Isotretinoin, pregnancies, abortions and birth defects: a population‐based perspective
Notice bibliographique
Résumé
What is already known about this subject • As of now, no population‐based data exist on the incidence of pregnancy, elective abortions, and birth defects while on isotretinoin. • From surveys or interventional studies, it is known that pregnancy rates while on isotretinoin are comparable to the baseline rate, and that birth defect rates associated with first‐trimester exposure are 10 times greater than in the general population. • Given that women decide to terminate pregnancies based on the available data, population‐based estimates are needed. What this study adds • This first non‐interventional population‐based study on the risk of pregnancy while being exposed to isotretinoin has shown that the rate of pregnancy is four times greater than what has been published to date (32.7/1000 person‐years). • Any pregnancy while using isotretinoin is the result of a failure of pregnancy prevention strategies, hence, thus far, pregnancy prevention programmes have failed. • The rate of elective abortions is much higher than previously reported (84%). • Women of a lower socio‐economic level and high users of healthcare services are more likely to become pregnant while on isotretinoin, suggesting that high use of health services increase the opportunity of having a prescription for isotretinoin or of having a pregnancy diagnosis. Aims To estimate the population‐based incidence rates of pregnancy, spontaneous and elective abortions, and birth defects associated with isotretinoin use, and to determine predictors of pregnancy while on isotretinoin. Methods Using the RAMQ (medical and pharmaceutical data), MED‐ECHO (hospitalizations) and ISQ (births and deaths) databases for the period 1984–2002, a cohort of 8609 women between 13 and 45 years of age and with a first prescription for isotretinoin (date of entry in the cohort) was identified. Women were eligible if they were insured by RAMQ for their medications at least 12 months before entry in the cohort and until 1 month after the end of their isotretinoin treatment. Pregnancies, spontaneous and elective abortions, and birth defects were identified using procedure codes and medical diagnoses. Results Of the 8609 women included, 90 became pregnant, an annual incident pregnancy rate during isotretinoin treatment of 32.7 per 1000 person‐years of treatment (95% confidence interval 26.6, 40.1). Of the 90 women who became pregnant while on the drug, 76 terminated the pregnancy (84%), three had a spontaneous abortion (3%), two had trauma during delivery resulting in neonatal deaths (2%) and nine had a live birth (10%). Among the live births, only one had a congenital anomaly of the face and neck (11%). Adjusting for potential confounders, predictors of becoming pregnant while on isotretinoin were lower socio‐economic level, one or more visits to the doctor or to the emergency department, or one or more hospitalization while on isotretinoin; concomitant isotretinoin and oral contraceptive use had a preventive effect. Conclusions This first non‐interventional population‐based study generated incidence rates of pregnancy while on isotretinoin four times greater than what has been reported in the literature thus far; elective abortion rates were also much higher in our study. This shows the importance of using population‐based data for public health purposes.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,004 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,003 | 0,003 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».