, was not amended to explicitly warn of the associated risk of permanent alopecia until December of 2015, ten years after the information had been available to them.
Victims are not arguing that the drug was ineffective, but that the consequences were not explained ahead of time by the manufacturer.
“Unfortunately, the one side effect possibly most dreaded by the patient is alopecia. Yet, we have always told our female patients don’t worry, it will always come back. This last statement may not be true,” said the Colorado-based Rocky Mountain Cancer Center in a study they completed.
They found that 6.3-percent of patients who use Taxotere experience permanent hair loss.
“We fully understand that persistent alopecia may be a burden for patients, but still we consider it’s certainly something which is not life-threatening or is not something which impairs the likelihood of survival,” Dr. Jacobs said. “Taking into account the benefit brought by this type of therapy, we think things should be put in perspective.”
More Than Just Hair Loss
For patients going through cancer treatment, a recognizable indicator to the majority of the world that someone is going through the treatment – particularly for women – is hair loss.
Pamela Kirby of Oklahoma was treated with the drug in 2007 and notes the scar the drug has left on her.
“They absolutely told me my hair will grow back,” Kirby said in a Globe and Mail article. “I will never be well of breast cancer because of this. My life is not over, but my life is drastically changed.”
Taxotere on Trial
Cases against Taxotere started cropping up in January 2016 when an Ohio woman accused Sanofi-Aventis of concealing the devastating side effect from patients and doctors.
Allegations in the trials also claim that a competing drug Taxol is just as effective as Taxotere and does not have the risk of permanent alopecia, but that the drug makers promoted Taxotere as the more effective drug.
“Had Taxotere been the only option the women had perhaps they would have accepted the hair loss risk. However a 2008 New England Journal of Medicine study showed that Taxol was as effective as or more effective than Taxotere,” said news blog LawyersAndSettlements.com.
The case has grown since those initial filings all over the United States. They have since been folded into a multidistrict litigation case in federal court in Louisiana counting nearly 2,000 plaintiffs. Court proceedings will begin January 2019.
Plaintiffs hold that permanent hair loss can be a lasting scar from an otherwise successful battle over cancer, and they should have been warned of the consequences. Victims may be financially compensated should the Taxotere cases win against Sanofi-Aventis.