AIFA: withdrawn lots of Bayer’s drug Kogenate for the treatment of hemophilia A

After the alert issued by the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios – AEMPS), the office that ensures the quality, safety and efficacy of medicines and medical devices throughout their life cycle, as well as the correct information to operators and citizens, the Bayer Company by its own note dated August 5, 2016, announced that it has initiated the procedure for the precautionary recall of the medicinal specialty KOGENATE in the following packages: KOGENATE BAYER*FL1000UI+SIR+1K – AIC 034955068 – lot nn: ITA2JF5 expired. 3/2018 ITA2JV6 expired. 3/2018 ITA2L0H expired. 3/2018 KOGENATE BAYER*EV3000UI+SIR+DI – AIC 034955120 – lots nn.: ITA280U scad. 8/2016 ITA2K8V expires.

5/2018 ITA2KDR scad. 5/2018 ITA2L0N scad. 5/2018. The lots involved, points out Giovanni D’Agata, president of the “Sportello dei Diritti,” showed a faster-than-expected decrease in product titer during the latter part of the validity period.

Therefore, the Bayer Company is conducting a recall of the above lots. Any stocks of the lots involved should therefore be blocked and rendered. KOGENATE is used in the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency). This preparation does not contain von Willebrand factor and therefore is not indicated in von Willebrand disease.

This medicine is indicated for adults, adolescents and children of all ages.