§ Dr. TongeTo ask the Secretary of State for Health (1) what reports he has received on reactions to over-the-counter drugs containing pseudoephedrine hydrochloride; [22471]
(2) what plans he has to issue revised guidance to patients from manufacturers on over-the-counter drugs containing pseudoephedrine hydrochloride. [22472]
§ Ms BlearsPseudoephedrine hydrochloride (a decongestant) has been an ingredient of many over-the-counter (OTC) cold and flu remedies for many decades. There have been 757 suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) through the yellow card scheme in association with pseudoephrine containing products since 1965.
The most commonly reported suspected ADRs with pseudoephedrine hydrochloride are allergic reactions (skin rash, facial swelling), cardiovascular reactions (increased or irregular heart rate), psychiatric reactions (depression and hallucinations), difficulty in passing urine, headache, insomnia, nightmares, nausea and vomiting. It is important to note that a report of a suspected ADR does not necessarily mean that it was caused by the drug and underlying conditions or concomitant medications may be implicated.
Guidance on the use and side effects of medicines is provided to patients in the Patient Information Leaflet (PIL) which accompanies the medicine. The Medicines Control Agency and the CSM continually monitor the safety of all medicines to ensure that the product information contains appropriate and up-to-date guidance on safe, correct use at the recommended dose and warnings about side effects.