The Agency of Medicines and Medical Devices decided to stop the distribution and sale of drugs that contain fenspiride as an active substance. An order to this effect was made on February 15, IPN reports.
Among the withdrawn medicines are Epistat 80 mg (pills), Fenspirid-LF 80 mg (pills), Siresp 2 mg/ml (syrup) and Tirfens 80 mg (coated pills).
The decision to suspend the drugs that contain fenspiride and are used to treat cough caused by lung diseases in children and grownups was taken on the recommendation of the Pharmacovigilance Risk Assessment Committee in a move to protect patients while the Committee is reexamining the risk of appearance of heart rhythm problems.
Earlier this week, there were withdrawn the lots of Eurespal 2 mg/ml (syrup) and Eurespal 80 mg (pills). New preclinical studies (on animals) showed these medicines can cause heart rhythm problems.
