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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - June 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2024 (PDF).

This issue advises clinicians about the introduction of new safety measures, including a Pregnancy Prevention Programme for topiramate. This treatment is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. Maternal use of topiramate during pregnancy is associated with significant harm to the unborn child including a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder. It is recommended that topiramate is not be used in pregnancy for migraine and should only be used in epilepsy if there is no other suitable treatment. The Pregnancy Prevention Programme aims to ensure that all women of childbearing potential are using highly effective contraception, have a pregnancy test to exclude pregnancy before starting topiramate and are aware of the risks from use of topiramate.

This issue also warns clinicians of a potentially fatal interaction between warfarin and tramadol. This warning is being made after the MHRA received a Coroner’s report following the death of a patient. Concurrent use of tramadol and warfarin can increase the risk of bleeding through an increased INR. Ideally this combination should be avoided. Patients who are prescribed this combination should be advised to seek medical treatment and have an urgent INR test should they experience:

  • prolonged nose bleeds (more than 10 minutes)
  • blood in vomit, sputum (phlegm), stool or urine
  • severe or unexplained bruising
  • severe bleeding gums
  • unusual headaches (headaches with blurred vision, slurred speech, loss of movement, feeling or being sick, fits, loss of consciousness, dizziness)
  • women who experience heavy or increased bleeding during their menstrual period or any other heavy vaginal bleeding

Lastly, this issue contains a summary of letters to healthcare professionals in May. These generally related to supply issues and recalls.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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