title: Pregnancy in acromegaly patients treated with pegvisomant.
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.
authors.affiliation: Depatment of Internal Medicine, Erasmus University MC, P.O.Box 2040, 3000 CA, Rotterdam, The Netherlands, a.vanderlelij@erasmusmc.nl.
authors.forename: A J
authors.initials: AJ
authors.lastname: van der Lely
authors.forename: Roy
authors.initials: R
authors.lastname: Gomez
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Heissler
authors.forename: Ann-Charlotte
authors.initials: AC
authors.lastname: Åkerblad
authors.forename: Peter
authors.initials: P
authors.lastname: Jönsson
authors.forename: Cecilia
authors.initials: C
authors.lastname: Camacho-Hübner
authors.forename: Maria
authors.initials: M
authors.lastname: Kołtowska-Häggström
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000022:Abortion, Spontaneous / Q000453:epidemiology; D000172:Acromegaly / Q000150:complications* / Q000188:drug therapy*; D000328:Adult; D016208:Databases, Factual; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D005220:Fathers; D005260:Female; D006727:Hormone Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D019382:Human Growth Hormone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007231:Infant, Newborn; D061214:Patient Safety; D011247:Pregnancy; D011248:Pregnancy Complications / Q000628:therapy*; D011256:Pregnancy Outcome; D011271:Pregnancy, Ectopic; D011358:Product Surveillance, Postmarketing; D055815:Young Adult
chemical_list: D006727:Hormone Antagonists; D019382:Human Growth Hormone; D066246:ErbB Receptors; C406545:pegvisomant