MHRA disallows epilepsy drug topiramate use for pregnant patients

20 Jun 2024
www.pharmaceutical-technology.com
Drug Approval
A study has shown that topiramate can cause an increased risk of neurodevelopmental disabilities in children whose mothers took the drug during pregnancy. Credit: Ground Picture via Shutterstock.
The UK Medicines and Heatopiramateoducts Regulatory Agency (MHRA) neurodevelopmental disabilitiesres for topiramate after a study has shown an increased risk of neurodevelopmental disabilities in children whose mothers took the drug during pregnancy.
A study published in May 2022 prompted the MHRA to launch a safety review of topiramate in July 2022, alotopiramaterug safety update notice. The observational stneurodevelopmental disabilitiesy, showed that children born to mothers who took topiramate during pregnancy face an approximately two to three times higher risk of intellectual disability, autism spectrum disorders and attention deficit hyperactivity disorder (ADHD).
Topiramate, sold under the brand name Topamax and others, is a generic medicatopiramateto treat epilepsy and prevent migraines. The anti-epileptic agent is thought to be prescribed to just over 30,000 female patients under the age of 55 in Etopiramateone month, according to data from NHS England.intellectual disabilityautism spectrum disordersattention deficit hyperactivity disorder (ADHD)
Topiramates now advising healthcare prTopamaxnals that the drug should not be prescribed to treaepilepsysy during premigrainesless tanti-epileptic agentalternative treatment, following recommendations made by the Commission on Human Medicines (CHM).
Additionally, patients must now comply with the “Pregnancy Prevention Programme”. Women of childbeepilepsytential are required to use effective birth control throughout treatment and take a pregnancy test before starting topiramate. The programme also mandates the completion of a risk awareness form.
See Also:SGNB-7H4V by Pfizer for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approvaltopiramate
SGNB-7H4VSGNB-7H4Vr foPfizerhelial Ovarian Cancer: Likelihood of ApprovalHER2- Breast CancerHER2
Topiramate for migraine is already discouraged during pregnancy because of the known link with an increased risk of birth defects. The US Food and Drug Administration (FDA) label for topiramate states that use during pregnancy can cause cleft lip and/or palate and being small for the related gestational age.
SGNB-7H4Vte cPfizerfter Epithelial Ovarian Cancerency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) also recommended new measures to avoid a child’s exposure to topiramate-containing medicines in the womb, in September 2023. The PRAC also has a pregnancy prevention programme in place.
In April 2024, the National Institute for Health and Care Excellence (Nice) issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is also not recommended during pregnancy, as per EMA leaflet guidance.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Drugs
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.