Concomitant Use of Antipsychotics and Progestogens: An Increased Risk of Reporting Galactorrhea?

Aim/Objective: By using the French pharmacovigilance database, we described galactorrhea cases in women using both antipsychotics and progestogens and studied the potential drug-drug interaction (DDI) between those medications. Methods: In the French pharmacovigilance database, we included reports o...

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Bibliographic Details
Published in:Drug safety 2024-12, Vol.47 (12), p.1358-1358
Main Authors: Barus, Romain, De Canecaude, Claire, Schiro, Pauline, Damase-Michel, Christinea, Gaboriau, Louise, Nobile, Benedicte, Montastruc, François
Format: Article
Language:English
Subjects:
Antipsychotics
Birth control
Contraceptives
Drug interaction
Drug interactions
Olanzapine
Pharmacovigilance
Psychotropic drugs
Risk
Risperidone
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Summary:Aim/Objective: By using the French pharmacovigilance database, we described galactorrhea cases in women using both antipsychotics and progestogens and studied the potential drug-drug interaction (DDI) between those medications. Methods: In the French pharmacovigilance database, we included reports of galactorrhea in women taking both antipsychotics and progestogens contraceptives. Drugs might be registered as suspected or concomitant. To detect DDI, we performed 1) an additive model based on the calculation of three reporting odds ratio and 2) the omega (X) shrinkage which is the observed-to-expected ratio measure. In the additive model, the sum of the ROR associated with antipsychotics and progestogens had to be lower that the ROR of the combination to generate a signal. In the X model, the detection criterion is X025 [0. Results: Seven cases of galactorrhea were included. Mean age was 17 years old (IQR = 16.5-26.5). Progestogens implicated were: desogestrel (n = 1), etonogestrel extended-release (n = 3), and levonorgestrel (n = 3). Antipsychotics implicated were: risperidone (n = 2); olanzapine alone (n = 1) or with cyamemazine (n = 2), loxapine (n = 1), and zuclopenthixol (n = 1). In 3 cases, the adjunction of progestogens induced galactorrhea. Among those 3 cases, prolactinemia was increased in 2 of them (for the third, prolactinemia was unavailable). Concomitant use of antipsychotics and progestogens was associated with an increased risk of reporting galactorrhea (ROR = 86.3; CI95%[40.1-185.6]). Both additive model and X model (X = 1.6; X025 = 0.5) suggested a DDI regarding the risk of galactorrhea between antipsychotics and progestogens. Conclusion: In women, concomitant use of antipsychotics and contraceptives progestogens increased the risk of reporting galactorrhea. Clinicians should be aware of this potential DDI.
ISSN:0114-5916
1179-1942