ADR that result in revision of patient information
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| Australia: Avoid prescribing pregabalin in pregnancy if possible |
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Therapeutic Goods Administration (TGA) announces that the Product Information (PI) for pregabalin has been updated to strengthen the warning to avoid prescribing in pregnancy. The change was made after a study showed an increased risk of major congenital malformations associated with the medicine.
Women should use effective contraception if they are taking pregabalin and treatment should not be prescribed to pregnant women unless the benefits to the mother clearly outweigh the potential risks to their unborn child.
The strengthened warning follows recent data from a Nordic observational study of more than 2,700 pregnant women exposed to pregabalin in the first trimester. The study used data from national registries in Denmark, Finland, Norway and Sweden and compared babies born to mothers who took pregabalin, lamotrigine, duloxetine or none of these medicines. The study found a higher prevalence of major congenital malformations among babies exposed to pregabalin in utero compared to babies who were not exposed (5.9% vs. 4.1%).
In response to these findings, the pregnancy category for pregabalin has been changed from B3 to D in Australia. The PI for the innovator pregabalin product, Lyrica, has been updated to include additional warnings and a summary of the results from the Nordic study. Generic sponsors of pregabalin will update their PIs to align with this safety information.
Health professionals should inform women using pregabalin about the potential risks to an unborn baby and advise them to use effective contraception during treatment. Pregabalin should only be prescribed during pregnancy if the benefit to the patient clearly outweighs 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.
PI changes for Lyrica:
- The pregnancy category for pregabalin has been changed from B3 to D.
- Section 4.4 now includes a special warning for women of childbearing age which states:
‘Lyrica use in the first trimester of pregnancy may cause major birth defects in the unborn child. Pregabalin should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the fetus. Women of childbearing potential have to use effective contraception during treatment.’
- Section 4.6 now includes a summary of the Nordic observational study:
‘Data from a Nordic observational study of more than 2,700 pregnancies exposed to pregabalin in the first trimester showed a higher prevalence of major congenital malformations (MCM) among the paediatric population (live or stillborn) exposed to pregabalin compared to the unexposed population (5.9% vs. 4.1%). The risk of MCM among the paediatric population exposed to pregabalin in the first trimester was slightly higher compared to unexposed population (adjusted prevalence ratio and 95% confidence interval: 1.14 (0.96-1.35)), and compared to population exposed to lamotrigine (1.29 (1.01–1.65)) or to duloxetine (1.39 (1.07–1.82)). 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.’
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/avoid-prescribing-pregabalin-pregnancy-if-possible
In Hong Kong, there are 51 registered pharmaceutical products containing pregabalin. All products are prescription-only medicines. So far, the Department of Health (DH) has received 19 cases of adverse drug reaction related to pregabalin, but these cases were not related to congenital malformations. Related news was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 20 Apr 2022. Letters to inform local healthcare professionals were issued by the DH on the same day. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Feb 8, 2023
Issued at HKT 15:00
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