Bromocriptine
Risk Factor: CM
Class: MISCELLANEOUS
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
Fetal Risk Summary
Bromocriptine has been used during all stages of pregnancy. In 1982, Turkalj and coworkers (1) reviewed the results of 1,410 pregnancies in 1,335 women exposed to bromocriptine during gestation. The drug, used for the treatment of infertility as a result of hyperprolactinemia or pituitary tumors including acromegaly, was usually discontinued as soon as pregnancy was diagnosed. The mean duration of exposure after conception was 21 days. The review included all reported cases from 1973, the year bromocriptine was introduced, through 1980. Since then, 11 other studies have reported the results of treatment in 121 women with 145 pregnancies (2,3,4,5,6,7,8,9,10,11 and 12) . The results of the pregnancies in the combined studies are: Total patients/pregnancies 1,456/1,555 Liveborn infants 1,369 (88%) Stillborn infants 5 (0.3%) Multiple pregnancies (30 twins/3 triplets) 33*(2.1%) Spontaneous abortions
A total of 48 (3.5%) of the 1,374 liveborn and stillborn infants had detectable anomalies at birth (1,2). This incidence is similar to the expected rate of congenital defects found in the general population. In the review by Turkalj and coworkers, the mean duration of fetal exposure to bromocriptine was similar between children with congenital abnormalities and normal children. No distinguishable pattern of anomalies was found. Malformations detected at birth were as follows: Major Down's syndrome 2 Hydrocephalus and multiple atresia of esophagus and intestine 1 Microcephalus/encephalopathy 1 Omphalocele/talipes 1 Pulmonary artery atresia 1 Reduction deformities 4 Renal agenesis 1 Pierre Robin syndrome 1 Total
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 50 newborns had been exposed to bromocriptine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Three (6.0%) major birth defects were observed (two expected). Specific information was not available on the malformations, but no anomalies were observed in six categories of defects (cardiovascular defects, oral clefts, spina bifida, polydactyly, limb reduction defects, and hypospadias) for which data were available. Based on a small number of exposures, the data do not support an association between the drug and congenital defects.
In summary, bromocriptine apparently does not pose a significant risk to the fetus. The pattern and incidence of anomalies are similar to those expected in a nonexposed population.
Breast Feeding Summary
Since bromocriptine is indicated for the prevention of physiologic lactation, breast feeding is not possible during therapy (13,14). However, in one report, a mother taking 5 mg/day for a pituitary tumor was able to breast-feed her infant successfully (3). No effects on the infant were mentioned. Because bromocriptine suppresses lactation, the American Academy of Pediatrics considers the drug to be contraindicated during breast feeding (15).
References
- Turkalj I, Braun P, Krupp P. Surveillance of bromocriptine in pregnancy. JAMA 1982;247:158991.
- Konopka P, Raymond JP, Merceron RE, Seneze J. Continuous administration of bromocriptine in the prevention of neurological complications in pregnant women with prolactinomas. Am J Obstet Gynecol 1983;146:9358.
- Canales ES, Garcia IC, Ruiz JE, Zarate A. Bromocriptine as prophylactic therapy in prolactinoma during pregnancy. Fertil Steril 1981;36:5246.
- Bergh T, Nillius SJ, Larsson SG, Wide L. Effects of bromocriptine-induced pregnancy on prolactin-secreting pituitary tumors. Acta Endocrinol 1981;98:333.
- Yuen BH, Cannon W, Sy L, Booth J, Burch P. Regression of pituitary microadenoma during and following bromocriptine therapy: persistent defect in prolactin regulation before and throughout pregnancy. Am J Obstet Gynecol 1982;142:6349.
- Maeda T, Ushiroyama T, Okuda K, Fujimoto A, Ueki M, Sugimoto O. Effective bromocriptine treatment of a pituitary macroadenoma during pregnancy. Obstet Gynecol 1983;61:11721.
- Hammond CB, Haney AF, Land MR, van der Merwe JV, Ory SJ, Wiebe RH. The outcome of pregnancy in patients with treated and untreated prolactin-secreting pituitary tumors. Am J Obstet Gynecol 1983;147:14857.
- Cundy T, Grundy EN, Melville H, Sheldon J. Bromocriptine treatment of acromegaly following spontaneous conception. Fertil Steril 1984;42:1346.
- Randall S, Laing I, Chapman AJ, Shalet SM, Beardwell CG, Kelly WF, Davies D. Pregnancies in women with hyperprolactinaemia: obstetric and endocrinological management of 50 pregnancies in 37 women. Br J Obstet Gynaecol 1982;89:2033.
- Andersen AN, Starup J, Tabor A, Jensen HK, Westergaard JG. The possible prognostic value of serum prolactin increment during pregnancy in hyperprolactinaemic patients. Acta Endocrinol 1983;102:15.
- van Roon E, van der Vijver JCM, Gerretsen G, Hekster REM, Wattendorff RA. Rapid regression of a suprasellar extending prolactinoma after bromocriptine treatment during pregnancy. Fertil Steril 1981;36:17377.
- Crosignani P, Ferrari C, Mattei AM. Visual field defects and reduced visual acuity during pregnancy in two patients with prolactinoma: rapid regression of symptoms under bromocriptine. Case reports. Br J Obstet Gynaecol 1984;91:8213.
- Product information. Parlodel. Sandoz Pharmaceuticals, 1985.
- Thorbert G, Akerlund M. Inhibition of lactation by cyclofenil and bromocriptine. Br J Obstet Gynaecol 1983;90:73942.
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Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 1994;93:13750.
