Drugs Given To Babies. Nine out of 10 medicines used on newborn babies have not been tested properly, an alarming report has revealed. It also warns that around half of all prescription and over-the-counter drugs given to under-18s have not being put through suitable trials.
The report by a House of Lords committee calls for ‘overwhelming and urgent’ action to protect Britain’s 13 million children amid fears that the untested drugs could be causing harm.
It said that ‘too many’ young patients were routinely being given adult drugs in lower doses. Pharmaceutical companies are reluctant to carry out testing on children because of the cost. This has left doctors with no alternative but to estimate correct doses based on a child’s height, weight and symptoms.
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Baroness Walliswood, chairman of the Lords committee, said: “So many of the medicinal products used by our children have not been properly tested to ensure the appropriateness of their use.
“Children are not simply small adults and it cannot be right that 90 per cent of the medication given to newborn babies has only ever been tested on adults. This will be a concern for all parents.”
Caffeine is prescribed to large numbers of youngsters with breathing difficulties despite it not being licensed. Other common, but untested, medicines include painkillers such as morphine, paracetamol and ibuprofen.
Some anti-epileptic drugs given to teenagers have been tested only on adults. Asthma inhalers are often prescribed at higher doses than have been tested in children.
‘Drug companies need financial incentives’
The report says that drug companies should be given financial incentives to carry out proper tests on children’s medicines. Most are reluctant to carry out these trials because they cost on average an extra £2.7million per product.
The peers said carefully monitored clinical trials should be carried out on youngsters
The peers said carefully monitored clinical trials should be carried out on youngsters – with the consent of their parents.
Trials on children have not been conducted in the past because of concerns that drugs will do more harm than good and that irresponsible parents would offer their children for testing in return for cash.
The peers said they welcomed plans to set up EU-wide regulations for children’s medicines. They pointed out that the US government has provided incentives for drug testing on children and this was rated a success. They also called for medical products to be properly labelled to indicate their suitability for use by under 18s.
Professor Sir Cyril Chantler, chairman of Great Ormond Street Hospital, told the peers the lack of testing was a ‘serious problem’.
“I simply do not understand how anybody can argue that we should have a lower standard for children than we apply to adults,” he said.
“It is bizarre. But it has been a problem to people like me throughout their careers.”
Another committee member, Lord Moser, called for extensive clinical trials on children.
“The pharmaceutical companies are hesitant because it is very expensive,” he said. “Randomised clinical trials are absolutely essential.”
‘It’s been a concern for years’
Health minister Jane Kennedy said: “The lack of medicines authorised and formulated specifically for paediatric use has been a concern in the UK for years.” But she added that the Government would not support routine clinical trials on children “if we were not absolutely convinced from all the expert advice that this is the right thing to do.”
Sharon Conroy, a lecturer in paediatric clinical pharmacy at the University of Nottingham, said 70 per cent of children and 90 per cent of newborn babies in intensive care units will be given at least one unlicensed or ‘off-label’ medicine.
“It’s not wrong, it’s not illegal, we only ever do it when there’s no alternative,” she said.
“Doctors are having to make the best of it as children do need these drugs.”