Unexpected drug-induced Raynaud phenomenon: Analysis from the French national pharmacovigilance database.
OBJECTIVE
To estimate the association between exposure to medicinal products and Raynaud phenomenon.


METHODS
The study used the data of all adverse drug reactions notified to the French national pharmacovigilance database. All cases reported between 1st January 1995 and 10th December 2012 were selected. A case/non-case method was used to measure disproportionality of the association between drug exposure and Raynaud phenomenon. The cases concerned all observations involving Raynaud phenomenon. Non-cases comprised all other reports of adverse drug reactions over the same period.


CONCLUSIONS
Among the 307,128 adverse drug reaction reports selected from the French national pharmacovigilance database, 175 involved Raynaud phenomenon, most of them affecting women (61.1%). The mean age was 50.1 years, and 8% had a past medical history of Raynaud phenomenon. According to the summaries of product characteristics, 42.3% of these cases were exposed to drugs known to induce Raynaud phenomenon. Unexpected Raynaud phenomenons (unlisted in the summaries of product characteristics) were associated with exposure to drugs for which Raynaud phenomenons are published (interferons, ribavirin, gemcitabine) or for which Raynaud phenomenons are not published (hepatitis B vaccine, isotretinoin, leflunomide, hydroxycarbamide, rofecoxib, telmisartan, zolmitriptan).


CONCLUSIONS
The case/non-case method is usually used to generate signals. Further epidemiological studies are now necessary to confirm these findings.
Regional pharmacovigilance centre, Angers university hospital, 49933 Angers, France. Electronic address: bouquet.emilie@gmail.com.
Émilie
É
Bouquet
Department of internal and vascular medicine, Angers university hospital, 49933 Angers cedex 9, France.
Geoffrey
G
Urbanski
Department of internal and vascular medicine, Angers university hospital, 49933 Angers cedex 9, France.
Christian
C
Lavigne
Regional pharmacovigilance centre, Angers university hospital, 49933 Angers, France.
Pascale
P
Lainé-Cessac
D016907:Adverse Drug Reaction Reporting Systems; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011928:Raynaud Disease / Q000139:chemically induced* / Q000453:epidemiology*
Drugs adverse effects; Effets indésirables médicamenteux; Pharmacovigilance; Phénomène de Raynaud; Raynaud phenomenon