All manufacturers of antitumor drugs with API ifosfamide need to add new data on the safety of the use of such drugs to the instructions for use, Katren Style reports. The corresponding instruction of the Ministry of Health of the Russian Federation is published in the State Register of Medicines (GRLS).
As stated in the document, it is necessary to include the information about the drug’s neurotoxicity in the Special Warnings section of the instructions. According to the letter, symptoms of neurotoxicity during treatment with ifosfamide included confusion, drowsiness, coma, hallucinations, and a number of other phenomena.
It is also noted that the neurotoxicity of ifosfamide in most cases ends after some time after discontinuation of the drug administration. In some cases, the recovery was incomplete.
According to the GRLS, four trade names of drugs with ifosfamide as an API are registered in Russia.
The Ministry of Health of the Russian Federation also demanded that the instructions of eight antidepressants be changed.
