First pills in decades to tackle morning sickness
MILLIONS of pregnant women are to get relief from morning sickness after the first drug to treat the condition in three decades was granted a licence.
Health regulators have ruled nausea pill Xonvea safe to use, meaning it will be available on the NHS.
In clinical trials the drug was found to reduce the amount of nausea by twothirds and cut the number of episodes of sickness from four a day to one.
For years doctors have been reluctant to prescribe anti-nausea drugs in pregnancy for fear of complications following the 1960s scandal over thalidomide, the drug which led to birth defects in an estimated 10,000 babies. The lack of a licensed treatment has left 690,000 women a year to suffer morning sickness, with many relying on traditional remedies such as acupuncture and ginger.
Around 80 per cent of motherstobe get some form of the illness – with two per cent diagnosed with its most extreme form hyperemesis gravidarum, from which the Duchess of Cambridge suffered.
The latter’s crippling effects have been likened to the nausea caused by chemotherapy and can cause pregnancy to be so unbearable that experts say it leads to hundreds of abortions a year.
Xonvea – which combines antihistamines with vitamin B6 in a pill taken up to four times a day – has been available in Canada since 1979 and the US since 2013.
It is available privately here at £28.50 for a box of 20 pills, but the small Canadian drug company behind the treatment was reluctant to expand to the UK because of the lasting fears over the thalidomide disaster.
A similar drug, Debendox, was briefly available in the UK in the 1970s but was withdrawn in 1983 after patients launched legal challenges over safety fears – even though the treatment was later proven to be safe.
GPs – who have been able to prescribe general anti-sickness medications – have been reluctant to do so without a specific licence saying it is safe in pregnancy.
The Medicines and Healthcare products Regulatory Agency (MHRA), which licenses drugs in the UK, has now declared Xonvea to be safe.
The decision was welcomed by experts. Professor Catherine Nelson-Piercy, consultant obstetric physician at St Thomas’ Hospital in London, said: ‘I am delighted that at last the UK has a licensed medication for the treatment of nausea and vomiting of pregnancy. This drug has now been used by 30 million around the world.
‘GPs are very cautious about prescribing drugs during pregnancy but they can now be confident they have a safe and effective drug, with a licence, and I hope they prescribe it to their patients.’
Dr Pat O’Brien, of the Royal College of Obstetricians and Gynaecologists, called it ‘a significant step forward’.
He added: ‘Xonvea should now be used as a frontline treatment for women with nausea and vomiting during pregnancy.
‘It may also be useful in treating women with hyperemesis gravidarum in combination with other anti-sickness medications.’
Caitlin Dean, chairman of the Pregnancy Sickness Support charity, said: ‘Hopefully, with the licensing of Xonvea, doctors will have the confidence to prescribe and women will have the confidence to take medication for their symptoms rather than suffer in silence.’
Clare Murphy, of the British Pregnancy Advisory Service, said: ‘We see women whose sickness is so debilitating they are left with no choice but to terminate what is often a very much wanted pregnancy.
‘With early treatment with medications including Xonvea, our hope would be that for at least some women their symptoms and sickness will not escalate to the point they need our services.’
An MHRA spokesman said: ‘Patient safety is our highest priority. As with all medicines, the safety of Xonvea will be carefully monitored and action taken as needed to protect public health.’
‘A significant step forward’