The American Food and Drugs Agency, which regulates drug use in the U.S, has decided that there needs to be a label change for the smoking-cessation medication Champix. The change in the wording of the label will reflect concerns that the treatment may be linked to depression.
The Agency said that the new labelling would warn patients that there was a risk they might experience changes in mood, increased hostility, depression and even suicidal thoughts. However they made clear that the chances of such an event were rare and outweighed by the potential benefits of the treatment.
A representative from the FDA’s Centre for Drug Evaluation and Research, Janet Woodward, said that doctors and patients needed to weigh up whether the massive benefits of stopping smoking, which include lessening dramatically the likelihood of death from cancer or heart disease, merited the risk of experiencing side-effects. She added that any patients suffering from side-effects should immediately stop taking the medication and consult their doctor.
Health experts have however said that it was more likely that smokers would suffer from mental health issues in any case, according to a series of studies. Studies have also noted that quitting smoking can be a fairly traumatic process and cause quite dramatic mood changes, regardless of whether someone is using a nicotine replacement therapy or not.