The National Medicines Safety Agency announced on Wednesday August 26 the withdrawal of this authorization, given the risks of encephalopathy.
Ifosfamide solution (Ifosfamide EG) will no longer be prescribed in France. This cancer treatment is used in the treatment of soft tissue sarcomas or lymphomas.
An increase in encephalopathies in 2015
Since 1993, cases of encephalopathy, damage to the central nervous system, in patients treated with Ifosfamide have been reported. “Symptoms may consist of a feeling of confusion (drowsiness, dumbness, but also disorientation, agitation, behavioral problems)”, specifies the ANSM. She adds that they are generally reversible either by decreasing the dosage or by stopping the treatment.. “As early as 2015, pharmacovigilance data showed an increase in cases of encephalopathy with the specialty Ifosfamide EG”, says the organization. This could be related to the “presence of impurities resulting from the spontaneous degradation of the product”. This increase in cases led the ANSM to reduce the shelf life of the drug, from 18 to 7 months.
A European reassessment in progress
Last October, the ANSM published the results of a pharmacovigilance study conducted by the regional pharmacovigilance centers of Montpellier and Clermont-Ferrand. “Despite the reduction in the shelf life, the increased risk of encephalopathy persists in children treated with Ifosfamide EG in the pediatric oncology department, compared to those treated with Holoxan”, they concluded. This led the ANSM to seize the European Medicines Agency for a reassessment of the treatment. It started in March 2020 and is still ongoing. The laboratory producing the drug stopped distributing it in France at the end of 2019. It recently announced its intention to deliver it again to pharmacies before the end of this evaluation. This change in policy led the ANSM to withdraw the marketing authorization for Ifosfamide EG “due to the potential increased risk to patients.”
Alternative medication is available
The drug is also available in powder form, marketed as Holoxan. “The specialty Holoxan should be used instead of Ifosfamide EGsays the organization. The ANSM has ensured that the stocks of Holoxan allow the care of patients requiring treatment with Ifosfamide.
Ifosfamide (chemotherapy): a study carried out by @Network_CRPV shows a greater risk of encephalopathy with the solution form (Ifosfamide EG)
We seize the European Medicines Agency @EMA_News to reassess this risk
➕info: https://t.co/3fdjrXyAyy pic.twitter.com/veuade8uN0
—ANSM (@ansm) October 2, 2019
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