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8A.4 SAEs, drug overdoses, psychoses and seizures following the discontinuation of co-prescribed heroin treatment

As described earlier in chapter 5A, a total of 55 patients completed the 12 months treatment with co-prescribed injectable heroin. During the two months following the discontinuation of this treatment, one SAE was documented. The SAE was classified as a hospital admission, not related to the (discontinuation of the) heroin medication. The hospitalization occurred for a complicated cruris fracture (an open wound, involving wound infection and requiring skin transplant).

Among the 55 treatment completers in group B, no drug overdoses, psychoses or seizures were documented during the two months following the discontinuation of the co-prescribed heroin treatment.

  • The incidence of serious adverse events during the twelve months treatment period was comparable between the co-prescribed heroin treatment group and the methadone alone group.

  • The observed total of 11 serious adverse events in the co-prescribed heroin group, of which four events were considered to be possibly related to the study medication, occurred in the context of approximately 45,000 heroin dispensations.

  • No serious adverse events were observed that were related to the discontinuation of the co-prescribed heroin treatment at the end of the experimental treatment period.