Being diagnosed with cancer is an unimaginable feeling. Unfortunately, the American Cancer Society1 estimates more than 1.5 million new cases of cancer are diagnosed each year.
Although cancer is the second leading cause of death in the United States, there are more than 15 million cancer survivors currently living in the United States. Treatment options are available, but they can be painful, draining, and leave people physically transformed.
Most people can live normal and healthy lives after battling cancer with chemotherapy. However, a growing number of patients are experiencing permanent changes as a result of a drug called Taxotere.
Cancer survivors are claiming that using Taxotere has caused permanent and unexpected hair loss. Now victims are taking the makers of Taxotere to court for failing to warn patients of unexpected side effects, misleading the public with false advertising, and making a dangerous drug.
Taxotere is a chemotherapy drug that interferes with a cancer cell’s most basic functions.2
Sometimes known as docetaxel, Taxotere is injected into a vein using an IV once every three weeks to inhibit a cell’s mitosis function. By interfering with cell division and replication, Taxotere helps to control and stop the spread of cancerous cells.
The drug was first approved by the U.S. Food and Drug Administration back in 1999 to treat non-small cell lung cancer. It was later approved by FDA for treatment in prostate cancer and breast cancer in 2004. The drug also received approval for use in the treatment of stomach, head, and neck cancers in 2006. It is manufactured and marketed by Sanofi-Aventis.
Taxotere is currently one of the most popular drugs used to treat breast cancer. However, it is also sometimes used during treatment for cancers of the lung, stomach, head, neck, and prostate.
Like many chemotherapy drugs, Taxotere has side effects. According to the prescribing information sheet3 for Taxotere, the most common side effects include (but not limited to):
The prescribing information sheet also warns of potentially serious side effects associated with Taxotere, such as acute myeloid leukemia, blood disorders, skin reactions, neurologic symptoms, vision problems, intoxication, and death.
Hair loss is a common side effect of chemotherapy treatments. However, the hair usually grows back after treatment ceases.
Some patients taking Taxotere have reported that their hair loss became permanent, a condition known as alopecia. Several studies have backed up these claims.
One study in 2006 conducted by the Rocky Mountain Cancer Center found 6.3% of women taking Taxotere for breast cancer had suffered long-term hair loss described as “male pattern baldness.”
Another study published in March 2011 noticed five out of the seven chemotherapy-induced cases of alopecia from a pool of more than 8,000 had been treated with Taxotere.4
In a 2012 prospective study of 20 breast cancer chemotherapy patients with alopecia, researchers concluded: “Permanent and severe alopecia is a newly reported complication of the FEC 100–docetaxel breast cancer regimen.”
Undergoing treatment and surviving breast cancer is a harrowing experience for most women. But the permanent loss of hair following treatment can be even more devastating.
Even in 2006, researchers were warning about the potential damage of alopecia from Taxotere. “Such an emotionally devastating long term toxicity from this combination must be taken into account when deciding on adjuvant chemotherapy programs in women who likely will be cured of their breast cancer,” one researcher wrote.
In one study, women who have suffered permanent hair loss from Taxotere claimed there was a “severe impairment” in their quality of life. Most wore wigs to hide the alopecia.
This life-altering side effect led thousands of breast cancer survivors and their families to file lawsuits against Sanofi-Aventis.
In the lawsuits, women claim that the manufacturer knew the drug could cause alopecia but failed to warn healthcare professionals or patients of the risk. Patients have also accused Sanofi-Aventis of false marketing.
It wasn’t until December 2015 when the FDA ordered the company to update the warning label to include the risk of permanent hair loss did more women become aware of possible side effects.
Even after studies and experts pointed to the risks, Sanofi-Aventis insisted there was insufficient evidence. Before being revised, Taxotere’s prescription information sheet5 stated that once chemotherapy is finished, “hair generally grows back.” While this is true for the majority of women treated with Taxotere, some women will have to deal with the side effects for the rest of their lives.
Because of Sanofi-Aventis’ failure to warn patients of the risks, users of Taxotere who suffer from permanent alopecia may have the right to get compensation for their emotional and physical damage.
So far there has been no global settlement to resolve the thousands of cases still pending in courts in the United States. However, legal experts say the likelihood of a settlement is increasing. But for a settlement to be reached, several lawsuits may have to go to trial as test cases.
These act as bellwether trials and provide a clearer picture on both sides about the strength of the cases. If the jury verdicts go in favor of plaintiffs, Sanofi-Aventis will be more likely to settle cases out of court.
Judge Kurt D. Engelhardt of the United States District Court for the Eastern District of Louisiana, where Taxotere cases have been consolidated into multidistrict litigation, has scheduled the first of the bellwether trials for September 2018. Four additional trials are slated for 2019.
Although hair loss can feel be a crippling and isolating experience, it is not out of the ordinary among cancer survivors.
The American Cancer Society6 has programs to help those with cancer manage their lives through treatment and recovery. Support groups are a wonderful way for women to regain self-esteem and confide in other women who have been through similar struggles.
Those who have suffered permanent hair loss after receiving Taxotere are encouraged to contact a qualified attorney for legal advice.
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