(Reuters) – The European Medicines Agency’s (EMA) safety committee on Friday recommended changes to product information for all medicines that contain the ingredient pseudoephedrine to address safety concerns related to neurological and heart-related side effects.
The health regulator started a review of decongestant medicines for cold and flu in February, after reports of conditions affecting blood vessels in the brain in some patients who took pseudoephedrine-containing medicines.
The committee recommends inclusion of risks related to the neurological conditions in the product information and warns it should not be used in certain patients with high blood pressure.
Pseudoephedrine is a drug used alone or in combination with other medicines to treat a blocked nose due to cold, flu or allergy.
Makers of pseudoephedrine-containing drugs include Reckitt Benckiser, McNeil Products Ltd and Organon & Co.
(Reporting by Pratik Jain in Bengaluru; Editing by Krishna Chandra Eluri)
