[Adverse cardiovascular and central neurologic reactions to sympathomimetics used as nasal decongestants: results of the French National Pharmacovigilance Survey].
Remedies for coughs and colds often contain both an indirect sympathomimetic agent plus another drug (anti-inflammatory, analgesic or antibiotic, etc.). In France, oral sympathomimetics are available over the counter, and preparations for topical use (nasal sprays or drops) require a medical prescription. Using the French Pharmacovigilance database, we performed a retrospective study to identify cardiovascular and neurological adverse drug reactions (ADRs) associated with the use of nasal decongestants containing a sympathomimetic agent. Of a total of 165 ADRs. 15 were strokes or cerebral haemorrhages. We also found the following: 67 cases of arterial hypertension, 33 of convulsions, 28 of headaches and 24 of vasomotor symptoms involving the extremities. In most of these cases, misuse or a predisposing factor was found (such as a history of arterial hypertension or headache, the combination of two decongestants, long-term use, etc.). The incidence of cardiovascular or neurological ADRs with cold remedies seems 'very rare' but some of these reactions, mainly stroke, are 'serious'. However, there is no available clinical evidence showing the benefit of such agents after repeated use over several days. Since most of the nasal decongestants are freely available without prescription, drug information is needed to advise prescribers and also patients about risk of 'serious' ADRs with these drugs.
Olivier
Pascale
P
Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire de Toulouse, Faculté de Médecine de Toulouse, Toulouse, France. olivier@cict.fr
Dugué
Aurelie
A
Montastruc
Jean-Louis
JL
D000281:Administration, Intranasal; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000453:epidemiology; D002561:Cerebrovascular Disorders / Q000139:chemically induced; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D014663:Nasal Decongestants / Q000009:adverse effects*; D009422:Nervous System Diseases / Q000139:chemically induced* / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D012640:Seizures / Q000139:chemically induced; D013566:Sympathomimetics / Q000009:adverse effects*
D014663:Nasal Decongestants; D013566:Sympathomimetics