Taking a medication to treat migraines and epileptic seizures when pregnant has been proven to double the risk of a kid developing autism.
The prescription drug topiramate, also known by its brand name Topamax, has undergone an urgent review.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has started a safety study to evaluate the “benefits and hazards” of the medication, which may increase the chance of congenital birth abnormalities and other intellectual disabilities.
It comes after cautions on sodium valproate, sold under the brand name Epilim, another epilepsy medication that has been connected to higher-than-average incidence of the same problems.
The MHRA mandated seven years ago that women of childbearing age be informed of the dangers of sodium valproate.
However, early this year, it was still being recommended to expectant mothers.
According to experts, 20,000 newborns have suffered as a consequence.
After Scandinavian researchers completed an observational study examining the prevalence of autism and intellectual impairment in children whose mothers used topiramate while pregnant, the MHRA opened its inquiry late last month.
They discovered that roughly 3% of these kids were diagnosed with autism spectrum disorder (ASD), which is twice the 1.5% prevalence among kids who weren’t exposed to the medicine.
The risk of intellectual impairment among children whose moms used it while pregnant was around 3.5%; this is almost four times greater than the rate of 0.8% among those not exposed.
The findings came from an analysis of the medical records of 4.5 million kids from five Nordic nations, over 25,000 of whom had been exposed to topiramate while still in the womb.
The researchers issued the following warning in their article published in the Journal Of The American Medical Association Neurology: “Our data do not imply that topiramate is a safe alternative to sodium valproate (Epilim).”
Topiramate/Topamax is manufactured by the pharmaceutical company Janssen, which claimed that warnings stating that it “should not be taken during pregnancy unless the potential benefit justifies the possible risk” were already included on packs.