Sinutab and Fucidine will require prescription after health experts voice safety concerns
Starting 1 November, medicines containing the active ingredients pseudoephedrine and fusidic acid, such as Sinutab and Fucidine, will require a prescription in Belgium. The Federal Agency for Medicines and Health Products (FAMHP) made this announcement, citing concerns over serious side effects like cardiac arrhythmias, strokes and antibiotic resistance.
Pseudoephedrine, commonly found in cold medications like Sinutab, is known for its ability to quickly relieve nasal congestion by constricting blood vessels. However, this effect is not limited to the nose; pseudoephedrine can also narrow blood vessels in the brain and heart, potentially causing palpitations and more severe issues like heart attacks or strokes.
"For a healthy person, the risks are minimal, but for individuals with heart problems, it can be dangerous," warns Professor Dirk Devroey, a specialist in general medicine. Even a single tablet can trigger these side effects, which are not dose-dependent.
Fusidic acid, on the other hand, is used in creams and ointments to treat skin infections. Overuse can lead to antibiotic resistance, reducing the drug's effectiveness when it is needed most. Both ingredients are now subject to prescription to ensure proper use, with doctors assessing whether the drugs are suitable for each patient's medical history.
Calls for complete ban
Consumer group Testaankoop has called for a complete ban on pseudoephedrine-based medications like Sinutab, arguing that the risks outweigh the benefits. “Don't risk a stroke because of a blocked nose,” the organisation stated, stating that common cold symptoms will resolve on their own. The group is pushing for the removal of products that combine pseudoephedrine with paracetamol, such as Sinutab Forte and Therafixx-Capitanasal, citing the potential for serious side effects.
Professor Devroey agrees with the prescription requirement but is hesitant about a total ban. "Sometimes we are happy to prescribe it because it is effective," he explains, adding that the real issue is the improper distribution of these medicines to individuals who may have different medical profiles. This, he believes, leads to an increased risk of side effects.
The FAMHP also highlights the importance of careful use. "With the mandatory prescription, we can ensure proper use and prevent misuse," says spokesperson Ann Eeckhout. Additionally, advertising for these medications will now be prohibited, as the prescription-only status makes promoting them illegal.
©BELGA PHOTO THIERRY ROGE
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