Warning over epilepsy prescription drug taken by thousands

Health officials have issued an urgent warning over a daily medication taken by tens of thousands of patients with epilepsy.  

UK medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) stuck an alert on batches of Topiramate Zydus 20mg/ml oral solution. 

It is feared the prescription drug was packaged incorrectly as instructions on how to take the medication correctly are missing.  

But the MHRA, which published the alert, said the batches with the ‘defect’ should still be dispensed and prescribed by health professionals. 

Instead, patients must be advised to shake the bottle well prior to opening it and before each use. 

The alert only impacts three batches of the drug, manufactured by Zydus Pharmaceuticals UK.

Batch numbers TPR24001 and TPR24002, both 280ml have an expiry date of June 2026. Batch number TPR24003, meanwhile, which is 150ml, has an expiry date of September 2026. 

The liquid oral medication is normally started on a low dose before it is slowly increased. 

Health officials urged patients, however, not to stop taking the drug without medical advice. 

‘Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before,’ the MHRA said.   

The medicine ‘should not cause harm if taken without shaking’, the health watchdog added. 

But any patients who experience an adverse reaction or have questions about the recall should seek medical attention. 

Adverse reactions should also be reported via the MHRA’s Yellow Card scheme. 

The scheme, set up in the 1960s, allows doctors, pharmacists and patients themselves to report adverse reactions believed to be caused by prescription and over-the-counter drugs, implants and alternative medicines. 

This can lead to them being reviewed, having warnings added to the label or even being taken off the market.

Around one in 100 people, or 630,000 in the UK, have epilepsy.

It’s characterised by bursts of uncontrolled electrical activity in the brain, which prevents nerve cells from signalling to each other properly—triggering seizures that can last for several minutes.

The main treatment is anti-epileptic drugs, which make brain cells less ‘excitable’ and less likely to misfire.

In more severe cases, surgery may be needed—to remove a small part of the brain that’s causing the attack, or to implant a tiny device that interrupts the chaotic signals between nerve cells.