Benzodiazepines
Eric Ollerenshaw: To ask the Secretary of State for Health what warnings his Department has issued on possible teratogenic effects of the use of benzodiazepines; when such warnings were issued; and on what scientific evidence they were based. [90539]
Mr Simon Burns: There are limited data relating to the safety of use of benzodiazepines in pregnancy and the implications for the unborn child. Clinical trials or
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studies are not routinely conducted in pregnant women. Consequently, the data available in relation to safety in pregnancy mainly comes from animal studies, spontaneous case reports and practical experience with the medicine over time. Evidence from these sources is carefully evaluated and the relevant information is reflected in the product information.
In 1980, guidance on the use of benzodiazepines was published by the Committee on the Review of Medicines, this included use during pregnancy. In September 1997, the medicines regulatory authority and its advisory committee published further information in the bulletin Current Problems in Pharmacovigilance. This guidance strengthened the guidance previously provided that benzodiazepines are associated with a risk of neonatal withdrawal symptoms if benzodiazepines are used during the latter stages of pregnancy. In addition, it advised that high doses administered during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression. It advised that benzodiazepines can also pass into the breast milk of mothers in sufficient doses to cause side effects in the babies and therefore should be avoided, if possible, during breast-feeding.
Benzodiazepines are therefore not recommended for use during pregnancy unless there is clear clinical need for which the benefits to the mother, such as seizure control, are considered to outweigh the risk to the foetus. Any woman of childbearing potential, should be advised to speak with her doctor about stopping the product if she intends to become pregnant or suspects that she is pregnant.
Information regarding use during pregnancy, is provided in the product information for each product. Guidance is also provided in the British National Formulary which is provided free to all prescribes in the NHS.
Taken from Parliament’s website: http://www.publications.parliament.uk/pa/cm201212/cmhansrd/
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