EMA Updates Topiramate Guidance : The European Medicines Agency’s safety group issued new rules for administering Topiramate to pregnant women. Steps implemented to prevent infants from accessing topiramate medications. This is due to concerns that the drug may harm the child’s brain growth during pregnancy. Taking Topiramate while pregnant can cause severe birth problems. Following a report in JAMA Neurology, the UK’s MHRA started investigating topiramate safety in July 2022. This study suggests that taking Topiramate during pregnancy may increase the risk of autism or developmental issues in children.
A study was done by experts led by Marte-Helene Bjrk and her team. When Topiramate is used alone, it increases the likelihood of a child with autism or developmental issues having a mother who took the drug during pregnancy. The risk is 2-4 times higher. In 2019, Neurology published a study on concerns about using Topiramate during pregnancy. Scientists like Pierre-Olivier Blotière found that topiramate use in mothers increases the risk of birth defects in their children. With this risk, there was a higher chance of a split lip.
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Epilepsy Action advises women to continue taking their prescribed epilepsy drugs, unless instructed otherwise by their doctor. If concerned about medication during pregnancy, talk to an epilepsy expert. Epilepsy Action seeks MHRA update on topiramate safety review. They want to know if it’s risky for pregnant women.
EMA’s safety group proposed new regulations. This shows their effort to ensure the safety and health of pregnant women and their babies when taking medicine. Steps were taken to reduce problems when pregnant women take Topiramate. They are concerned about the potential impact on a child’s brain growth if the mother uses the drug. The choice highlights the importance of continuous learning and vigilance of potential drug risks, especially during pregnancy. This ensures the health and safety of both the mother and baby. Doctors and rule-makers must be cautious and prioritize people’s safety. This is crucial for pregnant women and their kids, who are more susceptible to medicine-related illnesses. The aim is to ensure good medical care and minimize risks for pregnant women.
Our Reader’s Queries
What is the new indication for topiramate?
Topiramate is a versatile medication that can be used to treat a variety of conditions. It is particularly effective as a monotherapy for partial onset or primary generalized tonic-clonic seizures in patients aged 2 years and above. Additionally, it can be used as an adjunctive therapy for partial onset seizures or primary generalized tonic-clonic seizures in both adult and pediatric patients over the age of 2. With its broad range of applications, topiramate is a valuable tool in the treatment of neurological disorders.
What are the rules for topiramate doses?
For adults, the initial dose of this medication is typically 25 to 50 milligrams (mg) taken once daily. Your doctor may adjust the dosage as necessary, but it usually does not exceed 400 mg per day. Children aged 2 and above should consult their doctor to determine the appropriate dosage based on their body weight.
Is topiramate legal in Europe?
The PRAC recommendations regarding medicines containing topiramate have been forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh). This body represents EU Member States, as well as Iceland, Liechtenstein, and Norway, since all topiramate-containing medicines are authorised nationally.
What is the adjustment period for Topamax?
Migraine prevention with Topamax typically involves a gradual increase in dosage over a 4-week period. Your physician will begin with lower doses and gradually increase them to ensure optimal results.