Taxotere Side Effects from Breast Cancer Chemotherapy

Baseluos Law Firm is currently assisting plaintiffs throughout the country to recover injuries sustained by women with breast cancer who underwent chemotherapy and suffered permanent alopecia (hair loss) from taxotere. Lawsuits are currently being filed against the makers of taxotere, Sanofi Aventis, in connection with the design, development, and marketing of this cancer prescription.  Taxotere, part of the drug family known as taxanes, is used in the chemotherapy treatment of various cancers, with a primary emphasis on breast cancer. The taxanes are part of a family of chemical components known as diterpenes produced naturally from plants.

Bristol Myer Squibbs manufactures paclitaxel (taxol) , the major competitor to taxotere.  However, Sanofi designed taxotere as a highly potent taxane alternative to its rival taxol. Since 1989, Sanofi through its subsidiary Aventis controlled and developed all patents related to taxotere. Sanofi enrolled patients in clinical testing trials beginning in 1990. This fact is critical because Sanofi is alleged to have withheld information and data from those tests from doctors (especially oncologists), patients, and the FDA. It should be noted that in 1994, the FDA’s Oncologic Drugs Advisory Committee panel unanimously recommended the rejection of taxotere, because the drug was deemed to be much more toxic than Bristol’s taxol, which had previously received FDA approval. The FDA recommended more testing on the side effects of docetaxel , the chemical name for taxotere. In May 1996, FDA finally approved taxotere, limiting use of taxotere to treat advanced or metastatic breast cancer after failure of prior chemotherapy.

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After the initial FDA approval, Sanofi sought approval for expanded applications of taxotere. Specifically, Sanofi and its subsidiaries now claimed their drug was a more effective chemotherapy drug against breast cancer. Specifically, they now claimed taxotere was more effective than its rival taxol, and they reiterated such misleading comparisons in their marketing. Today, post market surveillance has shown Sanofi’s claims of superior efficacy to be fraudulent. A 2008 study in the New England Journal of Medicine measured the efficacy of taxol and taxotere and concluded that taxol was a more effective chemotherapy drug than taxotere. Despite overwhelming statements in a reputable medical journal, Sanofi continued to proclaim taxotere’s superiority. Their actions led to a stern warning letter from the FDA in 2009 in which the FDA cited Sanofi’s unsubstantiated superiority claims and overstatement of the efficacy of Taxotere. The FDA  found Sanofi Aventis in violation of the Federal Food, Drug, and Cosmetic Act.

Today, Michael Baseluos is a taxotere lawyer actively pursuing cases for taxotere victims who have suffered permanent and disfiguring hair loss in women. Breast cancer patients with alopecia after undergoing chemotherapy with taxotere are eligible for compensation. Sanofi Aventis failed to issue previously undisclosed warnings until December 2015.  The original taxotere warning labels misled breast cancer survivors into believing they would recover their hair loss, when in fact there is permanent alopecia from taxotere.  The FDA forced Sanofi to update their label to reflect the side effect of permanent alopecia after chemotherapy treatment.  Since its first clinical trials, there is deep suspicion that Sanofi has know for almost two (2) decades about taxotere causing permanent hair loss. A little known fact is that Sanofi updated its warning labels of cancer treatment hair loss in Europe in 2005 and in Canada in 2012. Those same warnings were not revealed to US customers until December 2015. Taxotere Permanent Hair Loss (Alopecia) cases are now part of Multi District Litigation (MDL) in the US District Court, Eastern District of Louisiana assigned to Judge Englehardt, Chief Judge of the Eastern District of Lousiana.

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