title: [Drug Shortage May Have Serious Outcome: the French Exemple of Phenytoine].
abstract: In 2012, in France, phenytoin sodium was used as a substitute for phenytoin base during a shortage at the dose of 100 mg for 100 mg, according to the French Health Agency recommendations. However, this substitution was problematic because the two specialties were not bioequivalent. We report here the case of a 29-year old woman who presented with severe epilepsy. The substitution of phenytoin base by phenytoin sodium induced an increase of seizure frequency leading to several hospitalizations and sick leave. Phenytoin base was finally available again in 2013 which allowed a reduction of seizure frequency. Six similar cases, including one death, were reported to the French pharmacovigilance system. Drug shortages are increasingly common and can have serious consequences. Reporting the difficulties that drug shortage causes to health authorities is important in order to improve their management and to better support patients.
authors.affiliation: Centre Régional de Pharmacovigilance, CHRU, Lille, France.
authors.forename: Marine
authors.initials: M
authors.lastname: Auffret
authors.affiliation: Service de Neurophysiologie Clinique, CHRU, Lille, France.
authors.forename: Louise
authors.initials: L
authors.lastname: Tyvaert
authors.affiliation: Centre Régional de Pharmacovigilance, CHU, Limoges, France.
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Laroche
authors.affiliation: Service de Neurologie, CHU, Limoges, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Godet
authors.affiliation: Service de neurologie, CHU, Saint-Etienne, France.
authors.forename: Roland
authors.initials: R
authors.lastname: Peyron
authors.affiliation: Centre Régional de Pharmacovigilance, CHU, Saint-Etienne, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Guy
authors.affiliation: Centre Régional de Pharmacovigilance, CHU, Bordeaux, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Géniaux
authors.affiliation: Centre Régional de Pharmacovigilance Saint Vincent de Paul, AP-HP, Paris, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Pécriaux
authors.affiliation: Centre Régional de Pharmacovigilance de Nice, CHU, Nice, France.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Baldin
authors.affiliation: Centre Régional de Pharmacovigilance, CHRU, Lille, France.
authors.forename: Johana
authors.initials: J
authors.lastname: Béné
authors.affiliation: Centre Régional de Pharmacovigilance, CHRU, Lille, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Gautier
mesh_terms: D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use*; D057915:Drug Substitution / Q000009:adverse effects*; D004827:Epilepsy / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D005602:France; D006297:Health Services Accessibility; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D010672:Phenytoin / Q000627:therapeutic use*; D017211:Treatment Failure; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D010672:Phenytoin