Uzbek Health Ministry suspends registration certificates for products, containing fenspiride
14/03/2019 20:38
Uzbek Health Ministry suspends registration certificates for products, containing fenspiride
14/03/2019 20:38
Tashkent, Uzbekistan (UzDaily.com) -- State Unitary Enterprise “State Center for Expertise and Standardization of Medicinal Products, Medical Products and Medical Equipment” received information on the results of studies on the pharmacological safety of the medicinal product Fenspiride in vitro experiments on the assessment of the balance between benefits and risks on the state of the conductive system heart channels hERG.
In particular, in experiments on isolated and perfused guinea pig hearts by measuring ECG parameters, including the QT interval, lengthening of ventricular repolarization was shown. 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 regarding the ratio of benefits and risks of fenspiride, the holder of the registration certificate proposes to withdraw products based on fensperid from the market.
According to the WHO Center for International Monitoring of Drugs 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, arrhythmia, paraxysmal tachycardia, rhythm disorder torsade de pointes, spasms of the coronary arteries, bradycardia, heart flutter, cardiomyopathy and infectious myocarditis.
In this context, as a precautionary measure, the registration certificate holder decides to apply for the withdrawal of a permit for the sale of fenspiride worldwide.
Medicinal products with the active component fenspirid registered in the Republic of Uzbekistan from a number of foreign companies.
In this regard, the Pharmacological Committee sent information to all manufacturers, who have registered drugs with the active substance fenspirid in the Republic of Uzbekistan, with a request to notify the Pharmacological Committee of their decision.
Polpharma SA (Poland), Les Laboratoires Servier (France) decided to revoke registration certificates for Erespal 80 mg coated tablets, Erespal syrup 150 ml and Siresp syrup 2 mg / ml 150 ml. The medicaments were removed from the Register of Medicinal Products permitted for use in medical practice in the Republic of Uzbekistan.
The Uzbek body also received information from Gedeon Richter (Hungary) about the actions of the regulatory authority in relation to decision-making on the drug “EPISTAT®” (fenspiride) tablets of prolonged action, coated with a film shell of 80 mg.
The body is waiting for responses of Halychpharm, Kyivmedpreparat, Zentiva Saglik Urunleri Sanayi ve Ticaret AS, World Medicine Ilac San. Ve Tic. AS, Glenmark Pharmaceuticals Ltd.
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