A drug used to prevent epileptic seizures and migraine has been found to double the chances of a child developing autism if their mother takes it while pregnant.
An urgent review has been launched into 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 ‘benefits and risks’ of the drug, which is likely to raise the odds of other intellectual impairments, as well as congenital birth defects.
It follows warnings about another epilepsy drug, 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 child-bearing age should be warned about sodium valproate’s risks. However, pregnant women were still being prescribed it earlier this year. Experts believe 20,000 babies have been harmed as a result.
The MHRA launched its investigation late last month, after Scandinavian scientists conducted an observational study looking at rates of autism and intellectual disability in children whose mothers took topiramate while pregnant.
They found that about three per cent of such children had an autism spectrum disorder (ASD) diagnosis – double the 1.5 per cent rate among those not exposed to the drug.
Some 3.5 per cent of children whose mothers took it while pregnant were diagnosed with an intellectual disability – about four times higher than the rate of 0.8 per cent among those unexposed. The results were derived from looking at patient records from 4.5 million children across five Nordic countries, of which almost 25,000 had been exposed to topiramate in the womb
Writing 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).’
Drugs firm Janssen, which makes topiramate / Topamax, said packs already contained a warning that it ‘should not be used during pregnancy unless the potential benefit outweighs the potential risk’.
Source : dailymail.co.uk MARTYN HALLE and STEPHEN ADAMS FOR THE MAIL ON SUNDAY