Among the medicines included in the warning are Actifed Rhume, Doliruhm Paracetamol, Pseudoephedrine, and Humex Rhume, among others.
France’s National Agency for the Safety of Medicines and Health Products (ANSM) has cautioned against the use of common nasal decongestants containing pseudoephedrine due to a potential risk of stroke or heart attack associated with them.
Christelle Ratignier-Carbonneil, the director of ANSM, emphasized the message, stating, “The message is clear. Do not use them. We do not risk getting a stroke for a stuffy nose.”
Among the medicines included in the warning are Actifed Rhume, Doliruhm Paracetamol, Pseudoephedrine, and Humex Rhume, among others. These medications are available in the form of oral tablets without a prescription or as a nasal spray with a prescription, according to ANSM.
In the UK, the active ingredient is marketed under various brand names such as Sudafed, Galpseud, Boots Decongestat, and Care Decongestant.
Pseudoephedrine functions by constricting the blood vessels in the nasal passages, but it can also have a similar effect on blood vessels in other parts of the body, potentially leading to an increase in blood pressure and heart rate.
The French medicines agency revealed that a comprehensive review of these medicines is currently underway at the European level. As an alternative to nasal decongestants, ANSM recommends nasal humidification with salt water spray, sleeping with an elevated head position, adequate fluid intake, and proper ventilation of living spaces.
Ratignier-Carbonneil further emphasized the goal of eventually discontinuing the sale of medicines containing pseudoephedrine in pharmacies.
Pseudoephedrine has faced increased regulation in some countries, including restrictions in the UK in 2007 and 2008 due to its potential for illegal use in the production of methylamphetamine.
In recent developments, another active ingredient, phenylephrine, used as a replacement for pseudoephedrine in some nasal decongestants, has been deemed ineffective by U.S. regulators.
However, the French pharmaceutical lobby NèreS, representing companies producing over-the-counter medicines, argued that ANSM’s warning was “premature and alarmist.” The lobby acknowledged its participation in the safety re-evaluation but noted that the full report had not yet been published.