Pregnancy: Drugs

Prescribers are expected to work with patients to make decisions about their care and treatment as part of shared decision-making, and this should include discussing risks, benefits, and possible consequences of different options. Where applicable, the risk of teratogenic effects should be made clear as part of these discussions.

The Medicines and Healthcare products Regulatory Agency (MHRA), acting on behalf of my Rt Hon. Friend, the Secretary of State for Health and Social Care, is responsible for the regulation of all medicines and medical devices in the United Kingdom, by ensuring they work and are acceptably safe.

Pharmaceutical companies are required to test the medicines used in their products for teratogenicity, and the MHRA requires that information on the teratogenic properties of medicines, and the actions required to minimise risk, are included in the Summary of Product Characteristics (SmPC) for healthcare professionals, as well as the Patient Information Leaflets (PIL) of licenced products.

Where necessary, the MHRA will undertake additional work to raise awareness, for example in the case of valproate, a medicine with teratogenic properties. The risks with valproate when taken during pregnancy have been communicated by using SmPC and PIL updates. In addition, the magnitude and type of risks associated with valproate use in pregnancy have also been communicated in articles in the MHRA’s bulletin, Drug Safety Update, and letters through the NHS Central Alerting System, supported by messages from professional bodies reinforced through changes to clinical guidelines and improved alerts in general practitioner prescribing systems.