The Taxotere lawsuit claims the manufacturer of Taxotere (Sanofi-Aventis) failed to warn patients and physicians of the increased risks of permanent alopecia (loss of hair).
What Do We Know About the Taxotere Lawsuits?
Claims are being filed against Sanofi-Aventis by women who have suffered permanent hair loss as a result of being prescribed Taxotere. Attorneys state that if the manufacturer had properly warned of the risks, patients would have been prescribed a different chemotherapy drug called Taxol, which is more effective than Taxotere, and does not result in permanent hair loss.All cases filed in federal court have been consolidated before one federal judge in New Orleans under a process known as multi-district litigation. Our law firm has been appointed by the judge as a member of the Plaintiffs' settlement committee.
What are the Allegations in the Taxotere Litigation
- Taxotere is defective and unreasonably dangerous;
- Sanofi-Aventis was negligent in the manufacturing of Taxotere;
- Sanofi-Aventis failed to properly test Taxotere, and failed to warn doctors and patients of the potential for alopecia; and
- Sanofi-Aventis concealed evidence of the dangers of Taxotere, and misrepresented the effectiveness and safety of it in its marketing material.
What is the Purpose of Taxotere
Taxotere (docetaxel) is a chemotherapy drug approved in the treatment of breast cancer, non-small cell lung cancer, advanced stomach cancer, head and neck cancer and metastatic prostate cancer. It is administered intravenously through a vein, and is member of a family of drugs called taxanes. It is used to try to prevent cancer cells from growing and dividing.
Taxotere is normally used in combination with other drugs such as capecitabine, cisplatin, fluorouracil, doxorubicin and cyclophosphamide to fight off cancer and provide patients with better survival rates. It acts as an anti-mitotic agent, meaning that it disrupts cellular division. It is usually administered intravenously during one hour-long infusion cycles that are then repeated every 3-4 weeks.
Taxotere Injuries & Side Effects
The most serious potential side effect from Taxotere is neutropenic enterocolitis, which is inflammation of a small pouch located at the head of the large intestine. Although the condition is rare, it can be fatal.
Another potentially devastating side effect is permanent alopecia (loss of hair).
|Common Side Effects|
|Bone, muscle or joint pain|
|Fatigue and weakness|
|Fluid retention with weight gain, swelling of the ankles or abdominal area|
|Low red blood cell count (anemia)|
|Low white blood cell count|
|Mouth or throat sores|
|Nail changes (color changes to your fingernails or toenails)|
|Peripheral neuropathy (numbness in your fingers and toes)|
When Sanofi-Aventis began marketing Taxotere, it advertised the drug as more effective than its competitor drug Paclitaxel (known as, Taxol and Onxol). However, Taxotere is significantly more dangerous and linked to a greater number of potential side effects.
Additionally, Paclitaxel can be used at lower doses with similar effects, leading to less severe adverse reactions, and is cheaper than Taxotere.
A study published in Cancer Treatment Reviews compared the safety and effectiveness of Taxotere and Paclitaxel. Taxotere produced no greater benefits over Paclitaxel, and often led to drug resistance, requiring the treating physicians to prescribe higher, more toxic doses.
My oncologist prescribed me a cocktail of chemotherapy drugs, one of which, Taxotere, can cause permanent baldness in some women who have the treatment. That wasn’t explained to me fully at the time. If I had known the side effects, would I have refused the drug? Absolutely. There is another drug, Taxol, which is as effective and the risk of permanent hair loss is negligible. Instead, today, I am almost bald. To read more, click The MirrorI survived cancer - but drugs left me with permanent alopecia:
Shirley’s hair loss during chemotherapy turned out to be 'Alopecia - Persistent Significant' – and permanent. . . . The cause was a drug called Taxotere (Docetaxel), which, when combined into a “cocktail with other chemotherapy drugs”, causes "male pattern baldness". To read more, click The TelegraphWomen who took chemo drug say they weren't warned of permanent hair loss:
This lasting side effect of the chemotherapy drug Taxotere, in combination with other drugs, came to light when cancer patients began living longer. These women are now finding that survival comes at a cost. Balding women from Canada, the United States, the United Kingdom and France are calling themselves the Taxotears. To read more, click The Globe and Mail
For additional news stories, click Levin Law Taxotere News
FDA and Scientific Studies Regarding Taxotere
Taxotere (docetaxel) injection concentrateFDA approves following language to Taxotere label: “Cases of permanent alopecia have been reported.” To read more, click FDA Drug Safety Information
Permanent scalp alopecia related to breast cancer chemotherapy: a prospective study of 20 patientsTwenty white Caucasian females were included. Hair loss presented with a moderate or intense androgenetic-like pattern of scalp alopecia. Biopsy specimen examinations were normal or displayed the androgenetic-like pattern. Laboratory explorations ruled out iron or zinc deficiency and thyroid disorders and confirmed hormonal menopause without hyperandrogenism. The overall mean DLQI score reflected the distressing psychological consequences in the patients' lives. No spontaneous regrowth of the scalp hair was noted. Treatment including vitamins, minoxidil, psoralen and ultraviolet A therapy and spironolactone proved to be ineffective. Permanent and severe alopecia is a newly reported complication of the FEC 100-docetaxel breast cancer regimen. To read more, click Annals of Oncology
Long Term Hair Loss in Patients with Early Breast Cancer Receiving Docetaxel Chemotherapy: Long term significant scalp alopecia (here lasting for up to 3.5 years following completion of chemotherapy) may affect 10-15% of patients following docetaxel for EBC. This appears to be unrelated to other patient and treatment characteristics. Long term hair loss has a significant impact on quality of survival. Further prospective study is required to confirm incidence and to identify effective preventive and management strategies. This risk should be discussed routinely (as part of the process of informed consent) with all patients embarking upon docetaxel as a component of management of EBC. To read more, click NCRI Cancer Conference
A Head of Our Time: Living with Persistent Chemo-Induced Alopecia:According to Sanofi-Aventis, manufacturer of the chemotherapy drug Taxotere—used to treat breast, lung, gastric, head and neck and prostate cancer—3% of patients administered the drug could experience long-term alopecia. This figure could rise to as high as 6.3% when given in combination with the drugs Adriamycin (doxorubicin) and Cyclophosphamide, according to a study by the Rocky Mountain Cancer Centers in Colorado. To read more, click A Head of Our Time