COVID-19 Antivirals: Reporting to the UK COVID-19 Antiviral Pregnancy Register

Advice for healthcare professionals:

  • the UK COVID-19 Antivirals Pregnancy Registry is operated by the MHRA in conjunction with the UK Teratology Information Service (UKTIS) to collect information on exposures to COVID-19 antivirals during pregnancy and enable follow-up of any reported pregnancy; the registry also collects information on the outcomes of pregnancies where conception occurred during or shortly after the father’s exposure to antiviral treatment
  • to report to the registry, telephone: 0344 892 0909 (reachable from 9:00 a.m. to 5:00 p.m., Monday to Friday, excluding public holidays) – for more information see the UKTIS website
  • healthcare professionals in England, Scotland and Wales (as well as patients and their partners) may report exposure to a COVID-19 antiviral during pregnancy or at the time of conception, or partners on COVID antiviral -19 at design time
  • in Northern Ireland, healthcare professionals cannot currently report on behalf of a pregnant woman or her partner, but should encourage them to report themselves using the same contact details
  • since exposure can occur very early in pregnancy before the pregnancy is recognized, we ask healthcare professionals to report (or encourage patients to self-report), even if some time s elapsed since the end of their COVID-19 antiviral treatment.

COVID-19 antiviral drugs

The oral antiviral drugs molnupiravir (Lagevrio▼) and the combination of PF-07321332 (nirmatrelvir) plus ritonavir (Paxlovid▼) have been authorized for use in people aged 18 and over who have mild to moderate COVID-19 and at least one risk factor for the development of a serious illness. These risk factors include obesity, advanced age (over 60), diabetes mellitus, or heart disease. See Summary of Product Characteristics for Lagevrio▼ and Paxlovid▼.

The intravenous antiviral remdesivir (Veklury ▼) is licensed for the treatment of COVID-19 in adults and adolescents (aged 12 to 18 years and weighing at least 40 kg) with pneumonia requiring oxygen supplementation (low or high-flow or other non-invasive ventilation at the start of treatment). It is also licensed for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

Because COVID-19 antivirals are new drugs, their safety in pregnancy is not yet understood. Studies with molnupiravir in animals have shown signs of reproductive toxicity (harmful effects in an unborn animal); the implications of these data for safety in human pregnancy are not yet known. Animal studies have shown no harm to PF-07321332 or remdesivir, however, human pregnancy data are lacking and a cautious approach to their use is advocated.

Information on effective and safe use, including advice on contraception, is available in the product information for:

Information for patients on COVID-19 antivirals is also available from other clinical resources or resources such as UKTIS Bumps and the NHS website.

Information for patients on COVID-19 antivirals is also available from other clinical resources or resources such as UKTIS Bumps and the NHS website.

The UK COVID-19 Antiviral Pregnancy Registry

The UK COVID-19 Antivirals Pregnancy Registry aims to collect information on exposures to COVID-19 antivirals during or shortly before pregnancy. The registry also collects information on the outcomes of pregnancies where conception occurred during or shortly after paternal exposure to COVID-19 antiviral treatment. It is hoped that the information collected by the registry will enable the MHRA, UKTIS and healthcare providers to assess the outcomes of exposures to COVID-19 antivirals during and around pregnancy.

The reporting route for relevant exposures in the register is handled by the UK Teratology Information Service (UKTIS), on behalf of the MHRA. UKTIS is part of the Newcastle National Poisons Information Service and regularly collects information on medicines in pregnancy to better understand the effects medicines can have on unborn babies.

How to report a pregnancy exposed to a new COVID-19 antiviral

To report an exposed pregnancy to UKTIS, telephone: 0344 892 0909 (available 9am to 5pm, Monday to Friday, excluding public holidays).

Patients in the UK (England, Scotland, Wales and Northern Ireland) can report directly to the registry if they used a COVID-19 antiviral medicine when they were pregnant, shortly before pregnancy or shortly before pregnancy. close to when their partner has conceived.

Healthcare professionals in England, Scotland and Wales can report exposures on behalf of pregnant patients or their partners.

In Northern Ireland, healthcare professionals cannot currently report on behalf of a patient, but should encourage pregnant patients or their partners to report to the registry using the same information.

Further information is available on the UKTIS register website. The website includes details on privacy and tracking.

Because exposures can occur very early in pregnancy before pregnancy is recognized, we ask healthcare professionals to report (or encourage patients to self-report), even if some time s elapsed since the end of their COVID-19 antiviral treatment.

Report suspected adverse drug reactions via a yellow card

All other suspected adverse reactions should be reported to the Yellow Card system.

Report suspected side effects from incidents related to medicines, vaccines, medical devices and test kits used in the testing and treatment of coronavirus (COVID-19) using the dedicated coronavirus yellow card reporting site or the Yellow Card app. Check the MHRA website for the latest information on COVID-19 medicines and vaccines.

Article citation: Drug Safety Update Volume 15, Issue 7: February 2022: 1.

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