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Taxotere

Truth: Studies show that up to one in ten Taxotere patients suffer alopecia, or permanent disfiguring hair loss all over their body.

Truth: In 2005, Taxotere manufacturer Sanofi-Aventis warned European Union doctors and patients about the risk of alopecia in patients – but didn’t warn U.S. doctors and consumers until 2015.

Truth: As of November 2018, there are more than 10,000 women who have filed legal action against Sanofi-Aventis for the suffering they’ve endured from their Taxotere breast cancer treatment.

Despite Sanofi-Aventis warning the European Union and Canada of Taxotere’s devastating risks, the company failed to warn U.S. consumers until a decade later.

Additionally, the FDA has sent two warnings to the manufacturer for using misleading marketing to convince consumers that Taxotere was more effective than other cancer treatments – even though there’s no clear evidence to support the claims. On the contrary, some research suggests that Taxotere may be more harmful than other competitor treatments like Taxol.

It’s clear as day that Sanofi-Aventis has been putting profits over people for more than a decade. If you’ve suffered from the company’s negligence and disregard, we can help you fight back. Contact us now.

What Is Taxotere?

Taxotere is an injectable chemotherapy drug manufactured by Sanofi-Aventis. It received U.S. Food and Drug Administration (FDA) approval in June 1996 to treat breast cancer.

Since its debut on the market, it has been used to treat other various types of cancer, including cancers of the stomach, prostate, head and neck, and a type of lung cancer called non-small cell lung cancer.

Taxotere is often prescribed for patients with advanced or metastatic cancer or aggressive cancers that spread to other areas of the body. Many Taxotere patients have failed to see results from prior chemotherapy treatments.

While temporary hair loss is a common side effect of chemotherapy, it typically re-grows after three-to-six months. Taxotere is under fire from thousands of patients whose hair hasn’t grown back years after their treatment ended.

How Does Taxotere Work?

The drug’s generic name is docetaxel, which belongs to a family of drugs called taxanes. Taxotere and other taxanes work by destroying cells that divide rapidly. Specifically, taxanes disrupt the function of microtubules, which are microscopic components of cells that play a key role in mitosis, or cell division and multiplication.

While this is helpful for stopping cancer cells from spreading, it can be harmful to the body’s other fast-growing cells like hair follicles.

Because Taxotere is something of a “last resort” treatment, it’s typically administered in a higher potency than other cancer medications. This higher potency means that patients can receive treatment less often than with other cancer medications – every three weeks compared to every week. However, this may mean that the side effects can be more severe.

The medication is administered through an intravenous (IV) infusion that lasts one hour. In many cases, it’s administered with other medications.

Taxotere Use Warnings

Taxotere shouldn’t be used in the following situations:

  • While pregnant, as the drug may cause harm to a developing fetus
  • While nursing, as it’s unknown if the drug is passed through breast milk
  • In conjunction with any “live” vaccines

Additionally, patients with existing liver problems should be carefully pre-screened and monitored during treatment, as they may experience more severe side effects and are at a higher risk of death during treatment.

Effectiveness and Safety Compared to Other Treatments

Several studies suggest that, despite Sanofi-Aventis’s claims, Taxotere (docetaxel) isn’t superior to its competitors like Taxol (paclitaxel).

In fact, one study published in the journal ClinicoEconomics and Outcomes Research showed that docetaxel had significantly higher side effects in patients. It also concluded that, overall, it didn’t provide a significant benefit over paclitaxel.

What Are the Risks of Taxotere?

FDA Black Box Warning

Black Box Warning

In 2006, the FDA issued what’s commonly known as a “black box warning” or “boxed warning,” which is the most severe warning the FDA requires manufacturers to include on their drug labels. It warns about life-threatening side effects including:

  • Increased risk of death in patients with liver problems
  • Neutropenia, or decreased count in white blood cells
  • Severe edema, or fluid retention that can cause deadly complications
  • Severe hypersensitivity or anaphylaxis, a life-threatening allergic reaction

Other Side Effects

Other Taxotere side effects include:

  • Nausea and vomiting
  • Increased risk of infections
  • Weakness and fatigue
  • Diarrhea
  • Difficulty breathing
  • Hair loss
  • Constipation
  • Irregular menstrual periods
  • Easy bleeding and bruising
  • Increased blood pressure
  • Fever and chills
  • Bloody stools or urine
  • Joint and muscle pain
  • Weight gain
  • Mouth sores
  • Appetite loss
  • Anemia (low red blood cells)
  • Skin rash or hives
  • Numbness and tingling in hands and feet
  • Changes or discoloration in fingernails and toenails
  • Allergic reactions at the injection site

Alopecia & Permanent Hair Loss

Several studies have shown that cancer treatment with docetaxel and other taxanes has been linked to alopecia, a condition that causes permanent hair loss all over the body. In fact, these studies suggest that it’s as common as one in every ten patients.

In alopecia, the patient’s immune system attacks the hair follicles. As a result, the body fails to grow hair anywhere, including the scalp, eyebrows and eyelashes, genitals, underarms, and other areas.

One study published in the journal Annals of Oncology followed 20 women who experienced alopecia after their treatment with docetaxel and another drug. The results ruled out several other potential causes of hair loss, including iron or zinc deficiency, thyroid disorders, and hormonal menopause issues.

It also showed that treatment including vitamins, ultraviolet A therapy, and three other substances used to treat hair and skin issues (minoxidil, psoralen, and spironolactone) were ineffective in regenerating hair growth.

Emotional Distress and Suffering

It’s not surprising to hear that many individuals view their hair as a central component of their identity.

For this reason, many alopecia sufferers have reported psychological issues like:

  • Shame and embarrassment
  • Lower self-esteem and poorer body image
  • Depression and anxiety
  • Difficulty returning to work or everyday life

This is heightened in female patients, who often also report feeling a loss in their sense of femininity and attractiveness.

Additionally, patients report feelings of helplessness and revictimization. It’s not simply hair loss – it’s a constant and painful reminder of the intense physical and psychological price that they paid to be free of cancer.

The Annals of Oncology study also showed significant psychological consequences for the 20 women observed. Nearly two-thirds of women were too embarrassed to be seen as bald, wearing a wig or scarf to cover their scalp.

Women who are taking legal action against Sanofi-Aventis claim that if they were adequately warned of the risk, they would have chosen another treatment with similar efficacy. One woman even said she would have rather lost her breasts than her hair.

Taxotere’s Global Regulatory History

Taxotere’s Global Regulatory History

The regulatory history of Taxotere has acted as strong evidence that, for more than a decade, Sanofi-Aventis has been continuously misleading and neglecting the wellbeing of its patients.

Here’s a timeline that highlights some key regulatory issues:

May 1996: Taxotere is approved by the FDA for breast cancer treatment in the United States.

December 2002: The FDA sent a warning letter to Sanofi-Aventis for marketing materials that violated the Federal Food, Drug, and Cosmetic Act by making misleading effectiveness claims and omitting critical usage and safety information.

One of these misleading claims read: “Because Taxotere is generally safe and tolerable, you can stay involved in important aspects of your life.” Anyone who knows the devastating impact of chemotherapy can tell you that this is simply not always true.

November 2005: Sanofi-Aventis updated the Taxotere label with the European Medicines Agency (EMA), which can be seen as the European Union’s version of the FDA. This updated label notified doctors and patients about the risk of permanent alopecia.

April 2009: The FDA sent another warning letter to Sanofi-Aventis for “Unsubstantiated Superiority Claims / Overstatement of Efficacy,” or essentially another instance of misleading marketing. The manufacturer claimed that Taxotere (docetaxel) was more effective than paclitaxel, despite inadequate evidence to make this claim.

May 2012: Sanofi-Aventis updated the Taxotere label with Health Canada, the Canadian regulatory agency similar to the FDA. Like the 2005 update with the EMA, Canadian doctors and patients were notified of the risk of permanent alopecia.

June 2014: The FDA issued a Safety Announcement warning that patients may become intoxicated from the alcohol Taxotere contains. For this reason, doctors should be aware of any adverse reactions with other medications, or in patients whose condition requires minimal or no alcohol consumption.

November 2015: Sanofi-Aventis updated the Taxotere label with the FDA, finally acknowledging the medication’s risk for “permanent or irreversible alopecia.”

Taxotere Lawsuits

As of November 2018, more than 10,000 people have filed a lawsuit against Sanofi-Aventis for Taxotere.

These lawsuits have been consolidated into a multi-district litigation case (MDL 2740) in a Louisiana district court. The purpose of an MDL is to group similar cases together, to help speed up the legal process and ensure that patients get justice in a timelier manner.

Similarly, more than 350 lawsuits were consolidated into a multi-county litigation (MCL) case in a New Jersey county court in October 2018.

The first bellwether trial for MDL 2740 is set to begin in early 2019, with four more bellwether trials set through 2020. Bellwether trials act as “example” cases – they set the stage for how future trials might be heard, including:

  • The types of compensation patients receive
  • The types of settlements that manufacturers are willing to pay
  • To what extent the plaintiffs’ claims are supported by the evidence they’ve submitted

Should I File a Taxotere Lawsuit?

If you’ve experienced the following after having cancer treatment with Taxotere, you may have a case:

  • Your body hair has failed to grow back after more than six months from ending treatment.
  • You’ve experienced severe psychological suffering from this hair loss.
  • You feel that your doctors and other medical professionals didn’t adequately warn you of the risks of permanent disfiguring alopecia.

We understand that a person’s hair is a core component of their identity. Women across the globe who weren’t warned about the risks have suffered unimaginable anguish and an unnecessary loss in their quality of life after being treated with Taxotere.

Taxotere victims may be able to receive financial compensation for:

  • Psychological pain and suffering
  • Medical costs as a result of the disfigurement
  • Missed work as a result of the disfigurement
  • Reimbursement for other costs, like hair regrowth therapies

If you believe you have a case, contact Farah & Farah as soon as possible. We believe that Sanofi-Aventis has been willfully disregarding the safety and wellbeing of vulnerable people and that they should pay the price for their malice.

Co-counsel will be associated on these cases.