Sidelining a Side Effect of Long-Acting Contraceptives

2015 ◽  
Vol 93 (1) ◽  
Author(s):  
Charlotte Schubert
2021 ◽  
Vol 61 (1) ◽  
pp. 745-756 ◽  
Author(s):  
Li Li ◽  
Doanh Tran ◽  
Hao Zhu ◽  
Praveen Balimane ◽  
Gerald Willett ◽  
...  

Long-acting contraceptives are the most effective reversible contraceptive methods. Increasing patients’ access to these contraceptives may translate into fewer unintended pregnancies and lead to substantial individual and public health benefits. However, development of long-acting products can be complex and challenging. This review provides ( a) an overview of representative development programs for long-acting antipsychotics as cases for conceptual translation to long-acting contraceptives, ( b) several case examples on how modeling and simulation have been used to streamline the development of long-acting products, and ( c) examples of challenges andopportunities in developing long-acting contraceptives and information on how exposure-response relationships of commonly used progestins may enable regulators and developers to rely on prior findings of effectiveness and safety from an approved contraceptive to streamline the development of long-acting contraceptives. The US Food and Drug Administration is seeking assistance from stakeholders to provide data from studies in which pharmacokinetic and pharmacodynamic or clinical outcomes of hormonal contraceptives were evaluated and not previously submitted.


2020 ◽  
Vol 32 (4) ◽  
pp. 461-470
Author(s):  
Alexandra J. Edwards ◽  
Amy D. DiVasta ◽  
Sarah Pitts
Keyword(s):  

1996 ◽  
Vol 134 (4) ◽  
pp. 454-456 ◽  
Author(s):  
Etienne Delgrange ◽  
Dominique Maiter ◽  
Julian Donckier

Delgrange E, Maiter D, Donckier J. Effects of the dopamine agonist cabergoline in patients with prolactinoma intolerant or resistant to bromocriptine. Eur J Endocrinol 1996;134:454–6. ISSN 0804–4643 Cabergoline is a new long-acting ergoline derivative used to treat hyperprolactinaemia. Its effect was assessed in 10 patients (eight women and two men) with prolactinoma who were intolerant (group I; N = 7) or resistant (group II; N = 3) to bromocriptine. In group I, no side effect was observed on cabergoline therapy; two patients became pregnant and normoprolactinaemia was achieved in the five others. In group II, cabergoline was active and well-tolerated in two out of the three patients: one woman had three consecutive pregnancies; in another patient normoprolactinaemia was restored and the tumour shrank by 60%; in the third patient cabergoline was discontinued because of side effects and inefficacy. Thus, cabergoline appears to be an alternative of choice as treatment of hyper-prolactinaemic patients who are intolerant or resistant to bromocriptine. Julian Donckier, Internal Medicine and Endocrinology, University Hospital UCL of Mont-Godinne, B-5530 Yvoir, Belgium


The Lancet ◽  
1995 ◽  
Vol 346 (8976) ◽  
pp. 693
Author(s):  
PaulM. Rowe

Drugs ◽  
1983 ◽  
Vol 25 (6) ◽  
pp. 570-609 ◽  
Author(s):  
G. Benagiano ◽  
F.M. Primiero

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Maryam Amir ◽  
Monica Flores ◽  
Jorge Calles-Escandon

Abstract Background: Cabergoline and Bromocriptine are ergot derivative long-acting dopamine agonist that are very effective and well tolerated in patients with hyperprolactinemia. A rare and unwanted side effect of Bromocriptine is priapism, which has hardly ever been report in literature and it’s not cited under the medication insert. The underlying mechanism is not totally clear, but it is well known that dopaminergic pathways in the central nervous system are of importance for male sexual behavior and penile erection. Lesser is known about Cabergoline and priapism with only one case report in the literature (1). Clinical Case: A 65 yr old African American male with a past medical history significant for obesity, essential hypertension, and recent history of frontal headaches was found to have a pituitary macroadenoma. Brain MRI demonstrated 11 x 12 x 9 mm enhancing lesion within the right lateral sella turcica. The lesion extended laterally to abut the right cavernous ICA without vascular encasement or extension into the right temporal skull base. Prolactin level was 276.3 ng/mL (2.1-15.0 ng/mL). He was started on Cabergoline 0.5 mg weekly. 60 days after starting Cabergoline he presented to the ED with a painful penile erection lasting >12 hours. He did not take any Phosphodiesterase (PDE) inhibitors and had no other recent change in medications. He denied any history of sickle cell disease. His most recent dose of Carbergoline was the day prior to the ED visit. He was seen by a Urologist in the ED and confirmed to have a low flow Priapism and underwent aspiration of intracorporal bodies. He was discharged home on pseudoephedrine and pain medications. Carbergoline was discontinued. He has had no further episodes of Priapism since discontinuation of Cabergoline. Conclusion: The time between drug use and occurrence, absence of other offending medications or precipitating factors and no further priapism episodes once treatment was discontinued suggests a priapism as a rarely reported side effect of Cabergoline. (1) References: 1.E.de la Pena Zarzuelo, V. Hernandez Canas and C. Llorente Abarca, Department of Urology, Hospital Universitario Fundacion Alcorcon, Madrid, Spain


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