Lawsuits Mount Over Cancer Drug’s FDA Black Box Warning

FDA black box

The manufacturer of a chemotherapy drug called Taxotere is the subject of snowballing litigation after claims that the drug causes permanent alopecia, or hair loss.  Though hair loss is a common side effect of cancer treatments, the cancer survivors bringing suit claim the risk of permanency of their hair loss was not disclosed and should have had an FDA black box warning.

Taxotere is a chemotherapy drug that is a popular choice of cancer treatment in the United States.  It is most often used as treatment for:

  • Breast cancer
  • Non-small cell lung cancer
  • Hormone refractory prostate cancer
  • Gastric adenocarcinoma
  • Squamous cell carcinoma of the head and neck

Taxotere is most frequently used for breast cancer, which makes it the most prescribed drug in its class.  Surviving cancer patients report permanent hair loss, or alopecia, as a side effect of the drug.

Unlike most cancer treatments which cause hair loss during the treatment period, Taxotere has caused patients to lose their hair permanently.  Victims say their permanent hair loss causes:

  • Severely decreased quality of life
  • Affected body image
  • Depression and distress
  • Is often accompanied by other disfiguring symptoms like skin reactions, neurologic reactions, and eye disorders

The manufacturer sponsored a trial in the late 1990’s and found that 9.2 percent of women who used Taxotere suffered permanent alopecia.  Despite this finding, no warnings were provided to consumers.

FDA Black Box Warnings about Taxotere

Since being approved for use in the United States in 1996, the drug Taxotere (docetaxel) has been the subject of multiple FDA black box warnings.  The most recent is the 2015 black box warning about the risk of permanent alopecia.

In 2015, the U.S.  Food and Drug Administration (FDA) required Sanofi-Aventis to update labels on all products containing the drug docetaxel.  The updated label included a black box warning that Taxotere included a risk for permanent hair loss, or alopecia.  Before that time, however, numerous victims had suffered the side effects without adequate warning.

Other FDA black box warnings that may cause serious injury or death related to Taxotere include:

  • Increased risk of death for patients with liver damage or abnormal liver function
  • Severe fluid retention
  • Risk of hypersensitivity to irritants which can escalate to anaphylaxis (severe allergic reaction).  Anaphylaxis can be fatal if the patient doesn’t receive emergency treatment right away.

Flood of Lawsuits for Alopecia and Other Disfiguring Side Effects

Until December 2015, Taxotere did not have an FDA black box warning label about the risk of permanent hair loss.  Worse, breast cancer survivors and other plaintiffs allege:

  • The words “permanent hair loss” or “alopecia” do not appear on any marketing material distributed in the U.S.
  • The manufacturer hid research related to the side effects of the drug.
  • The manufacturer promoted the drug knowing the possibility of alopecia when another lower-potency drug called Taxol may not have carried the same hair loss risks.

Plaintiffs allege that the manufacturer was aware of the dangers and side effects of Taxotere results since at least 2005 and yet continued to mislead the public with marketing that assured patients that their hair would grow back following cancer treatment.

So many cancer survivors have suffered disfigurement, and subsequently filed lawsuits, that the courts centralized the litigation into one district, the Eastern District of Louisiana.  This multidistrict litigation (MDL) involves hundreds of individual lawsuits and will likely involve dozens more.

If you are a cancer survivor and have been diagnosed with alopecia after taking Taxotere, contact Drug and Device Watch to find out if you qualify to enter the related MDL.  Click here to find out more.

FDA Black Box Warnings

An FDA black box warning, sometimes also called a boxed warning, appears on a pharmaceutical drug label.  It is the FDA’s most critical warning for consumers about prescription drugs.  The term “black box” refers to the literal black box the FDA puts around their warning on the drug’s label.  The goal of the black box is to call attention to important warnings the FDA deems serious enough to set apart from the other drug information on the label.

Hair Loss and Chemotherapy

Temporary hair loss normally occurs during chemotherapy because the medications that attack cancer cells also attack other rapidly growing cells in the body.  That’s why chemotherapy can cause hair loss all over your body, not just on the scalp.

The hair loss that patients should expect varies widely with each cancer medication.  Patients should be able to rely on their doctors and pharmacists to describe the hair loss risk of any drug they will receive during treatment.  Cancer survivors with permanent alopecia from Taxotere are filing lawsuits because the drug manufacturer did not publish any warnings about the possibility of permanent hair loss.

Most hair loss related to chemotherapy is indeed temporary, with hair growing back within 3-6 months after completing treatment.  Hair loss may seem like a small price to pay for a treatment that allows patients to fight cancer, but victims report significant distress from permanent hair loss.

Every time they look in the mirror, they see a reminder of their illness and all the experiences and pain that accompanied it.

Hair loss from chemotherapy cannot be completely prevented, but there are some treatments to help cancer patients minimize the hair lost:

  • Scalp Cooling Caps – A closely fitted cap filled with chilled liquid designed to slow blood flow to the scalp and reduce the cancer drugs’ effect on a patient’s hair.  Though the caps do help minimize hair loss somewhat, they also carry a slight risk of cancer reoccurrence in the scalp since the area will receive a smaller dosage of treatment than the rest of the body.
  • Minoxidil (Rogaine) – Applying this drug is approved for hair loss.  It usually doesn’t prevent loss for cancer patients, but it does seem to help patients re-grow hair more quickly after concluding treatment.

Sadly, neither of these treatments would be of any use to victims of permanent alopecia caused by Taxotere.

What to Do if You Have Permanent Hair Loss from Chemotherapy

If you have received chemotherapy, and suffered from permanent alopecia prior to the application of the FDA black box label, you should speak to an attorney about your experience.  An FDA black box warning attorney will review information about your:

  • Cancer diagnosis
  • Course of treatment
  • Duration of usage of a drug such as Taxotere
  • Complications experienced
  • Treatment or follow-up

If your diagnosis of alopecia is related to Taxotere use, you may qualify to enter the ongoing MDL.  Contact Drug and Device Watch to learn more about your options, and the possibility that you are entitled to compensation for your injuries.

To schedule a free consultation, call us at 1-888-458-6825, or contact us online.