The epilepsy and chronic pain drug has been linked to major congenital malformations.
Doctors should avoid prescribing pregabalin to pregnant women after the medication has been tied to major congenital malformations in babies, the TGA has advised.
The regulator advises women of child-bearing age who take pregabalin (Lyrica, Viatris) for neuropathic pain or as an adjunctive therapy for partial seizures to use effective contraception.
And doctors should only prescribe the medication in pregnant women when the benefit to the patient clearly outweigh the potential risk to the fetus.
“The patient should understand the benefits and risks of pregabalin and be aware of alternatives, and be part of the decision-making process.”
The regulator moved pregabalin from category B3 to D after the release of data showing a higher prevalence of major congenital malformation in babies exposed to pregabalin in utero compared to babies who were not exposed to the drug.
The Nordic population study of 2700 pregnant women found that 5.9% of babies exposed to pregabalin during the first trimester had major congenital malformations, compared to 4.1% of babies exposed to lamotrigine or duloxetine, or to no drug.
“Health professionals should inform women using pregabalin about the potential risks to an unborn baby and advise them to use effective contraception during treatment,” the TGA said in a statement.
Manufacturer Viatris updated its product information to include the new research findings along with a warning for women of childbearing age.
“Lyrica use in the first trimester of pregnancy may cause major birth defects in the unborn child,” the product information now says.
“The analyses on specific malformations showed higher risks for malformations of the nervous system, the eye, orofacial clefts, urinary malformations and genital malformations, but numbers were small and estimates imprecise.
“Lyrica should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the fetus).”
It also noted the safety of pregabalin in infants was unknown, so breastfeeding was not recommended in women taking Lyrica.
“A decision must be made whether to discontinue breastfeeding or to discontinue Lyrica therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.”
According to the product information, the risk of major congenital malformations was 14% higher among babies exposed to the drug in utero compared to the unexposed population, 29% higher than those exposed to lamotrigine and 39% higher than those exposed to duloxetine.
