pulmicort and Abortion--Spontaneous

Budesonide is the only inhaled corticosteroid to be given a category B pregnancy rating by the US Food and Drug Administration, based on observational data from the Swedish Medical Birth Registry. However, data from large randomized controlled trials are lacking.. To compare pregnancy outcomes among patients with recent-onset mild-to-moderate persistent asthma receiving low-dose budesonide vs placebo.. In a randomized, double-blind, placebo-controlled trial, 7241 patients aged 5 to 66 years with mild-to-moderate persistent asthma for less than 2 years and no previous regular corticosteroid therapy received once-daily budesonide or placebo via dry powder inhaler in addition to their usual asthma medication for 3 years. This trial was followed by a 2-year open-label treatment period. The daily dose of budesonide was 400 microg for adults. The study included 2473 females aged 15 to 50 years at randomization. Pregnancy was not an exclusion criterion (except for U.S. patients).. Of 319 pregnancies reported, 313 were analyzed. Healthy children were delivered in 81% and 77% of all pregnancies in the budesonide and placebo groups, respectively. Of the 196 pregnancies reported by participants taking budesonide, 38 (19%) had adverse outcomes: 23 (12%) had miscarriages, 3 (2%) had congenital malformations, and 12 (6%) had other outcomes. Of the 117 pregnancies reported in the placebo group, 27 (23%) had adverse outcomes: 11 (9%) had miscarriages, 4 (3%) had congenital malformations, and 12 (10%) had other outcomes.. Treatment with low-dose inhaled budesonide in females with mild-to-moderate persistent asthma does not seem to affect the outcome of pregnancy.

Topics: Abortion, Spontaneous; Adolescent; Adult; Asthma; Bronchodilator Agents; Budesonide; Child; Child, Preschool; Congenital Abnormalities; Female; Humans; Middle Aged; Pregnancy; Pregnancy Outcome

16 alpha,17 alpha-Butylidenedioxy-11 beta,21-dihydroxy-pregna-1,4-diene-3,20-dione (budesonide), a newly developed glucocorticosteroid, was administered subcutaneously to pregnant rabbits at doses of 0.01, 0.06 and 0.29 mumol/kg during the organogenetic period. As a reference compound the glucocorticosteroid fluocinolone acetonide, at the dose 0.28 mumol/kg, was used. In the group given 0.06 mumol/kg 2 dams out of 15 aborted. All animals receiving 0.29 mumol/kg aborted. All dams receiving fluocinolone acetonide aborted. The food consumption was reduced in all groups given budesonide. The body weight change was dose-dependently reduced for the groups receiving budesonide. The group receiving fluocinolone acetonide also showed a negative body weight change compared with the control group. The affected litter parameters were: reduced litter and fetal weight in the groups receiving 0.01 and 0.06 mumol/kg of budesonide, indicating intrauterine growth retardation. Furthermore, the frequency of fetal abnormalities, mainly skeletal anomalies, was significantly increased in the group receiving 0.06 mumol/kg of budesonide. The anomalies seen were mostly different kinds of delayed development of the bones in the skull and at the vertebra. A direct teratogenic effect cannot be excluded but severe maternal toxic reactions may have contributed to the pregnancy outcome.

Topics: Abortion, Spontaneous; Animals; Body Weight; Budesonide; Eating; Female; Fetus; Fluocinolone Acetonide; Injections, Subcutaneous; Pregnancy; Pregnenediones; Rabbits; Teratogens