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Endocrine

, Volume 49, Issue 3, pp 769–773 | Cite as

Pregnancy in acromegaly patients treated with pegvisomant

  • A. J. van der LelyEmail author
  • Roy Gomez
  • Joseph F. Heissler
  • Ann-Charlotte Åkerblad
  • Peter Jönsson
  • Cecilia Camacho-Hübner
  • Maria Kołtowska-Häggström
Original Article

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.

Keywords

Acromegaly Pregnancy Pegvisomant Treatment Complications 

Notes

Acknowledgments

ACROSTUDY is sponsored by Pfizer Inc.

Disclosure

AJvdL, received honoraria from Pfizer as member of the ACROSTUDY Strategic Advisory Board, CCH, RG, JH, A-CÅ, and PJ are permanent employees of Pfizer, MK-H was a full time employee at Pfizer Health AB when the work was done but now is an affiliate at the Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden.The authors were not paid for their contribution to this manuscript.

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • A. J. van der Lely
    • 1
    Email author
  • Roy Gomez
    • 2
  • Joseph F. Heissler
    • 3
  • Ann-Charlotte Åkerblad
    • 4
  • Peter Jönsson
    • 4
  • Cecilia Camacho-Hübner
    • 5
  • Maria Kołtowska-Häggström
    • 6
  1. 1.Depatment of Internal MedicineErasmus University MCRotterdamThe Netherlands
  2. 2.European Medical Affairs, PfizerBrusselsBelgium
  3. 3.Safety Surveillance & Risk ManagementPfizer Inc.New YorkUSA
  4. 4.Pfizer Endocrine CarePfizer Health ABSollentunaSweden
  5. 5.Endocrine CarePfizer Inc.New YorkUSA
  6. 6.Department of Women´s and Children´s HealthUppsala UniversityUppsalaSweden

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