Inspiron withdrawn from circulation
On 23rd May 2019, Ukraine’s State Inspectorate for Quality Control of Medicines ordered to permanently withdraw from circulation in the country all fenspiride-containing medicinal products and cease production, sale, storage, and use thereof. Arterium Corporation’s Inspiron tablets and syrups have been affected too. The move is inspired by the recommendation of the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) aimed at preventing the realization of risks in cardiovascular patients. Over the past three months, PRAC thoroughly reviewed the lab data provided by Servier, the producer of the original drug having fenspiride as an active pharmaceutical ingredient (API). “Fenspiride molecule has been used in medical practice for over 40 years, and no clinical cases of its side effects with an adverse outcome have been identified thus far. The withdrawal is to prevent the development of possible risks going forward,” Arterium Corporation’s Pharmacovigilance Manager Rimma Battalova commented. “So, there is nothing to worry about for those who used fenspiride-based drugs before – fenspiride molecule is quickly metabolized and does not build up in bodily systems.”