Taxotere Recall Issued in U.K. Due to Concentration Errors for Breast Cancer Drug

Some doses of the cancer drug Taxotere are being recalled in Europe, due to a risk that they may contain over-concentrated amounts of the active ingredient, docetaxel. 

The Taxotere recall was announced by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) on April 20, impacting one batch of concentrate for solution for infusion.

The problems with Taxotere were caused by a production fault that resulted in an increase in the concentration of docetaxel in some doses.

Sanofi issued the recall after it found that a software failure may have caused the evaporation of Ethanol from some vials, leading to concentrated amounts of docetaxel. However, the total amount in the vials was unchanged. There are no indications of illnesses or injuries resulting from the software failure.

The recall affects Taxotere (Docetaxel) Concentrate for Solution for Infusion, 80mg per 4 ml, with a batch number of 5f219A and an expiry date of 31 August 2018. The incidence rate is anticipated to be about 0.09% of the batch.

Taxotere Side Effects

Taxotere is a cancer drug approved by the FDA in May 1996, which is given by injection with other chemotherapy drugs. It is used for treatment of patients with locally advanced or metastatic breast cancer after prior chemotherapy attempts had failed, competing with several other treatment alternatives.

It is part of a class of chemotherapy drugs known as Taxanes, but Taxotere was developed to be higher potency. However, recent concerns have emerged about whether that causes the drug to be more toxic, and side effects of Taxotere have been linked to reports of permanent alopecia, or hair loss that continues for years following chemotherapy.

Over the past year, a growing number of Taxotere hair loss lawsuits have been filed by women left with permanent alopecia after receiving the medication as part of chemotherapy treatment for breast cancer.

While chemotherapy often results in hair loss, it is usually temporary, and Plaintiffs point to claims made by the drug maker that hair generally grows back following Taxotere. However, that does not appear to be the case for many women.

Since other breast cancer treatment alternatives are available, which plaintiffs claim are at least as effective, the lawsuits allege that women were deprived of the opportunity to make an informed decision about whether to expose themselves to the long-lasting impact of permanent alopecia from Taxotere.