Many Kids’ Medicines Not Tested for Safety

By ANDREW, Kelly

Ethical concerns mean that often children’s drugs are tried only on adults.

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MANY of the medicines commonly given to New Zealand babies and children have not been tested for safety in their age group.

A report by the British House of Lords has found that 90 per cent of drugs for newborn babies and 50 per cent of those aimed at children are untested except in adults.

New Zealand health authorities say the situation is the same here and in other countries.

It is difficult to test new drugs on children because of the serious ethical concerns involved.

A House of Lords committee chairwoman, Baroness Thomas, said it was worrying that so many medicines used by children had not been properly tested to ensure the appropriateness of their use.

“Children are not simply small adults,” she said.

Stewart Jessamine, spokesman for New Zealand medicines regulator Medsafe, said most antibiotics, asthma treatments and painkillers prescribed for children had been tested and approved for youngsters.

However, some blood pressure, diabetes and cancer drugs were used on children without first being tested on them.

“That doesn’t mean the drugs are not safe or not effective,” he said.

Paediatricians and doctors made careful decisions on safe dosages based on the way medicines worked in adults, he said.

The Centre for Adverse Reactions Monitoring reported any side effects or reactions by children to medicines and Medsafe took action if necessary.

The House of Lords committee has given its approval to a recent proposal by the European Commission that would require drug companies producing medicines for adults to test their suitability for children.

It would also provide incentives for the development of new paediatric drugs.

At present, there is no legal obligation for a pharmaceutical company to carry out such studies unless it plans to develop the medicine for use on children.

If the commission proposal becomes law it is likely to come into force next year, and would affect drugs available in New Zealand.

Researched Medicines Industry Association chairwoman Pippa MacKay said most prescribers would be unaware that not all drugs for children were specifically tested on youngsters.

“But how are you going to easily test everything you want to use on babies?”

From a pharmaceutical industry perspective, every company wanted to ensure its products were safe for all patients, she said.

However, if clinical trials of all paediatric drugs were required then it could limit the availability of some useful medications for infants and children.