Public Statement on Trovan / Trovan IV / Turvel / Turvel IV (Trovafloxacin/Alatrofloxacin) recommendation to suspend the marketing authorisation in the European Union

News 15/06/1999

The European Commission granted marketing authorisations for the whole European Union to Pfizer Limited on 3 July 1998 for TROVAN (trovafloxacin) and TROVAN IV (alatrofloxacin) and to Roerig Farmaceutici Italiana S.p.A. on 8 July 1998 for TURVEL (trovafloxacin) and on 3 July 1998 for TURVEL IV (alatrofloxacin).

The scientific Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA), during its extraordinary meeting on 10 June 1999, adopted an Opinion recommending the suspension of the marketing authorisation of TROVAN/TROVAN IV and TURVEL/TURVEL IV. This was due to increasing concerns over 152 documented reports of serious hepatic events, including 9 cases where patients died or required a liver transplant. The background to this procedure and the grounds for the suspension are provided in Annex 1. Following the CPMP meeting on 19 May 1999, as a precautionary measure, the CPMP had already alerted health care professionals to the occurrence of serious, severe and unpredictable liver injuries associated with trovafloxacin/alatrofloxacin administration. The CPMP had also decided to re-assess the risk/benefit profile of the medicinal products containing trovafloxacin/alatrofloxacin (see Public Statement on TROVAN/ TROVAN IV/ TURVEL/ TURVEL IV No EMEA/15770/99 dated 25 May 1999).

TROVAN1/ TROVAN IV2 is currently marketed in eight member states of the European Union (Austria, Denmark, Finland, Germany, Netherlands, Portugal, Spain and Sweden). TURVEL3 is currently marketed in the European Union in only one Member State, Spain. The above mentioned Opinions have been forwarded to the marketing authorisation holders, the Member States, and the European Commission. The European Commission has initiated the decision making procedure relating to the suspension of the marketing authorisations. The Commission has notified the competent authorities of the Member States that the process has started and recommended that they suspend the use of TROVAN/ TURVEL and TROVAN IV/ TURVEL IV. Existing supplies of TROVAN/ TURVEL and TROVAN IV/ TURVEL IV will consequently be withdrawn from pharmacies and wholesalers.

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