Attention-deficit drug linked to suicide risk
The Irish Medicine Board (IMB) has posted a special alert on its website following a Europe-wide review of the risks and benefits of Atomoxetine that has been available in Ireland since January 2007.
The IMB said the review was conducted because of concern about the increased risk of suicidal thoughts and behaviour associated with the drug, also used to treat adolescents, as part of a comprehensive treatment programme.
It has told doctors that patients being treated with the drug should be monitored for signs of depression, suicidal thoughts and referred for appropriate treatment, if necessary.
ADHD is a problem related to brain development that causes hyperactivity, impulsive behaviour and attention problems.
The IMB has warned that the drug can also cause seizures and should be “introduced with caution” if a patient has a history of seizures. There is also a risk of rare, but sometimes severe, liver disorders.
While the review concluded that the balance of risk and benefits of Atomoxetine remains positive, the IMB decided to issue the safety warning to optimise the safe use of the drug.
The Irish regulatory body also points out that adverse reactions reported in Ireland had been consistent with the known safety profile of the product.
Atomoxetine is manufactured by Eli Lily and a spokesperson for the global pharmaceutical company said numerous regulatory bodies had approved the drug as a well-tolerated and effective ADHD medication.
“There are benefits and risks associated with every medication and we would encourage physicians to discuss these fully with their patients or family members so they can understand what the best treatment options are for them,” he said.
The spokesperson said the drug had been the most extensively studied psychiatric medication for children, with more than 8,000 patients taking part in clinical trials, some for as long as five years.
The drug had been used by 5.5 million patients worldwide since its first approval in the US in 2002.



