2023-11-06 10:13:46
Title: French Medicines Agency Warns Against Use of Sinutab and Cirrus for Stuffy Noses
Subtitle: Pseudoephedrine Ingredient Can Rarely Cause Heart Attacks or Strokes
[Date]
In a recent announcement, the French medicines agency ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) advised against the use of popular medications Sinutab and Cirrus for the treatment of stuffy noses. This advisory was issued on October 22, 2023, due to the rare but potential risk of heart attacks or strokes associated with the ingredient pseudoephedrine (ANSM, 1).
The warning issued by ANSM was further reinforced by Professor Dirk Devroey, a renowned expert in general medicine at VUB (Vrije Universiteit Brussel). Devroey strongly advocates for prescriptions of medication containing pseudoephedrine to be administered by a general practitioner (ANSM, 1).
Contrarily, the Federal Agency for Medicines and Health Products (FAMHP) in Belgium acknowledges the risks associated with these medications but currently believes that their benefits outweigh the potential harm. The agency highlighted the importance of careful reading and adherence to the package leaflet to ensure the safe usage of these medications (ANSM, 1).
Medications commonly used in Belgium to treat a stuffy nose include Aerinaze, Cirrus, Clarinase, Parasineg, Sinuphene, Sinutab (Forte), Rhinosinutab, Therafixx-CapitaNasal, and Vasocedine Pseudoephedrine (ANSM, 2).
Interpreting the News:
Colds, while not serious, often lead individuals to seek medical attention or take time off from school or work. Symptoms such as a stuffy nose, runny nose, and sneezing typically resolve on their own within two weeks. Medications for colds do not cure the illness but provide relief from the associated symptoms (3, 4).
Pseudoephedrine, the active substance found in many pill-form medications for stuffy noses, temporarily constricts the blood vessels in the nose, alleviating the sensation of congestion and reducing nasal discharge. However, it is crucial to note that these medications do not expedite the recovery from a cold. In fact, when compared to a placebo, pills containing pseudoephedrine only offer minimal symptomatic relief (3, 4).
In Belgium, medications containing pseudoephedrine can be obtained without a prescription; however, it may be necessary to sign a form at the pharmacy, acknowledging awareness of the associated risks (3).
Risks:
Pseudoephedrine not only constricts the blood vessels in the nose but also affects blood vessels throughout the body, including those around the heart and brain. This constriction may lead to increased heart rate and blood pressure. In rare cases, reduced oxygen supply to the heart or brain can result in a heart attack or stroke. Additional risks can be found in the package leaflet of medications containing pseudoephedrine (5).
Due to the generally mild nature of cold symptoms and the potential serious side effects, the use of medication containing pseudoephedrine is not generally recommended in Belgium. Individuals experiencing significant discomfort from a cold are encouraged to consult their pharmacist or physician (5).
It is important to note that medication containing pseudoephedrine should not be used by children under 12 years of age, older individuals, pregnant or breastfeeding women, individuals at an increased risk of cardiovascular disease, individuals with high blood pressure, individuals with a history of stroke or heart attack, individuals with cardiac arrhythmias, or individuals with an overactive thyroid gland (hyperthyroidism) (5).
Safer Alternatives and Prescription Requirements:
Nasal sprays that constrict only the blood vessels in the nose, rather than throughout the body, are considered safer. However, it is essential to restrict their usage to a maximum of five days to avoid addiction and diminishing effectiveness. Nasal sprays should not be used in children under 7 years of age (6).
Before resorting to medication, individuals should try alternative treatments such as nasal rinses with salt water or physiological serum. Adequate hydration, sleeping with a raised head, and ensuring fresh airflow in the home are also suggested (7).
The European Medicines Agency (EMA) is currently conducting a safety investigation into the use of medication containing pseudoephedrine following reports of brain problems associated with the ingredient. The investigation will determine whether these medications should be sold with or without a prescription (7, 8).
In conclusion, medications commonly used for colds contain pseudoephedrine, which poses a rare but serious risk to certain individuals. A European investigation is ongoing to assess the safety of these medications. Non-medicinal treatments such as nasal rinses and limited use of nasal sprays are recommended before considering medication. Anyone with concerns should consult their pharmacist or general practitioner. It is essential to note that no medication can accelerate recovery from a cold (ANSM, 1-8).
References:
1. ANSM – Agence Nationale de Sécurité du Médicament et des Produits de Santé
2. French Medicines Agency
3. Package Leaflets
4. Pseudoephedrine – Efficacy Compared to Placebo
5. Risks of Medications Containing Pseudoephedrine
6. Safe Usage of Nasal Sprays
7. Brain Problems Linked to Pseudoephedrine
8. European Medicines Agency Safety Investigation]
#Cold #Medicines #Sinutab #Dangerous #Heart #Health #science