A new study in Neurology has shown an increased risk of birth defects in babies born to mothers taking medicines valproic acid and topiramate.
Study authors Pierre-Olivier Blotière and colleagues wanted to look at risks of birth defects to babies being exposed to 10 different epilepsy medicines in pregnancy. They were lamotrigine, pregabalin, clonazepam, valproic acid, levetiracetam, topiramate, carbamazepine, gabapentin, oxcarbazepine and phenobarbital.
The researchers used French healthcare databases of babies born between 2011 and 2015. They considered babies to have been exposed if the medicines were taken in early pregnancy (between one month before the start of the pregnancy and two months after). From a total of 1,886,825 pregnancies, 8,753 were exposed to an epilepsy medicine.
The study found that babies exposed to valproic acid had a higher risk of having eight types of birth defect, including problems with their spines (spina bifida). Topiramate was also linked to an increased risk of cleft lip.
Topiramate and valproic acid are medicines used to control seizures in epilepsy. In some women, they may be the most effective epilepsy treatment. Epilepsy Action advises that women must continue to take their epilepsy medicines as prescribed unless told otherwise by their doctor. Anyone worried about their medicines should speak to their epilepsy specialist.
Research on the effects of other medicines, including topiramate, continues to take place. Topiramate has been in the news before, when a US study also showed an increased risk in cleft lip and cleft palate in babies exposed to it in the womb.
Simon Wigglesworth, deputy chief executive at Epilepsy Action, said: “We’ve known for some time that babies born to women taking valproic acid have a high risk of being born with birth defects.
“However, as this study confirms, there are other epilepsy medicines, such as topiramate, which also cause problems. It’s vital that topiramate and other medicines which may pose a risk in pregnancy are also investigated by regulators quickly and thoroughly.
“The MHRA has told us that it is planning to carry out a review of the risks of other epilepsy medicines to the unborn child as a priority, including topiramate. We hope this will lead to clear and strong guidance – and regulatory change where this is needed – as soon as possible, to limit the number of babies exposed to these medicines.”
Sanofi have told us that their supply of Frisium (clobazam) 10mg tablets has been significantly reduced over the past 2 weeks. This is due to a temporary manufacturing disruption, coupled with changes to packaging.
Sanofi say they are taking steps to speed up the delivery of Frisium to their suppliers, and expect to have stock back to normal levels by 5 July 2019.
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a recall of some batches of 100mg Vimpat (lacosamide) tablets.
The medicines are believed to be legitimate but were taken out of the regulated medicines’ supply chain during distribution and later re-introduced. This means that the correct transport and storage conditions cannot be guaranteed during this period and, while unlikely, could impact their effectiveness.
The affected tablets are in Italian packaging with B & S Healthcare labels. The following batches are affected:
Product and pack size
Italian batch number
B&S batch number
Date of first distribution
VIMPAT 100MG TABS 1 X 56
VIMPAT 100MG TABS 1 X 56
VIMPAT 100MG TABS 1 X 56
VIMPAT 100MG TABS 1 X 56
The MHRA says if you have any of the affected tablets, you should continue taking them as normal but contact your GP practice to arrange a new prescription. Once you have a new prescription, you should return the affected batches to your pharmacist.
The findings of the report show risk of premature deaths in epilepsy is higher in low- and middle-income countries, compared to high-income countries.
Reasons given by the report include a lack of access to healthcare, leading to problems with continuing seizures and resulting injuries. Dr Tarun Dua from the Department of Mental Health and Substance Abuse at WHO called the treatment gap for epilepsy “unacceptably high”.
Stigma was also highlighted by the WHO report as a global issue in epilepsy. President of the International Bureau for Epilepsy, Prof Martin Brodie, said this is a factor “preventing people from seeking treatment”.
The report suggests that public information campaigns can help reduce stigma, and putting laws in place to protect people’s rights can decrease discrimination. To reduce treatment gaps, WHO suggests epilepsy treatment from primary care doctors, like family doctors and GPs, may improve access to healthcare and medicines in poorer areas.
Also covered in the report are strategies to reduce preventable cases of epilepsy – which represent about a quarter of all epilepsy cases. These are ones where epilepsy is caused by things like brain injuries, infections of the brain, and stroke. Screening, immunisations and better healthcare are suggested as ways to tackle this.
Dr Samuel Wiebe, president of the International League Against Epilepsy, said action is needed to introduce the necessary measures to make a difference.
The report concludes that urgent actions needed include investment in healthcare systems, more priority given to epilepsy research and improving public attitudes towards epilepsy.
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Researchers may have found a way to predict seizures in people with epilepsy using a blood test, according to a new study in the Journal of Clinical Investigation.
Scientists at research centre FutureNeuro and the Royal College of Surgeons in Ireland (RCSI) carried out the study.
Researchers Dr Marion Hogg and her colleagues collected blood samples from 16 people with hard-to-treat focal epilepsy. The participants underwent video EEG monitoring and a second blood sample was taken 24 hours after they had had a seizure. Samples were also taken from people without epilepsy for comparison.
The study found that before a seizure happened, there was a rise in the levels of a few particles in the blood samples. The researchers explained that activity in brain cells causes chemicals called tRNAs to break down into the particles seen in the blood samples.
The findings showed a spike in the levels of these particles before a seizure came on.
Lead author of the study, Dr Hogg, said: “People with epilepsy often report that one of the most difficult aspects of living with the disease is never knowing when a seizure will occur.
“The results of this study are very promising. We hope that our tRNA research will be a key first step towards developing an early warning system.”
Professor David Henshall, study author and director of FutureNeuro explained that the research paves the way for a prediction tool. He said FutureNeuro hopes to develop a device, similar to a blood sugar monitor, to predict when a seizure might occur.
A new study from the Netherlands has looked at the effectiveness of a new sleep seizure detection device. The device – Nightwatch – is a bracelet worn on the arm. It uses heart rate and movement to sense what the authors called ‘major’ seizures.
A new study in Epilepsia has suggested that children exposed to four common epilepsy medicines in the womb may have an increased risk of behavioural problems.
Study authors Yfke Huber-Mollema and her colleagues wanted to examine the effects of carbamazepine, lamotrigine, levetiracetam and valproate, used on their own.
The researchers used the Child Behaviour Checklist and Social Emotional Questionnaire filled out by the parents to test for behavioural problems in 181 children aged around 6-7 years old. Of these, 26 were exposed to valproate in the womb, 37 to carbamazepine, 88 to lamotrigine and 30 to levetiracetam.
The study compared the results of children exposed to valproate, with those of children exposed to the other 3 epilepsy medicines. It also compared the results of children exposed to lamotrigine and levetiracetam. The researchers said this is because these are the often the first-choice medicines for women of childbearing potential.
The results showed that children exposed to any of these medicines showed a higher rate of behavioural problems than children not exposed to any.
The study showed the risk was highest in the valproate group, with nearly a third of children experiencing behavioural problems (32%). These problems were also seen in over 1 in 10 children in the carbamazepine (14%), lamotrigine (16%) and levetiracetam (14%) groups.
Children exposed to valproate had a higher risk of social problems than those exposed to lamotrigine or levetiracetam. They also had a higher risk of attention problems than children exposed to levetiracetam.
When comparing levetiracetam and lamotrigine, the study authors found a difference between these medicines too. Children exposed to lamotrigine seemed to have more attention problems, but less anxious behaviour compared to those exposed to levetiracetam.
Lead author, Yfke Huber-Mollema, explained that previous studies have also found a link between exposure to epilepsy medicines and behavioural problems in children. She said exposure to valproate has been linked with these and other development and birth problems in children for a longer time.
Ms Huber-Mollema added: “The majority of children developed normally, but compared to population norms, children of mothers with epilepsy showed an increased risk of behavioural problems.
“Women who are worried about the effect of medicine use during pregnancy should contact their [epilepsy specialist]. Information provision is very important and a well-balanced choice between the risks to the mother and the unborn child should be made.
“It is important that children of mothers with epilepsy are regularly screened for developmental and behavioural problems.”
Pfizer, the makers of Epanutin (phenytoin), have told us there will be a temporary shortage of Epanutin 30mg/5ml oral suspension from the week beginning 10 June 2019. This is due to a manufacturing delay. Pfizer expect it will be out of stock until the end of July 2019.
The Department of Health & Social Care (DHSC) has sent an alert to healthcare professionals about this supply issue. They have asked GPs to make early contact with all their patients who are prescribed this medicine, to check if they have enough to last them until the end of July. If you don’t have enough supplies, you may wish to contact your GP now, rather than wait to hear from them.
While Epanutin oral suspension is out of stock, Pfizer will be importing a Canadian version of phenytoin oral suspension called Dilantin-30. The DHSC has advised GPs to switch patients who don’t have enough Epanutin oral suspension to Dilantin-30, until Epanutin is back in stock. Dilantin-30 contains the same active ingredient, and the DHSC says it can be considered equivalent to Epanutin. If you or your GP do not feel Dilantin-30 is appropriate for you, your GP should refer you to a specialist for advice.
You should not need any changes to your dose or frequency of your medicine when taking Dilantin-30. However, the Canadian patient information leaflet that comes with Dilantin-30 has different dosing information compared to the Epanutin leaflet. It’s important to follow your doctor’s instructions for taking Dilantin-30, even if these are different from the dosing information on the leaflet.
UCB, the makers of Keppra, have announced changes to the way pharmacies dispense Keppra. The changes mean that some people who usually get Keppra from their pharmacist will be given generic levetiracetam instead.
Like many medicines, levetiracetam is available in a branded version (Keppra) and also in a number of generic versions made by different manufacturers. With most medicines, pharmacists are only able to give you the branded version of a medicine if your doctor writes the brand name on the prescription. This is because the branded version usually costs more to the NHS than the generic versions. However, since 2011 UCB has had schemes allowing pharmacies to dispense Keppra even if the brand name is not written on the prescription. This was at no extra cost to the NHS.
Due to recent changes to some of the schemes UCB operates with pharmacies, some pharmacies that have previously dispensed Keppra when given a generic prescription will no longer do so.
I have Keppra written on my prescription. Will this change affect me?
This change should not affect you. If the brand name Keppra is written on your prescription, your pharmacist must continue to give you Keppra.
My prescription just says levetiracetam, but my pharmacist usually gives me Keppra. Will this change affect me?
This will depend on whether or not your pharmacy is affected by the change. Some pharmacies will continue to dispense Keppra with a generic prescription, but UCB has not revealed which ones for commercial reasons. You may wish to speak to your pharmacist to see if they are affected by the change.
What can I do if I want to stay on Keppra, but my pharmacist says they need to start giving me generic levetiracetam?
Some pharmacies will still be able to dispense Keppra, so one option is to take your prescription to a different pharmacy. As UCB has not revealed which pharmacies are affected by the change, we’re not able to say which pharmacies to try.
Alternatively, if you are concerned about taking a generic version of levetiracetam, you may wish to speak to the healthcare professional who prescribes your medicine. If you and your healthcare professional decide it’s best for you to stay on Keppra, they should write the brand name on the prescription. Your pharmacist must then give you Keppra. Epilepsy Action has more information about generic and branded medicines.