Updated: EMA Warns of Possible Chemotherapy Shortage in Four Countries Due to Sanofi Manufacturing Snafu

Regulatory NewsRegulatory News
| 10 June 2016 | By Zachary Brennan 

Fifteen batches of Sanofi’s chemotherapy Taxotere (docetaxel) have been recalled due to a problem in the manufacturing process that could have led to vials being too concentrated, the European Medicines Agency (EMA) said in an updated alert on the possible shortage on Thursday.

A failure in the filling process at Sanofi’s manufacturing site in Germany has led to Taxotere vials being up to 5% over-concentrated, EMA said. The drug is used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer.

“Some of the vials released to the market may have already been used,” the regulator said, noting a “small risk that patients who have received the affected vials may have received more docetaxel than was intended.”

As a consequence of the recall, Taxotere 20mg/1 ml and 80 mg/4ml concentrate for solution for infusion may become unavailable in France, Ireland, Italy and Spain, though normal supply is expected to resume on 19 August 2016, EMA added.

According to the UK’s Medicines and Healthcare products Regulatory Agency, which first announced the recall in April, a software failure during filling of this batch potentially resulted in the evaporation of Ethanol from a small number of vials and a consequent increase in the concentration of docetaxel in the solution.

The batches impacted are for Taxotere (docetaxel) concentrate for solution for infusion vial (20mg / 1 ml and 80mg / 4 ml).

“Healthcare providers should carefully monitor all patients who have received the affected vials for signs of toxicity and treat these as appropriate,” EMA said. “Any suspected adverse reactions should be reported to the national competent authority… As a consequence of the recall, Taxotere 20 mg/1ml and 80 mg/4ml concentrate for solution for infusion may become unavailable in some EU member states and patients may have to be switched to an alternative docetaxel-containing medicine.”

Sanofi said that in 2015, Taxotere sales worldwide amounted to €222 million ($251 million), with the bulk of sales coming outside of western Europe. Sales of the drug also fell more than 22% compare to the previous year because of new docetaxel generics entering the market. Sanofi did not respond to a request for comment.

Sarah Connors, head of global immunology and oncology communications at Sanofi, told us: "The absolute amount of drug substance per unit is not impacted even for the concerned units. The root cause has been identified and corrective actions have been implemented to correct the failure. No shortage has been identified at patient level in Europe." 

EMA Notice

Editor's note: Story updated on 6/10/16 with comment from Sanofi.


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