Patients Suing Makers of Breast Cancer Drug Taxotere for Failing to Disclose Serious Side Effect of Permanent Hair Loss/Alopecia
Litigation is currently underway in California and elsewhere regarding the cancer drug Taxotere. The basis for the claims is that the pharmaceutical manufacturer withheld important information about the drug’s side effects from doctors and patients, keeping them from making an informed decision and resulting in serious harm from the drug’s effects. Read more about the Taxotere litigation below, or call Magaña, Cathcart & McCarthy at 310-553-6630 if you believe you were harmed by Taxotere and would like to speak with an attorney in a no-cost, confidential consultation.
What is Taxotere?
Taxotere (docetaxel) is a chemotherapy drug manufactured by the French drug company Sanofi-Aventis. Taxotere is approved by the FDA as a treatment for breast cancer and certain cancers of the lung, stomach, head, neck and prostate. Its purpose is to prevent cancer cells from growing and dividing. Taxotere is widely used in the treatment of breast cancer, and is in fact one of two major chemo drugs currently being used in breast cancer patients.
Like most chemotherapy drugs, Taxotere comes with a list of side effects ranging from mild to severe. It is important for cancer patients to know the possible side effects of a drug before consenting to its use. Sometimes more than one drug is available to fight the disease, and understanding the side effects is a major factor in the joint doctor-patient deliberation over the proper course of treatment to follow.
Permanent Hair Loss Reported in Nearly Ten Percent of Taxotere Users
Temporary hair loss is a not uncommon side effect of many chemotherapy treatments; chemo drugs target rapidly growing cells, which affect not only cancer cells but healthy hair cells as well. In most cases, hair growth returns after the course of chemotherapy is finished. However, in the case of Taxotere, it appears that hair loss or baldness, known as alopecia, occurs in 9.2% of the patients.
Sanofi Aware of Alopecia Side Effect for Years without Informing U.S. Doctors or Patients
Sanofi’s own report to the European Medicines Agency in 2005 showed alopecia persisting for years in 9.2% of Taxotere users. Yet as late as 2010, the drug maker’s US labeling included no warning of persistent or permanent hair loss but instead claimed, “Once you have completed all your treatments, hair generally grows back.” This last clause about hair growing back was removed from US labeling in 2010 through 2015, but there was still no mention of persistent or permanent hair loss. Only due to an order of the FDA, beginning in January of 2016, does Taxotere labeling now include information about hair loss and instruct that patients be counseled about this side effect. Specifically, the FDA requires that “Cases of permanent alopecia have been reported” be added to the list of adverse reactions on Taxotere labeling. This language still does not clearly inform of the probability that Taxotere will cause permanent hair loss.
Taxotere is LESS Effective than its Nearest Competitor
The other major chemotherapy drug prescribed for breast cancer patients is Taxol (paclitaxel), manufactured by Bristol-Myers Squibb. Taxol belongs to the same family of drugs as Taxotere and has been around longer than Taxotere. Taxotere, designed to compete with Taxol, is twice as potent as Taxol. Sanofi claimed that Taxotere’s increased potency made it more effective than Taxol, but a 2008 study reported in the New England Journal of Medicine found Taxotere to be slightly less effective than Taxol. In fact, in 2009 Sanofi was made by the FDA to stop marketing Taxotere as producing better results than Taxol. Another thing to know about Taxol is that it does not appear to cause permanent hair loss like Taxotere does.
Failing to Disclose Important Health Information is Unacceptable
The effects of alopecia on women undergoing treatment for breast cancer cannot be understated. In addition to physical disfigurement, female baldness can have a severe psychological effect and impact one’s sense of identity. Not only were patients not informed of this side effect and given the chance to make a knowledgeable informed decision, it appears that doctors and patients were actively misled for years. If doctors and their patients had known of the serious side effect present in Taxotere and absent in Taxol, along with the fact that the two drugs are equally effective, it is likely more women would have chosen Taxol, denying Sanofi-Aventis of some of the hundreds of millions in annual sales it has been reaping from Taxotere.
Act Now to Hold Taxotere Drug Makers Accountable for their Misdeeds
Multidistrict litigation (MDL) concerning Taxotere is currently underway in federal court in Louisiana, with “mini-MDL” cases currently active in Missouri and California state courts. If you believe you may have a claim against Sanofi-Aventis related to Taxotere, call Magaña, Cathcart & McCarthy at 310-553-6630 for a no-cost, confidential consultation to discuss your potential claims.