Posted by: dhendricks, in: Dangerous Drugs ,

Overview of Taxotere – Taxotere (generic name: Docetaxel) is an intravenous injection used to treat mostly breast cancer patients but can also be used for neck, head or prostrate cancers. It should be noted that women who are planning on becoming pregnant should not use Taxotere as it may harm the fetus.

Taxotere is administered usually in a clinic or hospital over the course of an hour and usually for a 3 week term.

Sanofi-Aventis the maker of Taxotere gained FDA approval of its cancer fighting drug back in 1996.

It wasn’t until December of 2015 that the FDA forced the company to change its package label warning women of possible permanent hair loss known by its medical name alopecia (baldness).

However before the edits made to the Taxotere label it read: “hair generally grows back”. Failure to warn women of the possibility of permanent hair loss is the basis of this Taxotere lawsuit.

What are the most common adverse reactions and side effects associated with Taxotere?

According to the drug’s label, the most common adverse reactions are:

  • Infections
  • Neutropenia (low white blood cell count)
  • Anemia (low red blood cell count)
  • Febrile neutropenia (development of fever with low white blood cell count)
  • Hypersensitivity
  • Thrombocytopenia (low platelet count)
  • Neuropathy (weakness, numbness and pain from nerve damage, usually in the hands and feet)
  • Dysgeusia (persistent foul, salty or metallic taste sensation)
  • Dyspnea (difficult or labored breathing)
  • Constipation
  • Anorexia
  • Nail disorders
  • Fluid retention (edema)
  • Asthenia (abnormal physical weakness or lack of energy)
  • Pain
  • Nausea
  • Diarrhea
  • Vomiting
  • Mucositis (painful inflammation and ulceration of the mucous membranes in the lining of the digestive tract)
  • Alopecia (permanent hair loss)
  • Skin reactions
  • Myalgia (pain in a muscle or group of muscles)

Other possible side effects of Taxotere include:

  • Swelling of hands, feet or face
  • Decreased appetite
  • Mouth or lip sores
  • Watery eyes, redness of the eye
  • Muscle, bone, joint pain
  • Increases in blood tests measuring liver function
  • Allergic reactions like rash, flushing/hot flashes, fever, lowered blood pressure
  • Infusion site reactions like darkening of the vein, inflammation, redness or drying of the skin, swelling of the vein

What is alopecia and how is it associated with Taxotere?

Alopecia is a possible side effect reported by a number of women who were treated with Taxotere for breast cancer. Alopecia is a type of hair loss that occurs when the immune system attacks hair follicles, resulting in hair loss. Alopecia is usually not permanent; about 10 percent of people with the condition may never re-grow hair.Hair loss lawsuit

Hair loss is often associated with chemotherapy. However, the hair usually grows back once treatment has stopped.

Women who suffer from permanent alopecia after treatment with Taxotere may never re-grow their hair. Some women report the loss of their eyebrows and eyelashes, too. The makers of Taxotere estimate alopecia occurs in about three percent of patients, but some studies suggest that number is higher.

A study conducted by the Rocky Mountain Cancer Center in Colorado suggested about 6.3 percent of patients experienced alopecia when Taxotere was used in combination with other cancer-fighting drugs.

A survey conducted by the Clatterbridge Cancer Centre in the UK found 15.8 percent of respondents reported experiencing alopecia after using the generic version of Taxotere, docetaxel.

In December 2015, the FDA issued a warning about the possible risk of alopecia when undergoing treatment with Taxotere and its generic docetaxel. The FDA issued the warning in response to numerous adverse event reports submitted to the agency by patients and doctors.

Will my hair grow back after I stop treatment with Taxotere?

The majority of women will re-grow their hair after chemotherapy with Taxotere. On average, women who undergo chemotherapy with any drug will experience hair re-growth within a few weeks to a few months after ending treatment.

There is a percentage of women who may never re-grow their hair after treatment with Taxotere.

The makers of the drug estimate permanent hair loss occurs in about three percent of patients. Some studies estimate this percentage is much greater and could be anywhere from six percent to almost 16 percent.

Has the FDA issued any warnings about Taxotere?

The FDA has issued several warnings regarding Taxotere since the drug was approved 20 years ago.

Taxotere carries a “black box” warning, the FDA’s strongest warning about a drug or medical device. Black box warnings indicate there is a serious risk of hazard or even death associated with the product.

Taxotere’s black box holds several warnings for consumers and doctors including the risk of:

  • toxic death in patients with abnormal liver function
  • hepatoxicity in patients with high bilirubin concentrations
  • low white blood cell counts
  • hypersensitivity reactions and fluid retention

The FDA has also issued numerous safety communications in the past several years regarding Taxotere. Some of those warnings include the risk of:

  • renal (kidney) failure
  • respiratory problems, including failure
  • metabolism and nutrition disorders
  • eye disorders
  • permanent alopecia

What other chemotherapy drugs are used to treat breast cancer?

Taxotere is not the only chemotherapy drug on the market used to treat breast cancer.

The following are also used to treat early and locally advanced breast cancer (brand names are listed in parentheses):

  • Cyclophosamide (Cytoxan)
  • Doxorubicin (Adriamycin)
  • Epirubicin (Ellence)
  • Methotrexate (Maxtrex)
  • Paclitaxel (Taxol)

The following are also used to treat metastatic breast cancer (brand names are listed in parentheses):

  • Capecitabine (Xeloda)
  • Carboplatin (Paraplatin)
  • Cisplatin (Platinol)
  • Cyclophosamide (Cytoxan)
  • Doxorubicin (Adriamycin)
  • Epirubicin (Ellence)
  • Eribulin (Halaven)
  • 5-Fluorouracil (Adrucil)
  • Gemcitabine (Gemzar)
  • Ixabepilone (Ixempra)
  • Liposomal doxorubicin (Doxil)
  • Methotrexate (Maxtrex)
  • Paclitaxel (Taxol)
  • Paclitaxel, albumin bound (Abraxane)
  • Vinorelbine (Navelbine)

Both Taxol (paclitaxel) and Taxotere are in the same taxane drug class. Both are derived from the yew tree.

How often is Taxotere prescribed?

About 1 in 8 women (about 12 percent) will develop invasive breast cancer in her lifetime. In 2016, it is estimated over 246,000 new cases of invasive breast cancer will be diagnosed, including an additional 61,000 new cases of non-invasive breast cancer, according to the American Cancer Society.

Taxotere is the most widely prescribed drug in its class to treat breast cancer. Up to 75 percent of breast cancer patients in the United States use Taxotere during their treatment.

If you or someone you love has suffered from permanent hair loss from using Taxotere, we can help ease the burden. Read about the Taxotere lawsuits here.

Posted by: dhendricks, in: Dangerous Drugs ,