From November 1, popular medications for nasal congestion, such as Sinutab and Sinutab Forte, will only be available by prescription in Belgium. This measure, announced by the Federal Agency for Medicines and Health Products (FAMHP), concerns medicines containing pseudo-ephedrine and ephedrine.
The FAMHP justifies this new regulation by emphasizing that pseudo-ephedrine is not recommended in any guidelines for the treatment of colds. Additionally, its use is associated with potentially serious side effects, including cardiovascular, neurological, and psychiatric. Some of these risks are unpredictable and not dose-related. In addition, there is a risk of abuse or misuse of this substance due to its stimulating and appetite suppressant effects.
On the medical side, Professor Dirk Devroey, specialist in general medicine at the VUB, supports this measure. He explains that pseudoephedrine works by narrowing blood vessels, which helps reduce swelling of the vessels in the nose and makes breathing easier. However, this vasoconstrictor effect can also occur in other parts of the body, such as the heart and brain, leading to rare but serious side effects, such as cardiac arrhythmias, heart attacks and stroke.
At the same time, from November 1, medicines based on fusidic acid will also be subject to compulsory prescription. This decision is explained by the increase in the resistance of bacteria, in particular Staphylococcus aureus, to treatments based on fusidine in Belgium. Interestingly, Belgium was the only country in Europe where these drugs were still available without a prescription. In addition, all advertising for these products will be prohibited from this same date.
The announcement of this new regulation caused a sharp increase in Sinutab sales. According to the pharmaceutical distribution company Febelco, sales of this drug increased sixfold the day after the announcement. Since October 1, around 30% of Sinutab’s usual monthly volume has already been sold. This increase in demand is explained by consumer concern about the future restriction of these drugs, thus pushing for a form of preventive storage.
Finally, despite these new regulatory measures, certain voices are being raised, such as that of Test-Achats, which continues to call for a complete withdrawal of these medications due to the health risks. The organization says that the symptoms of a cold, such as nasal congestion, go away naturally so these medications are not essential.
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