Two-Year-Long Study to Assess ADHD Drugs’ Heart Risk
US officials confirmed on the 17th September 2007 that that the biggest ever investigation into the effects of drugs prescribed to patients with Attention Deficit Hyperactivity Disorder (ADHD) will soon commence. Spearheaded by two national health agencies, the study will assess what link the medications have to an increased risk of heart problems in their users. In a collaborative venture, the Agency for Healthcare Research and Quality (AHRQ) will work alongside the US Food and Drug Administration. Together, they will analysis clinical data representing approximately 500,000 ADHD patients – both adults and children. The drugs under scrutiny include Adderall – made by Shire Pharmaceuticals, and Ritalin – the product of Novartis AG.
The study is anticipated to take place over a two-year period, and will investigate all the current ADHD drugs on the market – taken by millions of people all over the world.
The investigation is based on fears that these medications could cause heart attacks or other forms of cardiovascular complication. The concerns emanate from the tendency of ADHD drugs to stimulate blood pressure and heart rate.
The study was described in a statement made by the US FDA’s Officer of Surveillance and Epidemiology’s Director – Dr Gerald Dal Pan. In it, he said: "Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment”.
He added: “The goal of this study is to develop better information on this question."
The US Food and Drug administration has come under fire in recent times, with claims that it has been under-active in monitoring previously-approved drugs, once they are on the market – especially when they are linked to serious side effects. A case in point is the infamous Merck-made drug Vioxx, which – when associated with risks of heart attacks and strokes – was withdrawn immediately.
In August last year, the industry regulator requested manufacturers of ADHD medication include information on the prescribing instructions that refers to any cardiovascular concerns. Six months later, it asked the same firms to product plain-text guides that detail the risks – both psychiatric and cardiovascular – attached to the drugs.
As per figures published by the National Institute of Health, up to 5 per cent of children and 4 per cent of adults suffer from ADHD. Typical traits include a shortened attention span, impulsiveness, and random behaviour.
Source – Pharmaceutical International’s US Reporter
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