May 23 2022

Classification of the active ingredient alprazolam


Risk level in pregnancy: This medicine is classified as Category D.

Although have not been attributed congenital anomalies to the use of alprazolam during pregnancy, other malformations have been reported after drug exposure during the first trimester with other drugs of the same therapeutic group. Is assumed, therefore, that alprazolam has a similar risk that the remaining benzodiazepines

Human studies have shown risk to the fetus, although in some circumstances, potential benefits may outweigh the risks to the fetus and/or pregnancy. Alprazolam may be acceptable if needed in a life-threatening situation for pregnant woman and can not be used other drugs safer or these are ineffective.

Should be noted, however, that the use of benzodiazepines rarely is an urgent issue, so that the use of these drugs should be avoided al least during the first trimester.

No data are available on the placental transfer of alprazolam, but it appears that may accumulate in the fetus, like other drugs of the same group.

In pregnant rats vertebral anomalies have occurred, and increased incidence of fetal death after exposure to high doses alprazolam. Also have been detected abnormalities of neuropsychological and behavioral development.

A descriptive study analyzes the results of 30 patients who ingested dose of between 7.5 mg and 100 mg of alprazolam with suicidal purpose in the period 1984-1993. Of ten born alive, two had congenital anomalies. Six of the mothers took the drug between the sixth and twelfth week of pregnancy. One of the newborns had multiple birth defects, including gastroschisis associated with other less relevant, the other had pectus excavatum, although in this case the mother do not took the drug during the critical period.

The authors conclude that there are no cognitive differences, of physical development or other types among the children of mothers who attempted suicide compared to controls and no evidence of maternal or fetal toxicity [1].

According to the findings of another study, the available information is insufficient to determine whether the potential benefits outweigh the fetal risks of benzodiazepines, recommending to avoid using alprazolam during pregnancy [2].

Another observational study conducted between 1982 and 1990, which included 542 pregnancies, of which 411 could be followed, showed 13 babies malformed live births, 263 normal children and the rest were spontaneous or induced abortions. According to the authors, there were no more anomalies or fetal death than in the general population, but also remember that the small sample size does not allow to extrapolate conclusions [3].

Manufacturer has reported isolated cases of pyloric stenosis, umbilical hernia, short lingual frenulum and ankle abnormalities concurrently with maternal use of alprazolam.

There have been reports of neonatal withdrawal syndrome after fetal exposure to maternal drug doses equal to or greater than 1 mg/day, showing from the second day of life irritability and restlessness. The withdrawal of breastfeeding may exacerbate the syndrome.

References:

1. Gidai J, Acs N, B?nhidy F, Czeizel AE. An evaluation of data for 10 children born to mothers who attempted suicide by taking large doses of alprazolam during pregnancy.Toxicol Ind Health. 2008 Feb-Mar;24(1-2):53-60. Doi: 10.1177/0748233708089017.
2. Iqbal MM, Sobhan T, Ryals T. Effects of commonly used benzodiazepines on the fetus, the neonate, and the nursing infant. Psychiatr Serv. 2002 Jan;53(1):39-49.
3. St Clair SM, Schirmer RG. First-trimester exposure to alprazolam. Obstet Gynecol. 1992 Nov;80(5):843-6.

Update 18.07.2009

Meaning of category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.