Korean J Obstet Gynecol.  2012 Jan;55(1):1-7. 10.5468/KJOG.2012.55.1.1.

Pregnancy outcomes after exposure to phendimetrazine in first trimester of pregnancy

• Lee MY
• Choi JS
• Han JY
• Ahn HK
• Yang JH
• Kim MY
• Ryu HM
• Kim MH
• Chung JH
• Choi KH
• Lee SW
• Han YJ
• Lee JR
• Park HW

• KMID: 1836756
• DOI: http://doi.org/10.5468/KJOG.2012.55.1.1

Abstract

OBJECTIVE
Phendimetrazine is an amphetamine analogue that acts as a sympathomimetic with anorectic properties, used for weight loss. There is scarce information on the safety of phendimetrazine associated with fetal anomaly when used early in pregnancy. Some studies suggested that use of phendimetrazine during pregnancy may increase the risk of cleft lip and palate, and congenital diaphragmatic hernia. The aim of the study was to evaluate fetal outcomes among pregnant women who were inadvertently exposed to phendimetrazine in early pregnancy.
METHODS
Total 62 singleton pregnant women who were inadvertently exposed to phendimetrazine during early pregnancy were prospectively followed up (twin pregnancy was excluded). In addition, 122 age and gravity matched pregnant women were not exposed to any potential teratogenic agent during pregnancy were recruited as controls.
RESULTS
Mean age of exposed women was 33.2 +/- 4.9 years, with mean gravity was 2.2 +/- 1.1 and mean gestational weeks at exposure was 4.2 +/- 2.0. All gestations were confirmed by ultrasonography. Of exposed women, 3 (1.0%) had spontaneous abortions, 2 had artificial abortion, 23 cases were lost to follow-up and 7 cases were transferred to other hospital. Therefore, 26 pregnancies inadvertently exposed to phendimetrazine were evaluated. Two babies had abnormal outcome: one had choroid plexus cyst, another baby had bilateral equinovarus. In control group, 11 babies were born with abnormal outcome (7.7% vs. 12.0%; P = 0.54; odds ratio, 0.61; 95% confidence interval, 0.12 to 2.96).
CONCLUSION
These preliminary results suggest that phendimetrazine may not pose substantial fetal risks. Although more information is needed, there is a critical need for further research on medication used during pregnancy.

Keyword

Phendimetrazine; Congenital malformations; Pregnancy

MeSH Terms

Abortion, Spontaneous
Amphetamine
Choroid Plexus
Cleft Lip
Clubfoot
Female
Gravitation
Hernia, Diaphragmatic
Humans
Lost to Follow-Up
Morpholines
Odds Ratio
Palate
Pregnancy
Pregnancy Outcome
Pregnancy Trimester, First
Pregnant Women
Prospective Studies
Weight Loss
Amphetamine
Hernia, Diaphragmatic
Morpholines

Figure

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  Fig. 1 Clinical course of pregnancy.

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