Information about the temporary distribution of Partusisten 5 mg tablets
Boehringer Ingelheim Zagreb d.o.o. , the marketing authorisation holder for Partusisten 5 mg tablets (fenoterol) has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) decided to temporary interrupt the distribution of the medicinal product as a precaution measure until the outcome of the arbitration procedure in the course in the EU for short-acting beta agonists in obstetric indications, due to findings that indicate an insufficient efficacy of oral forms of these medicines.
We remind that on 17 September 2013 HALMED reported about the recommendation of the Pharmacovigilance Risk assessment Committee (PRAC) of the European Medicines Agency (EMA) that oral and suppository forms of short-acting beta-agonists should no longer be used in obstetric indications. PRAC concluded that the data about the efficacy of oral and suppository forms of these medicinal products in the aforementioned indications are restricted and that modern medical knowledge do not substantiate their use. Therefore PRAC concluded that previously well-known heart and cardiac adverse reactions to these medicines are not acceptable any more, with regard to modest data of these medicines in obstetric indications. More about PRAC recommendations from September 2013 you may read here.
Bearing in mind that short-term beta agonists are authorised via national procedure in Member States, the PRAC recommendations are forwarded for adoption to the Co-ordination Group for Mutual recognition and Decentralised Procedure (CMDh). The CMD decision that is legally binding for the Republic of Croatia is expected in October 2013. If the CMDh adopts the PRAC recommendations, Partusisten 5 mg tablets (fenoterol) will no longer be placed on the market in Croatia.
The text of these information about the temporary interruption of distribution addressed to wholesalers is available here.
The monthly consumption of this medicine is low and HALMED in its spontaneous reporting system has not received any signal about higher risks of fenoterol use. HALMED will continue to monitor the safe use of short-acting beta-agonists and will promptly inform the public about about any new safety information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.