A drug used to prevent seizures and migraines has been found to double a child’s chances of developing autism if their mother takes it during pregnancy.
An urgent review has been launched of topiramate, known by the brand name Topamax, which has been prescribed for decades.
The Medicines and Healthcare products Regulatory Agency (MHRA) has begun a safety review to assess the drug’s “benefits and risks,” which is likely to increase the chances of other intellectual disorders and congenital birth defects.
A drug used to prevent seizures and migraines has been found to double a child’s chances of developing autism if their mother takes it during pregnancy. A file photo is used above
It follows warnings about another seizure medication, sodium valproate, marketed as Epilim, which has been linked to higher-than-normal rates of the same conditions.
Seven years ago, the MHRA ordered that women of childbearing age be warned about the risks of sodium valproate. However, pregnant women were prescribed it earlier this year. Experts think 20,000 babies were harmed by this.
The MHRA launched its study late last month, after Scandinavian scientists conducted an observational study of the degree of autism and intellectual disability in children whose mothers took topiramate during pregnancy.
They found that about three percent of such children had a diagnosis of autism spectrum disorder (ASD) — double the rate of 1.5 percent among those not exposed to the drug.
An urgent review has been launched of topiramate, known by the brand name Topamax, which has been prescribed for decades. A file photo is used above
About 3.5 percent of the children whose mothers took it during pregnancy were diagnosed with intellectual disability — about four times higher than the 0.8 percent in those who had not been exposed. The results were derived from reviewing patient records of 4.5 million children in five Scandinavian countries, nearly 25,000 of whom had been exposed to topiramate in utero.
In the Journal Of The American Medical Association Neurology, the scientists warned: “Our results do not suggest that topiramate is a safe alternative to sodium valproate (Epilim).”
Drug company Janssen, which makes topiramate/Topamax, said packages already contain a warning that it “should not be used during pregnancy unless the potential benefit outweighs the potential risk.”