Citizens Commission on Human Rights

The Mental Health Watchdog

Australian National Office

Australian Psychotropic Drug Warnings and Adverse Drug Reactions


By April 2011, the TGA had received 13,179 adverse drug reactions (ADR’s) linked antidepressants, including 286 deaths, of which 5 were in the 10- to 19-age group.

There were 36 reports of children and adolescents under the age of 19 who experienced suicidal ideation or attempted suicide.

Although antidepressant use for depression in under 18 year olds is not approved in Australia, consider the following examples of ADR’s:

  • A 15-year-old girl taking Zoloft committed suicide and the report states, “Death, maybe drug.”
  • A 14-year-girl on Effexor and an antipsychotic drug committed suicide by hanging herself.
  • Another 14-year-old girl became suicidal although she had no previous history of suicidal ideation.
  • A 6-year-old boy experienced seizures while taking Zoloft.
  • A 6-year-old girl on Zoloft experienced abnormally increased heart rate, nausea and headache and another 6 year old boy suffered convulsions.

The Therapeutic Goods Administration (TGA) is Australia’s drug regulatory agency. They are responsible for authorising the sale of drugs and medical devices in Australia as well as their removal from sale if they are harmful

to the public. They also conduct investigations into drugs and medical devices as well as issue warnings about these.

The TGA have issued warnings since 1995 with regards to psychotropic drugs and done other investigations.

The strongest warning that can be placed on any drug in Australia is called a “Boxed Warning.” In the US this is called a “Black Box Warning.” Sometimes it is also called a “Black Box Warning” in Australia because the US use this term.

This Boxed Warning in Australia is not on the packaging of the drug and it is not on the “Consumer Medicine Information” (CMI) which is given to the consumer. The Boxed Warning is only on the “Product Information” (PI) which doctors, pharmacists and other health professionals use. It is called a “Boxed Warning” because this warning is placed in a text box within the PI. The information is also placed within the CMI but not in the exact same words and not within a box.

Therefore the consumer does not always know that the strongest warning that can be issued for a drug in Australia has been placed on the drug they are taking. It is left to the consumer to independently research the drug further themselves on the internet or in a library and locate the relevant PI for the drug. They can also ask their doctor or pharmacist for a PI or ask them if the drug has a Boxed Warning if they are aware of these boxed warnings.

Not all psychotropic drugs in Australia have information within the packet. In many cases these above situations prevents the consumer from being fully informed at time of prescribing or filling a prescription. Coupled with the fact that not all psychiatrists inform their patients of all warnings and potential side-effects for the drug, patients are not always able to give fully informed consent for any psychotropic drug proposed as treatment.

Click here to download information on all Australia’s drug warnings that have been issued by the government.

Warning: No-one should stop taking any psychiatric drug without the advice and assistance of a competent medical practitioner.