Vasoconstrictive Decongestants: the Authorities’ Poisoning in Children

Adverse Effects

Editors’ Opinion Translated from Rev Prescrire January 2013; 33 (351): 25 Translated from Rev Prescrire February 2013; 33 (352): 103 Vasoconstrictive drugs: Vasoconstrictive decongestants: the authorities’ poisoning in children

dithering leaves patients in danger FDA review.

The cardiovascular and neurological criminately to all vasoconstrictors. How- In October 2012 the U.S. adverse effects of vasoconstrictive ever, it could be applied to certain prod- Food and Drug Administra- decongestants (ephedrine, naphazoline, ucts prone to misuse” (our translation) tion published an analysis of oxymetazoline, phenylephrine, pseudo- (4,6). 96 cases of accidental ephedrine and tuaminoheptane) used to While measures aimed at limiting mis- ingestion of vasoconstrictive nasal decon- relieve symptoms of the common cold use of medicines are welcome, they are gestants and eyedrops by children, report- are well known (1,2). In France, nasal in no way sufficient in the present case. ed between 1985 and 2012. The drugs preparations have been placed on List II Patients must be protected from the life- involved were intended for the relief of of moderately dangerous substances threatening adverse effects of vasocon- nasal congestion or ocular hyper- and are therefore available by prescrip- strictive decongestants used to treat aemia (1). tion only, while oral forms are available simple colds, and simple market with- The ingested substances were tetry- without a prescription. drawal is the best option. zoline, oxymetazoline or naphazoline Since the 1990s, several pharmaco- This procrastination further illustrates (combined with methylthioninium chlo- vigilance reports on these drugs have ANSM’s incapacity to take timely deci- ride in eye drops and with prednisolone in been published in France, and all have sions on drug safety and thereby to ful- nasal solution). The children were aged given similar results regarding serious fil its primary mission: to protect patients. from 1 month to 5 years (1). 53 children and even fatal adverse effects such as Prescrire were hospitalised because of nausea, myocardial infarction and stroke, some- vomiting, lethargy, tachycardia, respiratory times in young patients. In addition, disorders, bradycardia, arterial hypoten- a- In 2001, phenylpropanolamine, an amphetamine-like these reports show that adverse effects vasoconstrictor, was placed on List I of dangerous sub- sion or hypertension, sedation or drowsi- are more frequent with oral forms than stances, after opinions concluding (our translation) that ness, mydriasis, stupor, hypothermia, “the beneﬁts of phenylpropanolamine are minor consid- with nasal forms; that the recommended ering the very low but severe risk of haemorrhagic stroke.” hypersalivation, or coma. No deaths treatment periods and maximum doses Products containing this drug were subsequently with- occurred. are not respected; and that several med- drawn from the French market, or their composition was The children were found chewing, suck- changed (ref 7). ications containing vasoconstrictive ing or playing with a bottle, or an empty decongestants are often taken con- bottle was found nearby (1). The amount comitantly (2-4). Until early 2013, the 1- Prescrire Rédaction “Les effets indésirables sys- ingested, when specified, was between a main measures taken by the French témiques des vasoconstricteurs rhinopharyngés” few millilitres and one or even one-and- Rev Prescrire 1982; 2 (14): 24. health products agency (ANSM, formerly 2- Prescrire Editorial Staff “Vasoconstrictor: neu- a-half bottles (1). Afssaps) consisted of modifying the rological and cardiovascular adverse effects” Pre- Other published reports suggest that 12 SPCs and patient leaflets to limit the scrire Int 2003; (63): 21. ingestion of between 2 and 5 ml of 0.05% 3- Prescrire Rédaction “Décongestionnants ORL: duration of treatment and to add con- trop risqués en France aussi” Rev Prescrire 2009; 29 tetryzoline solution by a child is sufficient traindications and warnings (a)(4,5). (312): 752. to induce coma. Respiratory depression 4- Afssaps “Point d’information sur les déconges- In late 2012, after reviewing the results tionnants de la sphère ORL renfermant un vaso- and bradycardia have been observed in of the latest pharmacovigilance update, constricteur: information importante sur la sécurité children aged from 25 days to 2 years which yet again confirmed these dan- d’emploi et l’usage” 15 December 2011 + ANSM who ingested 1.5 to 3 ml of such a solu- “Point d’information sur les décongestionnants de gers, the ANSM National Pharmacovig- la sphère ORL renfermant un vasoconstricteur: tion. ilance Committee recommended that mise en garde de l’ANSM” 11 December 2012: Even though access to these products oral vasoconstrictive decongestants 4 pages. is easier in the USA, the severity of these 5- Prescrire Rédaction “Décongestionnants vaso- become subject to compulsory medical constricteurs et risques cardiovasculaires: com- paediatric cases is a further reason not to prescription. On 7 January 2013, this pléter les RCP ne suffit pas” Rev Prescrire 2011; 31 use decongestants. Indeed, in addition to (335): 660. recommendation, that only sought to 6- Agence de Presse Médicale “L’ANSM réticente their serious cardiovascular adverse limit the use of these drugs, had not à placer la pseudoéphédrine sous prescription oblig- effects in both adults and children, their atoire” 6 December 2012: 1 page. resulted in any effective action. Further- 7- presence in the home poses a serious “has no plans at this time Prescrire Rédaction “Phénylpropanolamine: pré- more, ANSM parations définitivement interdites” Rev Prescrire danger for children (2). Vasoconstrictive to apply this measure broadly and indis- 2001; 21 (222): 751. nasopharyngeal decongestants should simply be taken off the market. ©Prescrire

Selected references from Prescrire’s literature search. 1- U.S. Food and Drug Administration “FDA drug safety communication: serious adverse events from accidental ingestion by children of over-the-coun- ter eye drops and nasal sprays” 25 October 2012. www.fda.gov accessed 5 November 2012: 4 pages. 2- Prescrire Rédaction “SMR “insuffisant” et dérem- boursements: des incohérences. Décongestionnants vasoconstricteurs” Rev Prescrire 2012; 32 (348): 738.

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