Taxotere

Studies + Science

Taxotere is a highly powerful chemotherapy drug. It's about two times as potent as another chemo drug called paclitaxel, and at least five times more potent against paclitaxel-resistant cells.

Studies show that Taxotere, which is used by double the amount of women, can improve survival in the fight against metastatic breast cancer. Though permanent hair loss may be more difficult for females, no one working to overcome the debilitating side effects of chemotherapy needs additional hurdles.

How does Taxotere work?

Cancer cells spread disease through continuous division and multiplication. During the division process, Taxotere targets harmful cell structures called microtubules. The drug stops them from dividing and spreading the DNA that creates tumors.

Taxotere is a semi-synthetic, second-generation member of a plant alkaloid drug class called taxanes. Taxanes are derived from the European Pacific Yew tree, also known as the taxus. Studies show Taxotere is more likely to aid in the survival of cancer patients, compared to other chemotherapy injections.

According to Cancer.gov, Taxotere treats five types of cancer:

• Breast cancer that is locally advanced or has metastasized (spread to other parts of the body) and has not lessened with other chemotherapy. It is also used to treat breast cancer that is node-positive and can be removed by surgery.
• Advanced adenocarcinoma of the stomach or gastroesophageal junction. It is used in patients who have not been treated with chemotherapy for advanced disease.
• Non-small cell lung cancer in certain patients whose cancer is locally advanced or has metastasized.
• Prostate cancer that has metastasized in men whose cancer is hormone-refractory (does not respond to hormone treatment).
• Squamous cell carcinoma of the head and neck that is locally advanced and cannot be treated with surgery.

What is alopecia?

Alopecia is an autoimmune disease that results in permanent hair loss when the body attacks its hair follicles. When triggered by Taxotere, alopecia often starts as a single bald spot. Over time, the loss will stretch into patches that spread across the scalp and body. Sometimes round areas of baldness may overlap. No part is spared, and in many cases, even eyelashes and eyebrows will disappear.

In 2005, the GEICAM 9805 study, funded by the drug manufacturer Sanofi, found that 9.2 percent of patients suffered hair loss for at least a decade. In 2012, a Rocky Mountain Cancer study found that 6 percent of women will develop alopecia. That same year, the Annals of Oncology published a study that showed 19 of 20 women who used Taxotere suffered from irreversible hair loss.

Although alopecia is a long-lasting side effect, people using Taxotere can also experience a number of other adverse effects.

Regulation Recap

The FDA approved Taxotere in 1995 for metastatic breast cancer, and it has since become one of the most widely used breast cancer medications.

FDA Acts on Taxotere Side Effects

In 2006, the FDA included a black box warning to Taxotere, the highest level of consumer caution. The warning informed patients about the danger of:

• Toxic death
• Hepatoxicity (kidney damage)
• Hypersensitivity reactions (rash, low blood pressure, and fatal anaphylaxis)
• Fluid retention

Later, on June 20, 2014, the FDA also noted that driving while using Taxotere treatments is highly dangerous because of the drug’s ethanol content. Patients shouldn’t drive for at least two hours. The agency reminds people using Taxotere to discuss mixing alcohol and other medications with a doctor.

Two breast cancer patients overdosed, and though neither instances were fatal, it’s important to approach the treatment with caution. Symptoms of overdose include a sore throat, fever, chills, and other signs of infection, sores in the mouth and throat, skin irritation, weakness, numbness, tingling, or burning sensation in the hands or feet.

Sanofi discovered the risk of alopecia in 2005 and updated the Taxotere's warning label to reflect that risk of alopecia in Europe. Alopecia was added to Canada's warning labeling in 2012, but the United States labeling wasn't updated to include permanent hair loss until December 2015. Lawsuits allege that the company intentionally hid the risk to generate higher profits.

Legal Battles

Women who developed permanent hair loss from Taxotere have begun to speak out against Sanofi, which dramatically increased its sales revenue from $424 million in 2000 to $1.4 billion in 2004.

One lawsuit in particular, the case of Ami Dodson, has drawn attention to the drug and its manufacturer. Dodson was diagnosed with breast cancer in March 2010. She underwent a partial mastectomy and was treated with Taxotere.

Dodson, who wasn't informed of the baldness risks, developed alopecia. Her lawsuit has drawn attention to the drug's side effects, empowering others to stand up for what's right.

A number of lawsuits are being filed against Sanofi. The plaintiffs allege that the manufacturer failed on a number of occasions, including:

• Failure to inform patients about irreversible hair loss
• Failure to publicize research proving linking alopecia to Taxotere
• Failure to guide patients in how to limit the likelihood of alopecia

Sanofi-Aventis had previously faced another lawsuit. A Qui Tam civil case was focused on an employee who accused Sanofi-Aventis and its affiliates of "engaging in a fraudulent marketing scheme, paying kickbacks, and providing other unlawful incentives to entice physicians to use Taxotere."

The Dodson complaint represents thousands who were affected by the manufacturer's "wrongful conduct" and exposed to Taxotere when other less toxic drugs were available. The lawsuit alleges that Sanofi prayed on vulnerable groups at a difficult time, which led to billions in sales "at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.”

On Sept. 26, 2019, the first Taxotere trial from over 11,000 lawsuits in a Multidistrict Litigation (MDL) against multiple pharmaceutical companies, concluded with the jury clearing Sanofi of all charges. Though the jury did not side with one plaintiff, thousands more will either settle or go to trial in the coming years.

The Next Steps

Changes in appearance from Taxotere affect overall quality of life. Many women affected by Taxotere would have pursued other options had they known about the alopecia side effect.

Anyone using Taxotere should be made aware of drug's side effects. If you weren't told about the hair loss risk, we're here to help.