The Medicines Agency (ANSM) announced this Wednesday, August 26, the suspension of the marketing of an anticancer drug, Ifosfamide EG, due to an increased risk of encephalopathy, brain disease.
The drug concerned is ifosfamide “in solution”, that is to say in the form of a liquid ready to use to be administered by infusion, marketed by the laboratory EG Labo under the name Ifosfamide EG. This chemotherapy molecule also exists in powder form, under the trade name of Holoxan, which presents less risks and “should be used in place of Ifosfamide EG”, indicates the ANSM.
Ifosfamide is indicated for the treatment of several cancers in adults and children, including soft tissue sarcomas and lymphomas. “As early as 2015, pharmacovigilance data showed increased cases of encephalopathy“with Ifosfamide EG, which” could be explained by the presence of impurities resulting from the spontaneous degradation of the product “, explains the health agency on its website.
A potential increased risk for patients
The ANSM then decided to reduce the shelf life of Ifosfamide EG from 18 months to 7 months. But in October 2019, a study showed that despite the decrease in shelf life, this “excess risk” persisted in children treated with this medicine.
The ANSM asked a reassessment of Ifosfamide EG by the European Medicines Agency, which started in December, and the EG Labo laboratory (a subsidiary of the German pharmaceutical group Stada) had stopped its distribution in France a little after.
But “the latter having expressed his intention to distribute his drug again”, without waiting for the end of the European re-evaluation process, “we take the decision to suspend the marketing authorization because of the potential additional risk for patients, ”explains the ANSM in its press release.
The health agency adds that it has “made sure that stocks of Holoxan,” produced by the American laboratory Baxter, “allow patient care requiring treatment with ifosfamide “.
