New ban on epilepsy drug in pregnancy

An epilepsy drug that can damage unborn babies must no longer be prescribed to girls and women of childbearing age in the UK unless they sign a form to say that they understand the risks.

Drug regulator the MHRA says the new measures it’s introducing will keep future generations of children safe.

Those already on valproate medication should see their GP to have their treatment reviewed.

No woman or girl should stop taking it without medical advice though.

It is thought about 20,000 children in the UK have been left with disabilities caused by valproate since the drug was introduced in the 1970s.

Affected families have called for a public inquiry and compensation.

Epilepsy charities say one in five women on sodium valproate are unaware that taking it during pregnancy can harm the development and physical health of an unborn baby.

And more than one in four have not been given information about risks for their unborn child.

The MHRA has changed the licence for valproate, which means any doctor prescribing it will have to ensure female patients are put on a Pregnancy Prevention Programme, which means:

  • The patient can see her doctor every year to discuss the risks of this drug to an unborn baby
  • She signs an acknowledgement form at least every year
  • She is told about the importance of using contraception throughout treatment and having a pregnancy test if she thinks she could be pregnant

    If valproate is taken during pregnancy, up to four in 10 babies are at risk of developmental disorders, and approximately one in 10 are at risk of birth defects.

    Dr June Raine, from the MHRA, said: “Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor.

    “I would like to particularly thank the families involved in the Valproate Stakeholder Network who have shared their experiences and expertise with us. Their support will help keep future generations of children safe.”

    Simon Wigglesworth, deputy chief executive of Epilepsy Action, said: “We know there are still far too many women who haven’t been made aware of the potential risks of taking sodium valproate in pregnancy.

    “It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines.”

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Dementia ‘linked’ to common over-the-counter drugs

A study has linked commonly used medicines, including over-the-counter treatments for conditions such as insomnia and hay-fever, to dementia.

All of the types of medication in question are drugs that have an “anticholinergic” effect.

Experts say people should not panic or stop taking their medicines.

In the US study in the journal JAMA Internal Medicine, higher doses and prolonged use were linked to higher dementia risk in elderly people.

The researchers only looked at older people and found the increased risk appeared when people took drugs every day for three years or more.

Side-effects

All medicines can have side-effects and anticholinergic-type drugs that block a neurotransmitter called acetylcholine are no exception.

Patient information leaflets accompanying such drugs warn of the possibility of reduced attention span and memory problems as well as a dry mouth.

But researchers say people should also be aware that they may be linked to a higher risk of developing dementia.

Dr Shelly Gray and colleagues from the University of Washington followed the health of 3,434 people aged 65 and older who had no signs of dementia at the start of the study.

They looked at medical and pharmacy records to determine how many of the people had been given a drug with an anticholinergic effect, at what dose and how often and compared this data with subsequent dementia diagnoses over the next decade.


Drugs in the study

The US study does not name specific brands, but does outline the types of treatments investigated, which include:

  • Tricyclic antidepressants for treating depression
  • Antihistamines used to treat hay-fever and allergies
  • Antimuscarinics for treating urinary incontinence

    Most of the drugs were given on prescription, rather than bought at the pharmacy over-the-counter.


    The most commonly used anticholinergic-type drugs were medicines for treating depression, antihistamines for allergies such as hay-fever or to aid sleep/promote drowsiness, and drugs to treat urinary incontinence. Nearly a fifth were drugs that had been bought over the counter.

    Over the course of the study, 797 of the participants developed dementia.

    ‘Not causal’

    The study estimated that people taking at least 10 mg/day of doxepin (antidepressant), four mg/day of diphenhydramine (a sleep aid), or five mg/day of oxybutynin (a urinary incontinence drug) for more than three years would be at greater risk of developing dementia.

    The researchers say doctors and pharmacists might want to take a precautionary approach and offer different treatments instead. And when there is no alternative, they could give the lowest dose for the shortest time possible.

    Dr Gray says some of the study participants have agreed to have an autopsy after their death.

    “We will look at the brain pathology and see if we can find a biological mechanism that might explain our results.”

    Dr Simon Ridley, head of research at Alzheimer’s Research UK, said the study was interesting but not definitive – there was, he said, no evidence that these drugs cause dementia.

    Dr Doug Brown, from the UK’s Alzheimer’s Society, said: “There have been concerns that regular use by older people of certain medications with anticholinergic effects, such as sleep aids and hay-fever treatments, can increase the risk of dementia in certain circumstances, which this study supports.

    “However, it is still unclear whether this is the case and if so, whether the effects seen are a result of long-term use or several episodes of short-term use. More robust research is needed to understand what the potential dangers are, and if some drugs are more likely to have this effect than others.

    “We would encourage doctors and pharmacists to be aware of this potential link and would advise anyone concerned about this to speak to their GP before stopping any medication.”

    He said the charity was funding more research in this area to better understand any connections between these and other drugs on the development of dementia.

    The Medicines and Healthcare Products Regulatory Agency, which monitors the safety of medicines in clinical use in the UK, said it would review any new evidence.

    Drug company Johnson & Johnson Ltd said many hay-fever products sold in the UK now contain newer, second generation antihistamines – not the type looked at in the study.

    Matthew Speers, who represents the UK trade association for manufacturers of over-the-counter drugs, said: “Over-the-counter allergy and sleeping aid products are not intended to be used continuously and people are advised to talk to their pharmacist or doctor if they need to use these products long-term.

    “There are a range of allergy products on the market which contain a number of different ingredients, many of which were not considered in this study.”