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Pregnancy in acromegaly patients treated with pegvisomant.
- Source :
-
Endocrine [Endocrine] 2015 Aug; Vol. 49 (3), pp. 769-73. Date of Electronic Publication: 2014 Dec 27. - Publication Year :
- 2015
-
Abstract
- To summarize all available data on pregnancy outcome of acromegaly patients exposed to the growth hormone receptor antagonist pegvisomant (PEGV) during pregnancy as present in the Pfizer's Global Safety Database. Pfizer's Global Safety Database contains adverse event data obtained from the following sources: spontaneous reports, health authorities, Pfizer-sponsored post-marketing surveillance program (ACROSTUDY), customer engagement programs, and clinical studies, reported regardless of outcome. The safety database was searched up to 10th March 2014. From the 35 pregnancy cases, 27 involved maternal [mean age (range) 33.3 years (23-41) and 8 paternal (33.7 years (32-38)] PEGV exposure. Two female patients were reported with two pregnancy cases each. Fetal outcome was normal in 14 (4 paternal) of the 18 reported as live birth, while 4 cases (1 paternal) did not specify the birth outcome. At conception, PEGV mean dose (range) was 15.3 mg/d (4.3-30). In 3 cases of maternal exposure of the 18 cases reporting live birth, PEGV was continued throughout the pregnancy in a dose of 12.1 mg/d (10-15). In 5 cases (all maternal) an elective termination of the pregnancy was performed with no reported fetal abnormalities, 2 cases (maternal) reported a non-PEGV-related spontaneous abortion and in 1 maternal case an ectopic pregnancy occurred. In 9 cases (3 paternal), the fetal outcome was not reported. Three women reported gestational diabetes; one woman continued PEGV treatment during pregnancy. Although the number of reported pregnancies with exposure to PEGV is very small, the presented data reflect the largest series of data available to date and do not suggest adverse consequences of PEGV on pregnancy outcome. Nevertheless, it should be stressed that PEGV should not be used during pregnancy unless absolutely necessary.
- Subjects :
- Abnormalities, Drug-Induced epidemiology
Abortion, Spontaneous epidemiology
Adult
Databases, Factual
Fathers
Female
Hormone Antagonists adverse effects
Human Growth Hormone adverse effects
Human Growth Hormone therapeutic use
Humans
Infant, Newborn
Patient Safety
Pregnancy
Pregnancy Outcome
Pregnancy, Ectopic
Product Surveillance, Postmarketing
Young Adult
Acromegaly complications
Acromegaly drug therapy
ErbB Receptors antagonists & inhibitors
Hormone Antagonists therapeutic use
Human Growth Hormone analogs & derivatives
Pregnancy Complications therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1559-0100
- Volume :
- 49
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Endocrine
- Publication Type :
- Academic Journal
- Accession number :
- 25542184
- Full Text :
- https://doi.org/10.1007/s12020-014-0508-3