Australia’s medicines regulator is warning pregnant women to avoid taking the drug pregabalin after a study linked the medication to a slightly increased risk of major congenital malformations in their unborn babies.
The Therapeutic Goods Administration (TGA) issued a safety update urging doctors not to prescribe pregabalin – most commonly known by the brand name Lyrica – to pregnant women unless the benefits to the mother clearly outweigh the potential risks to their unborn child.
The TGA has advised pregnant women and women trying to conceive not to take the drug, Lyrica.Credit:iStock
The drug’s primary use is to treat epilepsy but is widely prescribed for chronic pain, and is one of Australia’s most commonly prescribed drugs, with almost 4 million prescriptions issued in 2021-2022.
“Women should use effective contraception if they are taking pregabalin,” the TGA’s safety update said.
“The patient should understand the benefits and risks of pregabalin and be aware of alternatives, and be part of the decision-making process,” it read.
The TGA said its updated advice was based on a study of more than 2700 pregnant women exposed to pregabalin in the first trimester, which has not been peer-reviewed.
In April last year, the UK regulator advised doctors against prescribing the drug during pregnancy on the back of the study.
The Nordic study analysed the data from national registries in Denmark, Finland, Norway and Sweden and compared babies born to mothers who took pregabalin, two other medications (lamotrigine or duloxetine) or none of these medications.
It found a slightly higher prevalence of major congenital malformations among the babies of mothers who had taken pregabalin compared with babies of the other mothers.
Roughly six babies in 100 born to women who took pregabalin during pregnancy had physical birth abnormalities compared with four in 100 babies born to women who were not taking pregabalin or other epilepsy medications.
The TGA this month changed the pregnancy category for pregabalin to D, which is reserved for drugs that have caused, or are suspected to have caused, an increased incidence of fetal malformations or irreversible damage.
Associate Professor Luke Grzeskowiak, clinical pharmacist and lead of the Reproductive and Perinatal Pharmacoepidemiology Research Group at Flinders University said the TGA’s decision did not appear entirely commensurate with the available evidence.
“The safety alert appears to be based solely on the findings of one study, which has not been subject to traditional peer review. At best, this single study provides only low-quality evidence of a possible small increased risk for birth defects,” Grzeskowiak 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 1000 pregnancies where it is taken in the first trimester. Therefore, the vast majority of women taking pregabalin during pregnancy will have a healthy baby,” he said.
He said there were concerns that the update could create unnecessary confusion and concern regarding the appropriateness of pregabalin use in pregnancy and lead to misinformed decision making when balancing potential risks and benefits.
“For those whose illness is well controlled with pregabalin, staying on it may still remain the best option,” he said.
An investigation by the Herald and The Age in 2018 found pregabalin – marketed as safe and non-addictive – was highly addictive, dangerous when taken with other medications and carried a risk of nasty side effects, including suicidal thoughts.
Dr Benjamin Bopp, president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said obstetricians would follow the TGA’s guidance.
“Though if you’ve been on [pregabalin] all through your pregnancy, as per your specialist advice, and you’re 30 weeks gestation when this new safety update has just come out and it is not safe for you to cease, then you would just stay on it because you’re already through that organogenic period – the period where the major malformation occur,” he said.
“If you’re taking [pregabalin] and you’re planning a pregnancy, then I imagine [the prescribing doctor] would look at substituting onto something else.
“The standard advice for medications in pregnancy is that you should be on as few medications as you can when you’re pregnant and if you absolutely have to be on something you should be on the lowest dose that you need. Anybody who is taking this medication should seek advice from their prescriber,” Bopp said.
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