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If you were given Taxotere as part of your chemotherapy and now have permanent hair loss, you may be entitled to substantial financial compensation. Lawsuits are now being filed against the manufacturer, claiming the company failed to warn of this side effect. Contact an experienced Taxotere lawyer today to learn more about filing a lawsuit.
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Taxotere, a chemotherapy drug commonly used to treat breast cancer, has been linked to an increased risk for permanent hair loss, a condition known as alopecia.
While most, if not all, chemotherapy agents cause some degree of hair loss, the effect is usually temporary, with hair growth returning anywhere from three weeks to two months after the end of treatment. Taxotere’s effects, however, appear to be different. Recent research has found that more than 6% of women administered the drug may end up losing their hair forever. Risk estimates, gathered over the course of a decade, say anywhere from 3% to 15% of patients who receive Taxotere will experience permanent hair loss.
A growing body of critics say Sanofi, the manufacturer of Taxotere, has actively downplayed this risk, depriving patients and physicians of vital information. Several American women have already filed lawsuits against the company, and legal experts expect numerous additional claims to follow.
Taxotere is manufactured by Sanofi, a multi-national pharmaceutical corporation based in France. The drug’s active ingredient, docetaxel, is one of several chemicals in the taxane class. Most of these chemicals are used as chemotherapy agents, and the most notable alternative to Taxotere, paclitaxel, is sold by Bristol-Myers Squibb as Taxol.
Taxanes are derived from yew trees, and while synthetic versions have been created in the laboratory, the process is difficult due to their unique chemical structure.
Taxotere was first approved by the US Food & Drug Administration on May 14, 1996, and its approved indications have been expanded to include:
Taxotere is also approved as an adjuvant treatment for patients with operable node-positive breast cancer.
The drug is usually administered intravenously, either in a doctor’s office or out-patient clinic. Dosages will vary depending on a patient’s type of cancer, and the disease’s stage. As an adjuvant therapy for breast cancer, Taxotere is usually administered once every 3 weeks over the course of 18 weeks.
Mitosis is a fundamental step in cellular division, the phase in which a cell’s chromosomes separate into identical copies. Each copy, containing all the DNA that will guide the cell’s activity, eventually ends up in its own separate nuclei. Taxotere, like vinblastine and vinorelbine, is a mitotic inhibitor; the chemical stops mitosis from occurring. Thus it stops cancer cells, which have mutated and begun dividing uncontrollably, from growing further.
Taxotere steps in to disrupt the work of microtubules, spindly fibers that serve as a cell’s skeleton, providing structural support. During cellular division, microtubules help pull chromosomes apart for copying, and then arrange them in preparation for the cell’s division.
But to do this, microtubules have to be “dynamic,” growing longer and shorter to “feel” their way around the cell, like a person who is blind carefully steps through an unfamiliar hotel room.
Docetaxel prevents one part of this process: the microtubules can’t shorten themselves. Instead of breaking down, they build up. Soon the cell is so full of microtubules that it actually commits suicide, initiating a process called apoptosis, which ends in cellular death.
In sum, Taxotere takes a two-step approach to fighting cancer cells, inhibiting their ability to divide and ultimately forcing them to die. Paclitaxel works in a similar way. Most chemotherapy drugs, in contrast, alter the DNA or RNA of cancer cells, essentially ruining the instructions a cell would use to divide itself.
Medical evidence suggests that Taxotere can cause permanent, or persisting, alopecia in women who receive the drug as a treatment for breast cancer.
In 2006, Dr. Scot Sedlacek, a medical oncologist at Rocky Mountain Cancer Centers, performed a unique study. Sedlacek, a practicing physician, looked back at the breast cancer patients he had personally treated from January 1994 to December 2004. A total of 496 patients had received adjuvant chemotherapy:
Sedlacek’s goal was to find out how many of these women experienced persistent alopecia, or permanent hair loss, so he only included patients with at least one-year of follow-up. One-year, however, was an underestimation; the average patient had received their last dose of chemotherapy 2 years before the doctor’s follow-up, and some patients were reviewed more than 7 years after their last dose.
To Sedlacek’s surprise, none of the women who had been given doxorubicin alone, or doxorubicin and paclitaxel, reported “permanent scalp alopecia,” a condition he defined as “hair regrowth less than 50% of the pre-chemotherapy amount of hair as judged by both the patient and [Sedlacek].” But 7 women who had been administered docetaxel experienced permanent scalp alopecia. From his own data, Sedlacek concluded that the risk of developing permanent hair loss from Taxotere treatment may be as high as 6.3%.
Since Sedlacek conducted his 2006 study, multiple case reports have emerged, all describing women who experienced persistent alopecia after receiving Taxotere. More recent studies have found even higher risks, between 10% and 15% in one UK survey.
In their Taxotere lawsuits, women claim that Sanofi deceived patients, publishing marketing materials which led the medical community to believe that Taxotere, like other chemotherapy drugs, caused only temporary hair loss. But according to their allegations, the company was well aware, at least as early as 2005, that Taxotere could lead to persistent alopecia.
Until recently, the drug’s warning label mentioned nothing about how long a patient’s hair loss would last. It was only on December 11, 2015, at the urging of the US Food & Drug Administration, that Sanofi added the following statement to Taxotere’s labeling:
“cases of permanent alopecia have been reported.”
In Europe, however, Taxotere’s warning label has carried a statement to that effect since at least November 27, 2005. More than ten years ago, the European Medicines Agency, Europe’s FDA equivalent, noted under the drug’s “Post-Marketing Experience” section: “cases of persisting alopecia have been reported.”
In fact, the drug’s European label even notes that an early clinical trial found that less than 3% of patients experienced “alopecia (persisting).” No similar language was publicized in the United States until now.
Cancer, of course, is a life-threatening condition and, in the absence of a suitable alternative, most women would probably accept the risk of permanent alopecia in light of Taxotere’s benefits as a chemotherapy agent. But there is an alternative, paclitaxel.
Paclitaxel has been shown to be just as, if not more, effective than Taxotere. In 2011, for example, a group of Spanish researchers analyzed a wide array of medical studies, including 3 meta-analyses, which are themselves “studies of studies.” Their review included 16 randomized clinical trials, 1 systematic review and 5 clinical guidelines developed by practicing physicians, in addition to the 3 meta-analyses already mentioned. It was, in short, thorough and comprehensive. But the review’s conclusion was far from nuanced: “we found no evidence that regimens containing docetaxel yield greater benefits than those including paclitaxel.”
Current scientific evidence strongly suggests that paclitaxel does not cause permanent hair loss. Despite the two drugs’ comparable effectiveness, docetaxel is twice as potent a chemical, and may be twice as toxic. With such an effective, and potentially safer, alternative available, critics have started to wonder why anyone was prescribed Taxotere in the first place. Those questions have only grown more pointed now that the drug’s link to permanent alopecia, a condition that can have distressing psychological and social effects, is becoming clearer.
Yes.
Sanofi lost its patent on docetaxel in 2011. Currently, as many as 7 generic equivalents are available, but at least one of these generics is manufactured by Winthrop Pharmaceuticals, a subsidiary of Sanofi. Reports indicate that around 60% of all docetaxel prescriptions are written for the brand name drug.
Taxotere is often combined with cyclophosphamide, another chemotherapy drug, in a regimen often shortened to TC chemotherapy.
Beyond a likely increased risk of permanent hair loss, which Dr. Scot Sedlacek calls “the one side effect possibly most dreaded by the patient,” Taxotere can cause alterations in the body’s immune system, specifically:
White blood cells, of course, are essential in your body’s efforts to fight off illness, and Taxotere may increase the risk of infection. Severe thrombocytopenia, a low blood platelet count, is another common side effect. It can lead to bleeding in body tissues, bruising and inhibited clotting.
Nausea, vomiting, and fever, along with general weakness and pain, are also frequently reported by patients receiving Taxotere. Some patients will gain weight, while others will experience a swelling in the stomach, face, hands or lower limbs.
