AIFA informs that the medicinal Questran®, in the formulation in sachets of 4 g powder for oral suspension (AIC 023014018), is no longer deficient in the national territory, according to what was communicated by the company that is the holder of the Marketing Authorization.
In order to protect public health and in consideration of the fact that the shortage has also affected the other countries where Questran® is marketed, the Italian Drug Agency has nonetheless ordered the temporary block of exports of all the packaging of the medicine, for guarantee the availability of sufficient quantities to meet the care needs of all patients.
The Questran®, containing the active ingredient cholestyramine hydrochloride, belongs to the class of drugs known as bile acid sequestrants and is indicated to decrease blood cholesterol levels in patients with primary hypercholesterolemia, with hypercholesterolemia associated with hypertriglyceridemia when the former is the problem main therapeutic, in patients who do not respond to dietary treatment alone and also to reduce the itching associated with partial blockage of the biliary tract.
The Marketing Authorization Holder (AIC) is the pharmaceutical company Cheplapharm Arzneimittel GMBH, which markets it in Italy, Belgium, Germany, France, the United Kingdom, the Netherlands, Argentina and Brazil. The AIFA and Cheplapharm Arzneimittel GMBH are in constant contact for the resolution of any problems related to achieving maximum capillarity in the distribution throughout the national territory of the packages now available.
Following the previous state of deficiency, for a short initial period a high demand could be generated for the packages now available. Therefore, the Agency recommends a conscious approach to the acquisition of the medicine and urges to avoid the rush to supply.