French study gets ‘children’ drug approved in Canada, has US, Aussie doubts

Media playback is not supported on this device ATEa approves Pfizer for kids drug Bruce Arthur’s tablet covered in Granta china, covered in white icing and nestled snugly inside it: ‘I have never had…

French study gets 'children' drug approved in Canada, has US, Aussie doubts

Media playback is not supported on this device ATEa approves Pfizer for kids drug

Bruce Arthur’s tablet covered in Granta china, covered in white icing and nestled snugly inside it: ‘I have never had a high school drug such as this,’ my daughter said, holding it over her mouth and smiling. ‘It has a chatper on it.’

This Ate My Meds-style bottle had a calendar inside, with numbers and numbers, graphs of benefits and potential harms; it was more familiar than drugs prescribed in the real world, she said.

This was one of the first experiences of having something from the Therapeutic Goods Administration, the government body that ensures we can safely use all medications, approved for children in Canada, and had been for more than a decade.

In August, after a trial period in Quebec, Therapeutic Goods Advertising Standards Board (TGAASB) approved Pfizer Canada to market the branded version of a generic drug sold in Canada as Enbrel, used to treat rheumatoid arthritis.

While some – in America and Australia – debated its use for kids, a number of doctors and manufacturers questioned its effectiveness in children for Rheumatoid Arthritis, however.

There are estimated to be nearly 4 million adults living with Rheumatoid Arthritis in North America, and another 3 million people are living with another form of arthritis.

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There are two known uses for the drug in children.

It’s already approved to treat rheumatoid arthritis in adults and is a daily pill taken as needed.

In a statement from Pfizer, the company says the drug is intended for use in children ages one to 17 with an active disease in acute phase disease – meaning a rash or redness on the skin – where symptoms may not improve after standard therapy.

But Dr Penny Baillie of the Maudsley Hospital in London, England, says most children with arthritis have mild disease and that until now the drug has been difficult to prescribe and important to study.

“I know we have a black box warning [against use in children] in the UK for Enbrel – for children who have a low tolerance to the medication,” she said.

Adults typically have at least an 80% tolerate rate, and most children aged one to 17 have a tolerable tolerability rate of 55% to 65%, meaning a small percentage of children with rheumatoid arthritis would experience severe adverse events.

“It’s a prescription that I have a reasonable degree of confidence in. I know that although the effects can be unpleasant, if I use it I’m quite confident that what I’m putting in my child’s body will be fairly harmless,” Dr Baillie said.

Pfizer, by comparison, says its average tolerability in children under the age of five years is 57%.

No other marketer of this drug in the world has had their claim for youth market approval approved.

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Here, the drug is called Lyrica; it’s used to treat pain caused by nerve and muscle damage as well as to treat seizures, glaucoma and migraine.

Like other drugs, it is tested in children and results are considered by the Federal Government, which then recommends it for a Pharmac list of medicines that is part of Canada’s National List of Medicines.

Parents have no input, and it’s up to medical doctors.

Critics say Pfizer should be held to a higher standard as the manufacturer of the drug.

The drug has been rejected and rejected again – not just from the government, but from other international bodies.

It was even turned down from Ate My Meds-style bottles for children in the USA and Australia.

In Canada, no major outbreak has been documented from Lyrica use in children. But experts say they can only develop data to support its use after it’s been overused, and evidence of more serious side effects still needs to be gathered.

Those are things that would need to be considered before Pfizer will be able to start selling its drug to other countries.

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