Warning to pregnant women taking common medication after links to birth defects
A WARNING has been issued to pregnant women taking a common medication used for anxiety and epilepsy.
Regulators in Australia have urged medics to not prescribe pregabalin to pregnant women.
The medication has now been associated with a “slightly increased” risk of deformities in babies, affecting the nervous system, eyes, face, urinary system and genitals.
Pregabalin is also known as Lyrica and in the UK, and medics advise that you shouldn’t take it if you are trying to get pregnant, you’re already pregnant, or you are breastfeeding.
But in Australia, it’s one of the most commonly prescribed drugs, with four million prescriptions having been issued between 2021 and 2022.
When prescribed for anxiety, the drug is designed to stop your brain from releasing the chemicals that make you feel anxious.
It comes as capsules, tablets or a liquid and can only be prescribed by a doctor.
The Therapeutic Goods Administration (TGA) in Australia today said women should use effective contraception if they are taking pregabalin.
“The patient should understand the benefits and risks of pregabalin and be aware of alternatives, and be part of the decision-making process,” guidance added.
The advice was based on a study of more than 2,700 pregnant women exposed to the drug in the first trimester of pregnancy.
In April last year, medics in the UK also advised against prescribing the drugs off the back of the study.
The Nordic research found the rate of deformities was 5.6 per cent for those who use pregabalin in their first trimester.
This was compared to 4.1 per cent of those who did not use the drug or any other anti-epileptic medication.
The research suggested that the number of pregnant women taking the drug had increased over a ten year period and was mostly used in the first trimester.
However, one expert said the study is ‘low quality’ and added that the evidence points to a ‘small risk’.
Associate Professor Luke Grzeskowiak, clinical pharmacist and lead of the Reproductive and Perinatal Pharmacoepidemiology Research Group at Flinders University said: “Even if taken as true, the potential increased risk for birth defects with pregabalin would remain small, equating to an additional eight-16 cases of birth defects for every 1,000 pregnancies where it is taken in the first trimester.
What are the common side effects of pregabalin?
Common side effects usually happen in between one and 100 people and usually go away on their own, the NHS states.
They include:
- headaches
- feeling sleepy or dizzy
- diarrhoea
- mood change
- feeling sick
- blurred vision
- erectile dysfunction
- weight can
- memory issues
- swollen arms, hands, legs and feet
The NHS says that very few people have serious side effects from the medication but said you should see your GP if ay of the following occurs:
- suicidal thoughts
- thoughts of self harm
- severe dizziness – causing you to pass out
- hallucinations
- toilet issues
“Therefore, the vast majority of women taking pregabalin during pregnancy will have a healthy baby,” he told .
People usually take it in two or three separate doses – as directed by their GP.
The NHS states that if you have epilepsy, it’s likely that once your condition is under control you will continue to take pregabalin, depending on your individual situation.
“If you’re taking pregabalin for nerve pain or anxiety it’s likely that once your symptoms have gone you will continue to take it for several months to stop them coming back,” guidance states.
The Medicines and Healthcare products Regulatory Agency (MHRA), last year ruled out pregabalin’s use in pregnant women unless completely necessary.
Guidance now states the drug should not be used “unless clearly necessary and only if the benefit to the patient clearly outweighs the potential risk to the foetus”.