The adverse effects of cough and cold remedies (cough mixture, antihistamine, decongestants and bronchodilators) are disproportionate in relation to the natural course of these symptoms, which soon clear up of their own accord. This is confirmed by a study carried out by the US Food and Drug Administration (FDA). Oral cough remedies have similar effects to placebo but sometimes severe adverse effects: cardiac arrhythmia, stroke, convulsions, hallucinations, loss of consciousness and other neurological disorders.
In the USA, between 1969 and 2006, 123 deaths associated with cough and cold remedies occurred among children under the age of 6. Some cases were linked to over-the-counter drugs, and one-third were caused by errors (misleading brand names, confusion of names or packaging, dosage errors, etc.).
A French study of decongestants with vasoconstrictor agents confirmed the severe risks associated with them, especially cardiovascular, whereas these infections are benign and clear up of their own accord. Nearly 300 cases of cardiac disorder were reported, including myocardial infarction, and nearly 50 cases of neurological disorder, with 13 cases of stroke.
These drugs should be removed from sale. Doctors and pharmacists should not prescribe or supply them, and patients should not use them.
©Prescrire November 2009
Source: "Médicaments de la toux et du rhume : des effets indésirables trop graves face à des troubles bénins" Rev Prescrire 2009; 29 (312): 751-752.