Indian-Made Docetaxel—a Generic Form of Taxotere®—Linked to Five Fatalities in France

vials of medicineDocetaxel, more commonly known by the brand name Taxotere, is a popular chemotherapy medication used primarily to treat breast cancer. Although Taxotere is one of the most-prescribed drugs in its class, patients report a number of serious side effects, including permanent hair loss.

Now, a generic version of the drug has been linked to five fatal cases of neutropenic enterocolitis in France, sparking an investigation by the French National Drug and Health Product Safety Agency (ANSM) and causing one prestigious oncology center to stop using docetaxel entirely. 

What Is Neutropenic Enterocolitis?

Neutropenic enterocolitis is a life-threatening condition characterized by the inflammation of the mucus membranes lining the small intestine and colon, which can cause nausea, abdominal pain or tenderness, vomiting, diarrhea, fever, chills and a distended abdomen. And, as was the case with the five French patients being treated with docetaxel, neutropenic enterocolitis can also be sadly fatal. Although neutropenic enterocolitis is considered rare, it occurs most frequently in patients who've received intensive chemotherapy treatments.

To limit the risk of developing neutropenic infection, France's health safety agencies recommend that doctors conduct frequent and thorough blood count monitoring of all patients undergoing docetaxel treatment.

The five fatalities were female breast cancer patients between the ages of 46 and 73. Their deaths reportedly occurred between August 2016 and February 2017.

What Company Manufactured This Generic?

The generic docetaxel linked to the five fatal neutropenic enterocolitis cases wasn't manufactured or marketed by Sanofi-Aventis, the makers of Taxotere. Instead, this generic docetaxel was manufactured and marketed by Indian pharmaceutical companies Accord Healthcare and Intas Pharmaceuticals. Although some may be tempted to blame the deaths on a generic that just wasn't up to snuff, the docetaxel lots in question were checked and verified for quality.

ANSM Investigation

In August, after the first three deaths were announced, the ANSM and the French National Cancer Institute (INCa) launched an exhaustive pharmacovigilance investigation into all therapies that use docetaxel. Because nothing appeared wrong with the Indian-made generic docetaxel, the ANSM and INCa stopped short of recommending that sales of the drug be suspended, or that the drug be removed from the market.

However, in its release, the organization did mention that concerned patients may find paclitaxel to be a suitable alternative to docetaxel. The results of the investigation are expected to be released at the end of March 2017.

Fallout Over Docetaxel

Though the ANSM and INCa have so far been unable to point to any flaw with the docetaxel itself, at least one French oncology clinic has announced that they will stop using docetaxel to treat their patients. The prestigious Institut Curie in Paris has had two patients die from neutropenic enterocolitis after being treated with docetaxel. As a result, Institut Curie has switched to the ANSM-suggested alternative, paclitaxel. 

“As a precaution, given the occurrence within an unusually short period of time, of these two similar cases at the Institut Curie and those at other healthcare facilities in France, the Institut Curie has stopped using docetaxel to treat breast cancer. It has been replaced with paclitaxel,” the Institut said in a press release. Only time will tell if other French hospitals and oncology clinics decide to follow suit and stop using docetaxel entirely.

Are You Considering a Taxotere Lawsuit?

Battling cancer is hard enough without having to worry about the slew of related side effects and complications related to its treatments. If you've suffered serious Taxotere side effects, such as permanent hair loss, it can seem like even if you beat the cancer, life will never be the same. Looking in the mirror and not recognizing the person staring back can be devastating.

Here at McGartland Law, our team of knowledgeable attorneys has 30 years of experience handling injury cases nationwide. If you're considering a Taxotere lawsuit, we can help. Contact us today to schedule an appointment for a free initial consultation. Our attorneys are eager to help you fight for whatever compensation you deserve.

 

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