Pizotifen

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Date: September 2024, Version 4.0

Quick read

Pizotifen is avoided during pregnancy, if possible, as there is not enough information to confirm that it is safe for the baby.

What is it?

Pizotifen is a sedating (drowsy) antihistamine prescribed to prevent specific types of severe recurrent headache (vascular headaches, migraines and cluster headaches).

Benefits

What are the benefits of taking pizotifen in pregnancy?

Pizotifen can prevent severe recurrent headaches which can be disabling. Pizotifen treatment might therefore improve a woman’s wellbeing and quality of life.

Risks

Are there any risks of taking pizotifen during pregnancy?

Fewer than 50 women taking pizotifen in early pregnancy have been studied. No concerns have been raised, but more research is required to confirm it is safe for pregnant women to use. Pizotifen is not recommended during pregnancy unless there is no other option to prevent headaches that seriously affect quality of life.

Alternatives

Are there any alternatives to taking pizotifen?

Possibly. Other medicines can be used to prevent or treat severe headaches; however, in rare cases, pizotifen may be the only medicine that works well, or a woman and her doctor may decide it is best to stay on it rather than try something new and risk a relapse.

Ideally, women planning a pregnancy should speak to their GP or specialist to determine whether pizotifen is still the best option for them. Similarly, women who have an unplanned pregnancy while taking pizotifen should be reviewed at the earliest opportunity by their GP or specialist.

No treatment

What if I prefer not to take medicines to prevent or treat severe headaches?

Untreated severe headaches generally do not pose a direct physical health risk you or your baby, but can greatly affect your quality of life, your ability to carry out activities of daily living, and may affect your mental health. There are a number of medicines to treat headache that can be safely used during pregnancy. Your doctor will be happy to talk to you about the benefits and possible risks.

Will my baby need extra monitoring?

All pregnant women in the UK should be offered a very detailed anomaly scan at around 20 weeks of pregnancy as part of their routine antenatal care. No extra monitoring for major birth defects is required following pizotifen use in pregnancy. 

Are there any risks to my baby if the father has taken pizotifen?

We do not expect any increased risk to your baby if the father takes pizotifen.

Who can I talk to if I have questions?

If you have any questions about the information in this leaflet, please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org.

How can I help to improve drug safety information for pregnant women in the future?

Our online reporting system (MyBump Portal) allows women who are currently pregnant to create a secure record of their pregnancy, collected through a series of questionnaires. You will be asked to enter information about your health, whether or not you take any medicines, your pregnancy outcome and your child's development. You can update your details at any time during pregnancy or afterwards. This information will help us better understand how medicines affect the health of pregnant women and their babies. Please visit the MyBump Portal to register.

General information
Sadly, miscarriage and birth defects can occur in any pregnancy.

Miscarriage occurs in about 1 in every 5 pregnancies, and 1 in every 40 babies are born with a birth defect. This is called the ‘background risk’ and happens whether medication is taken or not.

Most medicines cross the placenta and reach the baby. For many medications this is not a problem. However, some medicines can affect a baby’s growth and development.

If you take regular medication and are planning to conceive, you should discuss whether your medicine is safe to continue with your doctor/health care team before becoming pregnant. If you have an unplanned pregnancy while taking a medicine, you should tell your doctor as soon as possible.

If a new medicine is suggested for you during pregnancy, please make sure that the person prescribing it knows that you are pregnant. If you have any concerns about a medicine, you can check with your doctor, midwife or pharmacist.

Our Bumps information leaflets provide information about the effects of medicines in pregnancy so that you can decide, together with your healthcare provider, what is best for you and your baby.

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