Sanofi Faces French Scrutiny and Investigation Over Taxotere Deaths


    A popular chemo drug from French manufacturer Sanofi is under fire in the European Union over unexpected patient deaths. Doctors regularly prescribe Taxotere in both the United States and Europe to fight breast cancer. But last year, the European Medicines Agency (EMA) ordered a new safety review for all generic Taxotere doses distributed in France. This came after five patients infused with the drug died from neutropenic enterocolitis in less than six months. And though this particular Taxotere side effect is rare, it’s also deadly. Sanofi, Taxotere’s manufacturer, now faces examination from the French National Drug and Health Product Safety Agency (ANSM) over safety practices. But public scrutiny over controversial drug safety issues is nothing new to Sanofi. In February 2018, a Phillippine government agency sued Sanofi after a 10-year-old girl injected with the company’s Dengvaxia vaccine died.

    French Oncologists Switch to Taxol During Sanofi Investigation

    Permanent hair loss is still Taxotere’s most notorious and controversial side effect risk. But neutropenic enterocolitis, which is very hard to detect, is also possible. Neutropenic enterocolitis inflames the mucosal lining inside your small intestine and colon. This inflammation can cause perforation injuries and severe infection. Many breast cancer patients experience diarrhea and pseudomembranous colitis after starting chemo treatment. But all taxanes — e.g., Taxotere and Taxol’s drug class — can cause severe inflammatory changes in colonic mucosa. This can turn your colon into a breeding ground for harmful bacteria, such as C-Diff and exotoxins.

    All five French patients that died received Taxotere’s generic formulation (called docetaxel) ranged from 46 to 73 years old. Despite unusually high adverse effect reports, ANSM did not ask Sanofi to suspend its Taxotere marketing efforts in the EU. After the first three deaths, the ANSM launched an investigation to test all available docetaxel and Taxotere batches for contamination. During the investigation, the Institut Curie and other healthcare facilities switched to generic Taxol (paclitaxel) for treating breast cancer patients.

    After the EMA concluded its Taxotere and docetaxel investigation, the agency found no increased drug safety risks. “Neutropenic enterocolitis remains a rare side effect,” said the EMA’s Pharmacovigilance Risk Assessment Committee in its June 2017 statement. According to the panel’s investigation, about one in a thousand docetaxel or Taxotere patients will develop neutropenic enterocolitis. However, the Institut Curie in Paris still uses generic Taxol (paclitaxel) to treat breast cancer patients today.

    Measuring NE Risk for Breast Cancer Patients

    Studies show that patients who develop neutropenic enterocolitis (NE) with Taxotere use have a 30-50% mortality rate. And it doesn’t take long for affected breast cancer patients to exhibit this complication. Many chemo side effects can take months or even years to show up and cause lasting damage to patients’ health. However, patients are most at risk for developing NE within 10-14 days after treatment with docetaxel or Taxotere.

    And while early warning signs may help patients identify NE quickly and increase survival rates, it’s not guaranteed. No medical studies suggest that early intervention can reverse well-established NE cases. Still, there are warning signs that Taxotere or docetaxel patients should report to their doctor immediately, including:

    • Nausea
    • Vomiting
    • Fever
    • Right lower quadrant abdominal pain
    • Abdominal distention (bloating just below your stomach)
    • Watery or bloody diarrhea

    If you have three or more symptoms, ask your doctor to test your white blood cell count. Your doctor can also perform a CT scan to identify any issues. Taxane-based regimens like Taxotere and Taxol may alter your bowel function, but it doesn’t always indicate NE. Antibiotic therapy may be able to treat NE cases after early detection, but more aggressive treatments (like surgery) are standard. That’s because bowel perforations can cause internal bleeding and septic infections that spread quickly to other internal organs and tissue.

    Other Potentially Serious Taxotere/Docetaxel Side Effects

    NE is a serious condition that mostly affects immunocompromised patients, especially those undergoing breast cancer chemotherapy. But it’s not the only risk associated with Taxotere or docetaxel. Sanofi is currently conducting clinical trials in an attempt to expand Taxotere’s approved uses. Right now, Sanofi only has FDA approval for Taxotere to treat:

    • Breast cancer
    • Non-small cell lung cancer
    • Advanced stomach cancer
    • Head and neck cancer
    • Metastatic prostate cancer

    However, Sanofi is currently conducting Taxotere clinical trials hoping to gain FDA approval for treating:

    • Small cell lung cancer
    • Ovarian cancer
    • Bladder cancer
    • Pancreatic cancer
    • Soft-tissue sarcoma
    • Melanoma

    The market for Sanofi’s cancer drug keeps growing — despite studies showing Taxotere’s harmful effects. This makes it more important than ever for patients to educate themselves about Taxotere’s dangers.

    Most chemo side effects are temporary and stop within 6-8 weeks after treatment ends. Unfortunately, Taxotere is linked to permanent and irreversible hair loss (persistent alopecia). Colorado’s Rocky Mountain Cancer Center published a 2006 study showing permanent hair loss affected up to 6.3% of Taxotere patients.

    Another study estimates that closer to 15.8% suffered persistent hair loss after treatment with Taxotere.

    Peripheral neuropathy is another serious Taxotere complication. Many patients experience numbness in fingers and toes due to chemo-induced nerve damage. But it’s the pain during chemo that most patients dread. One study reports that nerve pain was the most “severe and distressing symptom in persons receiving docetaxel.” Long-term nerve damage can cause pain, loss of feeling and other sensory issues.

    Taxol May Be Cheaper, More Effective for Breast Cancer

    If Taxotere was the only taxane drug available to treat breast cancer, patients could probably overlook the permanent alopecia risk. After all, chemotherapy provides life-saving benefits, and doctors treat 75% of breast cancer patients with Taxotere or docetaxel. But studies show that Taxol (paclitaxel), Taxotere’s closest competitor, does not cause permanent hair loss. In fact, Taxol may actually be more effective for treating breast cancer than Taxotere. But here’s something patients should know: The price Sanofi charges for docetaxel is 10x more expensive than paclitaxel.

    FDA Warns Sanofi Over Illegal Marketing Practices

    Sanofi hopes to expand their current U.S. market share for Taxotere. But they’ve been in trouble with the FDA before over illegal marketing. In 2009, the FDA sent a warning letter to Sanofi about misleading Taxotere marketing claims. Among other things, the FDA alleged that Sanofi overstated Taxotere’s benefits and downplayed risks in public-facing ad campaigns. They also said Sanofi marketed Taxotere as superior to paclitaxel without enough evidence to support those claims.

    How to Check Your Eligibility for Compensation From Sanofi

    As Sanofi looks to increase Taxotere sales in America and Europe, more injured consumers are filing lawsuits. The Taxotere MDL currently holds over 1,200 product liability and failure to warn claims against Sanofi. Did you or someone you love experience hair loss for six months or longer after completing Taxotere or docetaxel chemo? If so, then you may qualify for a cash settlement from the drug’s maker, Sanofi. To check your eligibility for compensation, complete your free Taxotere claim evaluation today. You’ll see your results in just minutes! After submitting your information, an experienced Taxotere lawyer will call to help you get the justice and compensation you deserve.

    Related: Breast Cancer Chemo Side Effects: What to Expect

    Mandy Voisin

    Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.

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