January 17, 2018 – San Diego, CA. Hundreds of thousands of women are diagnosed with breast cancer every year in the United States. A majority of those women will undergo chemotherapy to treat their cancer, accepting a well-known and common side effect of this treatment: temporary hair loss.
What many women did not know was that the temporary hair loss they were experiencing was not so temporary. The Food and Drug Administration (FDA) is now warning the most widely prescribed drug to treat breast cancer, Taxotere, can cause permanent hair loss in some patients. Many women speaking out against the drug say they would not have taken it had they known there was a risk of permanent hair loss.
What is alopecia and how is it associated with Taxotere?
Alopecia is a possible side effect reported by a number of women who were treated with Taxotere for breast cancer. Alopecia is a type of hair loss that occurs when the immune system attacks hair follicles, resulting in hair loss. Alopecia is usually not permanent; about 10 percent of people with the condition may never re-grow hair.
Hair loss is often associated with chemotherapy. However, the hair usually grows back once treatment has stopped.
Women who suffer from permanent alopecia after treatment with Taxotere may never re-grow their hair. Some women report the loss of their eyebrows and eyelashes, too. The makers of Taxotere estimate alopecia occurs in about three percent of patients, but some studies suggest that number is higher.
A study conducted by the Rocky Mountain Cancer Center in Colorado suggested about 6.3 percent of patients experienced alopecia when Taxotere was used in combination with other cancer-fighting drugs.
A survey conducted by the Clatterbridge Cancer Centre in the UK found 15.8 percent of respondents reported experiencing alopecia after using the generic version of Taxotere, docetaxel.
In December 2015, the FDA issued a warning about the possible risk of alopecia when undergoing treatment with Taxotere and its generic docetaxel. The FDA issued the warning in response to numerous adverse event reports submitted to the agency by patients and doctors.
We recently did a blog story on one woman’s struggle with Taxotere and hair loss, here is her story. https://www.nationalinjuryhelp.com/dangerous-drugs/taxotere-cancer-treatment-hair-loss/
Let’s find out more on this commonly used chemotherapy drug that can lead to hair loss (alopecia)
What is Taxotere?
Taxotere is the brand name of a chemotherapy drug used to treat certain cancers. The main ingredient in Taxotere is docetaxel.
Taxotere belongs to a class of chemotherapy drugs called taxanes. Taxotere, like other taxanes, are plant alkaloids derived from the bark of yew trees. Taxotere is also an anti-microtubule agent, which blocks cancer cells from dividing and eventually leads to cell death.
What is Taxotere used for?
Taxotere is indicated for the treatment of certain cancers. The chemotherapy drug is widely used to treat breast cancer, but is also approved to treat non-small cell lung cancer, advanced stomach cancer, head and neck cancer and metastatic prostate cancer.
The drug is also being tested for other uses, including in the treatment of small cell lung cancer, ovarian cancer, bladder cancer, and pancreatic cancer, as well as soft tissue sarcoma and melanoma.
When was Taxotere approved by the FDA?
The Food and Drug Administration (FDA) approved Taxotere roughly 20 years ago in May 1996. Taxotere was originally approved to treat certain types of breast cancer. Its use was later expanded to include treatment of certain lung, stomach, prostate and head and neck cancers.
Who makes Taxotere?
Taxotere is manufactured by French pharmaceutical company Sanofi-Aventis. The company’s American division, Sanofi US, is headquartered in Bridgewater, NJ and employs 17,000 people throughout the country.
How is Taxotere administered?
Taxotere is only available as an intravenous (IV) injection. Taxotere is administered in either 20mg/mL or 80mg/4mL single vial doses.
The drug’s label indicates Taxotere should be administered over a one-hour period every three weeks, though some research suggests Taxotere is most effective when administered in weekly doses.
All patients are advised to pre-medicate with oral corticosteroids before undergoing treatment with Taxotere.
Are there generic versions of Taxotere?
Yes. Generic versions of the drug were approved by the FDA in 2011. Generics are sold as docetaxel through several different pharmaceutical companies, including Accord Healthcare, Actavis Inc, Teva Pharmaceuticals USA and Dr. Reddy’s Laboratories Ltd.
Will my hair grow back after I stop treatment with Taxotere?
The majority of women will re-grow their hair after chemotherapy with Taxotere. On average, women who undergo chemotherapy with any drug will experience hair re-growth within a few weeks to a few months after ending treatment.
There is a percentage of women who may never re-grow their hair after treatment with Taxotere.
The makers of the drug estimate permanent hair loss occurs in about three percent of patients. Some studies estimate this percentage is much greater and could be anywhere from six percent to almost 16 percent.
Has the FDA issued any warnings about Taxotere?
The FDA has issued several warnings regarding Taxotere since the drug was approved 20 years ago.
Taxotere carries a “black box” warning, the FDA’s strongest warning about a drug or medical device. Black box warnings indicate there is a serious risk of hazard or even death associated with the product.
Taxotere’s black box holds several warnings for consumers and doctors including the risk of:
toxic death in patients with abnormal liver function
hepatoxicity in patients with high bilirubin concentrations
low white blood cell counts
hypersensitivity reactions and fluid retention
The FDA has also issued numerous safety communications in the past several years regarding Taxotere. Some of those warnings include the risk of:
renal (kidney) failure
respiratory problems, including failure
metabolism and nutrition disorders
How often is Taxotere prescribed?
About 1 in 8 women (about 12 percent) will develop invasive breast cancer in her lifetime. In 2016, it is estimated over 246,000 new cases of invasive breast cancer will be diagnosed, including an additional 61,000 new cases of non-invasive breast cancer, according to the American Cancer Society.
Taxotere is the most widely prescribed drug in its class to treat breast cancer. Up to 75 percent of breast cancer patients in the United States use Taxotere during their treatment.
Are there any lawsuits against the makers of Taxotere?
Yes. Breast cancer survivors have begun filing lawsuits against Sanofi-Aventis alleging the company hid potential side effects, including permanent alopecia, and misrepresented the drug’s benefits. The lawsuits have not been consolidated into a class action or multidistrict litigation at this time. Read more on Taxotere lawsuits here.