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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.
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What Is Taxotere?
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:
- locally advanced or metastatic breast cancer (after failure of previous chemotherapy regimens)
- locally advanced or metastatic non-small cell lung cancer (after failure of platinum-based chemotherapy)
- androgen independent (hormone refractory) metastatic prostate cancer (in combination with prednisone)
- previously-untreated, but advanced, gastric adenocarcinoma (in combination with cisplatin and fluorouracil)
- locally advanced squamous cell carcinoma of the head and neck (in combination with cisplatin and fluorouracil)
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.
How Does Taxotere Work?
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.
Does Taxotere Cause Permanent Hair Loss?
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:
- 258 had been administered doxorubicin, but no taxane
- 126 had been administered doxorubicin and paclitaxel, Taxotere’s main competitor
- 112 had been administered doxorubicin and docetaxel, or Taxotere
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.
Did Sanofi Warn Patients?
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.
Is There An Alternative?
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.
Are There Generic Versions Available?
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.
What Other Side Effects Are There?
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:
- severe neutropenia – an abnormally low level of the white blood cells known as neutrophils
- severe leukopenia – an abnormally low level of the white blood cells known as leukocytes
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.
Like most chemotherapy drugs, Taxotere’s side effects are numerous. To learn more, click here.
Latest Taxotere News
By Michael Monheit
December 21, 2016- Settlement Committees Established For Taxotere Lawsuits
A Pretrial Order issued in the U.S. District Court, Eastern District of Louisiana, states that the members of plaintiffs’ and defendants’ settlement committees are going to engage in continuous general settlement discussion on a regular basis, instead of partaking in detailed discovery, trial preparations, and presentation at trial. These activities are believed to distract the parties from pursuing the correct avenues for potential resolution of some or all of the issues related to the Taxotere litigation. The federal court’s step of establishing these settlement committees is considered to be unusual.
November 30, 2016- Taxotere Lawsuits Moving Forward In A Multidistrict Litigation
Lawsuits that were filed on behalf of cancer patients who stated that they experienced permanent hair loss after receiving treatment using Taxotere have started to move forward in a multidistrict litigation. The multidistrict litigation was recently established in the U.S. District, Eastern District of Louisiana. The first Status Conference was convened on November 10th and was followed by the issuance of two new Orders. The first Order was dated on November 16th and stated that the applications for Special Counsel for Settlement Negotiations be emailed to chambers no later than December 5th, 2016. The second order dated November 17th established the litigation’s leadership structure.
September 27, 2016- Taxotere Under Consideration For Federal Court Proceedings
Sanofi’s breast cancer drug Taxotere is among a number of lawsuits that are under consideration as consolidated federal court proceedings. Product liability and consumer lawsuits account for over half the matters that are set aside for argument before the U.S. Judicial Panel on Multidistrict Litigation at the panel’s upcoming September 29th hearing. Sanofi supports the consolidation but has urged the panel to send the lawsuits to the District of Colorado. Colorado is where the first Taxotere lawsuit was filed, alternatively, they can be sent to the District of New Jersey where Sanofi-Aventis has its headquarters.
August 31, 2016- Louisiana Woman Files Taxotere Lawsuit For Hair Loss
A woman from Louisiana has filed a lawsuit, stating that her using of the breast cancer drug Taxotere caused her to have permanent alopecia, or a complete failure of her hair to regrow after undergoing treatment with the medication. In this case, the plaintiff was diagnosed with ductal carcinoma in early 2010 and started chemotherapy with Taxotere in September of the same year. She ended up getting four rounds of treatment with the drug, but she was never informed of the possible permanent disfiguring hair loss that might occur. It is being argued that the defendant did not dutifully disclose information about a connection between Taxotere and permanent hair loss.
June 30, 2016- Taxotere Lawsuit Filed In Mississippi As Hair Loss Litigation Grows
A new Taxotere lawsuit was recently filed in the U.S. District Court, Southern District of Mississippi. The lawsuit was filed by a woman who developed permanent alopecia after using the chemotherapy drug. The woman alleges that Sanofi-Aventis did not properly warn doctors and patients that Taxotere caused permanent hair loss at a much higher rate than other chemotherapy drugs on the market that are just as effective. The plaintiff was diagnosed with left breast cancer in 2013 and underwent chemotherapy that involved the use of Taxotere. She claims that had Sanofi-Aventis given the correct warming, many cancer patients would have made an informed decision about their treatment.
May 31, 2016- North Carolina Woman Files Taxotere Lawsuit
A woman from Raleigh, North Carolina filed a lawsuit against Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S. LLC on May 23, 2016. The woman is accusing the makers of the breast cancer drug Taxotere for not properly warning doctors and patients that the drug can cause permanent disfiguring hair loss, as well as for misrepresenting the safety of the drug and its effectiveness. Her claim also states that the drug makers should have known the rate of hair loss linked to Taxotere was greater in comparison to other products available to treat the same condition.
April 29, 2016- Woman Seeks $75,000 Compensation In Taxotere Lawsuit
A woman is suing Sanofi S.A. stating strict products liability in connection with their drug Taxotere. The woman’s lawsuit claims that both she and her treating doctors were not aware of neither were they informed of the possible danger of permanent alopecia that can happen due to Taxotere administration. Because of this, the plaintiff states that she suffered serious personal injuries that were debilitating. The woman filed her lawsuit in the United States District Court, Northern District of California, where she is seeking over $75,000 in compensation.