Chemotherapy Drug Taxotere Linked to Permanent Hair Loss
Our law firm has recently begun investigating claims for patients who underwent chemotherapy with the drug Taxotere (docetaxel) and developed permanent hair loss. Taxotere is a chemotherapy drug used in treatment of breast cancer and other types of cancers. It is alleged that the drug manufacturer (Sanofi-Aventis) knew about the risk of permanent hair loss, but failed to warn patients and physicians in the United States of this risk.
Taxotere underwent a FDA label revision in December 2015 to include a warning regarding the risk of permanent alopecia after a significant number of cases of permanent hair loss were reported to the FDA. However, it is alleged the drug manufacturer knew that Taxotere could cause permanent hair loss for approximately ten years, yet failed to warn patients and doctors in the United States about this risk. Until 2010, the manufacturer included a generic statement in the product label that hair generally grows back once treatment has been completed. After 2010, this statement was absent from the drug label and there was also no warning about permanent hair loss. Then, in December 2015, the product label was updated to include language advising doctors and patients that cases of permanent hair loss have been reported.
Taxotere and Warnings of Permanent Hair Loss Outside of the U.S.
As early as 2005, Sanofi-Aventis made a report to the European Medicines Agency that in 9.2% of patients alopecia persisted and was ongoing (median follow-up time of 10 years and 5 months). This means doctors and patients in Europe were warned about the potential for permanent hair loss. In Canada, a similar warning was issued in 2012 regarding the potential side effect of permanent hair loss after the use of Taxotere. Inexplicably, doctors and patients in the U.S. did not receive warnings of potential permanent alopecia until December 2015.
History of Taxanes
In pursuit of new cancer treatments, the United States government began researching plant based products. A molecule that was isolated form the Pacific Yew Tree in the early 1960s was named Taxol. It was discovered that Taxol can inhibit the activity or growth of cancer cells. Taxol is in a class of drugs known as Taxanes. Basically, Taxanes were found to stop cancer cells from reproducing. Taxol was developed commercially by Bristol-Myers and marketed under the brand name Paclitaxel. The FDA approved its use in 1994. Because the drug was patented, Sanofi-Aventis developed a semi-synthetic version in order to enter the market and that drug was named Taxotere.
Taxotere was approved by the FDA in 1996. As part of the marketing of this drug, Sanofi-Aventis noted that Taxotere was more potent than Paclitaxel and therefore more effective in treating cancer. Subsequent research in 2008 and 2009 confirmed that both the taxane-based treatments, Paclitaxel and Taxotere, were very similar in efficacy. As a result, in 2009, the FDA sent a warning letter demanding that Sanofi-Aventis cease using such claims in their marketing which suggested that use of Taxotere provided equal-to or superior results in treating cancer patients.
Taxotere Chemotherapy in Female Breast Cancer Patients
Typically, when deciding how to proceed with their treatment, a patient and her oncologist review the preferred protocols for treating her cancer as well as the pros and cons of each treatment regimen. Temporary hair loss is an expected side effect of many treatments, but even temporary hair loss can influence female patients in their choice of cancer treatment options. Given the choice between two equally effective chemotherapy drugs with one potentially causing permanent hair loss versus one that does not, it seems fairly obvious which drug many females would opt to choose and why.
Many women facing the diagnosis of breast cancer were denied the opportunity to choose their treatment course with the full knowledge of the possible side effect of permanent hair loss. This is the crux of this emerging litigation. If oncologists and patients had received warnings about the potential for permanent hair loss, then Taxotere may not have been the chemotherapy chosen for the treatment of their particular breast cancer. Many women who have survived breast cancer but are marked by permanent hair loss have joined a group called "Taxotears." You can read about the women survivors at aheadofourtime.org.
The litigation involving Taxotere is an emerging litigation in the United States. There has not been a recall of the drug, and only a few lawsuits have been filed. However, even though this is a new litigation, product liability statutes of limitation still apply. If you or a loved one have experienced permanent hair loss after being treated with Taxotere for breast cancer you should consult an attorney. It is possible that thousands of women have been negatively impacted after being treated with Taxotere.
Tampa Taxotere Attorneys
If you developed permanent hair loss after having chemotherapy with Taxotere and you wish to discuss whether you may have a legal claim, please contact Alley, Clark & Greiwe for a free consultation regarding your legal rights.
Consumer Information About Taxotere
Click here to read about the December 2015 label change
Click here to read the 2009 warning letter from the FDA to Sanofi-Aventis
Click here to read about the New England Journal of Medicine study from 2008
Click here to read the 2009 study published in the Journal of Clinical Oncology