EMEA makes adverse drug reaction research a priority
pharmafile | August 12, 2009 | News story | Research and Development, Sales and Marketing | Europe, drug safety
Adverse drug reaction in hyperactive children has been made a key research priority for next year by the European Medicines Agency.
The EU-funded work will also look at areas such as medicine use in pregnancy and suicidal behaviour in relation to antidepressants.
The subject areas were decided following findings by the pharmacovigilance working party of the European regulator's Committee for Medicinal Products for Human Use (CHMP).
The European Medicines Agency (EMEA) will look at the long-term effects in children and young adults of gold standard treatment methylphenidate for attention deficit hyperactivity disorder (ADHD).
Earlier this year the CHMP concluded the benefit risk of methylphenidate – the active ingredient in many anti-ADHD brands including Novartis' Ritalin – was favourable.
But its long-term safety has not been systematically evaluated in controlled trials, the EMEA says.
Potential areas of concern include cardiovascular and cerebrovascular risks, psychiatric disorders, carcinogenicity and effect on growth.
Other EMEA research priorities include the long-term adverse effects of immunomodulators, particularly the monoclonal antibody TNF blocker treatments.
Used in the treatment of severe rheumatoid arthritis, multiple sclerosis and other immune system diseases, a variety are currently licensed in the EU.
They include tocilizumab (Roche's RoActemra), infliximab (Schering-Plough's Remicade), etanercept (Wyeth's Enbrel) and adalimumab (Abbott's Humira).
EMEA says use of immunomodulators in young people "is of particular concern because of the increased likelihood of long term immunosuppression".
Last week US regulator the FDA ruled TNF blocker drugs should carry new warnings of the increased risk of certain cancers for children and adolescents taking the treatment.
It found the drugs raised the risk of lymphoma and other cancers and identified new safety information showing some patients developed leukaemia and new-onset psoriasis. But the regulator ruled that the increased risk was not serious enough to require restrictions or withdrawal of any of the drugs.
The EMEA's research is expected to focus on identification of risk factors for developing neurological effects, opportunistic infections or malignancy.
Work should also be done on developing methodologies for early clinical detection of virus or bacterial reactivation or infection in patients, it says.
The other EMEA research priorities for 2010 are:
* Long-term adverse skeletal effects of bisphosphonates
* Medicine use in pregnancy
* Suicidal behaviour in relation to certain drug use such as antidepressants and antipsychotics
* Safety of antipsychotics in demented patients
The research will be carried out under the EC's 7th Framework Programme, and proposals from researchers have already been invited.
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