Anti-smoking drug linked to violence

AN anti-smoking drug prescribed under the medical card scheme is 18 times more likely to be linked with violence and aggression compared to other drugs, according to a study.

The research, carried out the by Institute for Safe Medication Practices, in the US, found that Varenicline, known as Chantix in the US and Champix in Europe, had the strongest association with violence by every measure used in the study.

To be disproportionately linked to violence, a drug has to be associated with at least five cases of violence. Statistical analysis also had to indicate that the cases associated with it were unlikely to have occurred by chance.

The drug cost the state more than €5.2 million in 2009 and was prescribed almost 70,000 times under the general medical and drug payment schemes.

Champix has been under scrutiny for some time due to a number of incidents involving sudden changed behaviour.

The Irish Medicines Board (IMB) said the safety of Champix has been closely monitored since authorisation and a review of the available data relating to depression and suicidal thoughts and behaviour was undertaken at EU level in December 2007.

“The IMB fully participated in this review which concluded that there was a need to update the product information to warn doctors and patients that depression has been reported in patients who are trying to stop smoking using Champix,” a spokesperson said.

“The package leaflet, that accompanies this medicine states that there have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking Champix.”

The board said it had continually reminded healthcare professionals that Champix should be discontinued if agitation, depressed mood or changes in behaviour of concern for the GP, patient, family or caregivers are observed, or if the patient develops suicidal ideation or suicidal behaviour.

The US study was published in the Public Library of Science journal earlier this year. Among the top 10 most dangerous are the antidepressants Pristiq (desvenlafaxine), Paxil (paroxetine) and Prozac.

Atomoxetine, an ADHD drug prescribed for children in this country, was found to be nine times more likely to be associated with violence than other drugs.

Researchers used 2004 to 2009 data from the Food and Drug Administration’s adverse event reporting system. They found that during the period, 780,169 serious adverse events had been reported for 484 drugs, and that of those serious adverse events, 1,937 had been acts of violence.