The State Unitary Enterprise "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment" received information on the results of studies on the pharmacological safety of the drug fenspiride in in vitro experiments, dedicated to assessing the balance of benefits and risks for the state of the channels of the hERG cardiac conduction system.

In particular, in experiments on isolated and perfused hearts of guinea pigs by measuring ECG parameters, including the QT interval, it was shown that the repolarization of the ventricles was prolonged. It was also noted that the results of these studies indicate inhibition of hERG channels with a low safety margin in humans, which indicated the possibility of similar results when using the drug in patients at the maximum recommended and higher doses.

According to the obtained safety data in terms of the ratio of benefits and risks of fenspiride, the marketing authorization holder proposes to withdraw their fensperide-based drugs from the market.

According to the WHO Center for International Monitoring of Medicines for Fenspiride, there are about 600 reports of side effects, including cardiac disorders in the form of: tachycardia, sinus tachycardia, extrasystole, ventricular fibrillation, supraventricular tachycardia, arrhythmias, paraxysmal tachycardia, rhythm disturbances according to torsade de pointes ”, spasm of the coronary arteries, bradycardia, flutter of the heart, cardiomyopathy and infectious myocarditis.

In this context, as a precautionary measure, the marketing authorization holder decides to apply for the revocation of the marketing authorization of fenspiride worldwide.

Medicinal product with the active ingredient fenspiride registered in the Republic of Uzbekistan from a number of foreign companies.

In this regard, the Pharmacological Committee sent the above information to all manufacturers who have registered drugs with the active ingredient fenspiride in the Republic of Uzbekistan, with a request to notify the Pharmacological Committee of the decision.

Received from the companies "Polpharma S.A." (Poland), "Les Laboratoires Servier" (France) on the revocation of registration certificates for the drugs "Erespal" coated tablets 80 mg, "Erespal" syrup 150 ml and "Sirep" syrup 2 mg / ml 150 ml ". By the decision of the expert council of the State Unitary Enterprise "State Center for Expertise and Standardization of Medicines, Medical Products and Medical Equipment" dated February 18
2019 (Protocol No. 5) of the registration certificate for these drugs were canceled and excluded from the Register of Medicines, medical devices and medical equipment permitted for use in medical practice in the Republic of Uzbekistan.

We also received reports from Gedeon Richter (Hungary) on the actions of the regulatory body in relation to decision-making on the EPISTAT® (fenspiride) extended-release tablets, film-coated 80 mg.

At present, information is expected from other companies (JSC "Galichpharm" (Ukraine) PJSC "Kievmedpreparat"; "Zentiva Saglik Urunleri Sanayi ve Ticaret AS" (Turkey) "World Medicine Ilac San. Ve Tic. AS" (Turkey) "Glenmark Pharmaceuticals Ltd "(India)), on which appropriate decisions will also be made.