Look out for the warning signs


TGA reminds health professionals to communicate the potential risks of medicines associated with neuropsychiatric adverse events

The TGA has issued a reminder to health professionals on communicating the potential risks and benefits associated with some medicines treatments that may lead to neuropsychiatric adverse events.

Neuropsychiatric adverse events can range from mild to severe, and encompass a broad range of symptoms including:

  • Tremor
  • Agitation
  • Aggressive behaviour or hostility
  • Anxiousness
  • Depression
  • Dream abnormalities
  • Hallucinations
  • Insomnia
  • Irritability
  • Restlessness
  • Somnambulism [sleep-walking]
  • Suicidal thinking and behaviour

Neuropsychiatric adverse events occurring in association with medicines, particularly suicidal thinking and behaviour, are a source of serious concern for consumers, says the TGA.

These types of events are a known risk associated with a number of medicines, including:

  • Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs)
  • Certain smoking cessation medications, including varenicline and buproprion (marketed as Champix and Zyban respectively)
  • Certain antiepileptics, including sodium valproate, carbamazepine, levetiracetam, phenytoin, lamotrigine, topiramate, pregabalin and gabapentin
  • Isotretinoin (marketed as Roaccutane)
  • Atomoxetine (marketed as Strattera and generic brands)
  • Montelukast (marketed as Singulair and generic brands).

For all of the medicines listed above, the observed association with neuropsychiatric adverse events may be confounded by indication, because the medical conditions being treated are themselves known to be associated with an increased risk of altered mood, which may lead to suicidal thinking or behaviour.

For this reason, it is often difficult to establish a definite causal relationship between a medicine and a severe neuropsychiatric adverse event, says the TGA.

Several studies have shown that patients with mental illness and their carers feel that they have not received enough information about their treatment with antidepressants, says the TGA.

One survey found that just over half of the inpatients and one third of community based patients reported that they did not receive any medicines information.

Carers were even less likely to report receiving medicines information or to be included in discussions or decisions regarding medicine use.

TGA strongly encourages health professionals to provide patients with the relevant Consumer Medicine Information, which is available through medical and pharmacy software, for any new medications from the above list they are prescribed.

Health professionals are also encouraged to provide additional education to patients who are taking the above medications and to undertake regular monitoring for changes in mood or behaviour.

Patients and their carers should be advised to seek medical advice if they notice any changes in the patient’s behaviour.

There are additional resources available for health professionals and consumers to help them make informed decisions about the use of antidepressants and to better education patients and carers about their treatment, including information on the NPS MedicineWise website.

Another important topic to discuss with patients when appropriate is discontinuation and potential discontinuation symptoms.

“It is important for patients and carers to be educated about the importance of not suddenly stopping treatment, especially when taking antidepressants and antiepileptics,” says the TGA.

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