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Sale of fenspiride medicines in Azerbaijan banned

09 April 2019 13:50 (UTC +04:00)

Import, retail, and wholesale of fenspiride medicines is suspended in Azerbaijan, Analytical Expertise Center of Azerbaijan's Ministry of Health told ONA.

It is stated that on February 15, the European Medicine Agency (EMA) adopted a document entitled "Suspension of fenspiride medicines due to the potential risk of heart rhythm problems."

All series of fenspiride containing medical products have been recalled in order to protect the health of the population and the patients from potential risks during the ongoing research:

№	Name of the medicine	BPA və dose	Forma və commercial packaging	Manufacturer company, country
1	Erespal	fenspiride hydrochloride 10 mg/5 ml	syrup 100 ml bottle №1, cardboard packing	Les Laboratoires Servier İndustrie, France
2	Erespal	fenspiride hydrochloride 80mg	coated tablets №30	Les Laboratoires Servier İndustrie, France
3	Tirfens	fenspiride hydrochloride 2 mg/ml	syrup 100 ml bottle №1, cardboard packing, coated tablets №28	World Medicine İlaç Sanayi ve Ticarət A.Ş., Turkey
4	Tirfens	fenspiride hydrochloride 80 mg	coated tablets №20 (10x2), №30 (10x3), cardboard packaging in blister	World Medicine İlaç San. ve Tic. А.Ş., Turkey

The suspension is a precautionary measure to protect patients while the PRAC reviews the risk of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances).

Cases of heart rhythm problems had been reported in patients who had taken these medicines in the past. To explore the potential link between fenspiride and these heart rhythm problems, animal studies were carried out which now show that fenspiride has the potential to prolong QT in humans.

Fenspiride medicines are available as syrup or tablets and used in adults and children from the age of 2 years to relieve cough resulting from lung diseases.