Too often parents and adults are not given at the time of prescription of psychiatric drugs the full information, not just about side effects of psychiatric drugs, but also about non-drug alternatives. It is not possible for anyone to give fully informed consent without all the information about psychiatric drugs, alternatives and how the psychiatric diagnosis was arrived at.

To do anything less than convey all the information to the patient and their family is to deny fundamental human rights for patient welfare and safety.

Warning: It is very important that no one stops taking a psychiatric drug without the advice and assistance of a competent medical doctor.

International and Australian Psychiatric Drug Warnings

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 over 80 warnings since 1995 with regards to psychotropic drugs and done other investigations. There have been more than 230 other psychiatric drug warnings issued by international governments.

CCHR has written a Fact Sheet covering all the Australian psychiatric drug warnings, in layman’s terms. This enables the warnings to be understood by everyone.

These warnings include side effects such as: hallucinations, loss of coordination, increased blood pressure, agitation, akathisia (the inability to remain motionless) and aggression, life threatening heart problems, addiction, depression, psychosis, suicidal ideation and possible death.

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 U.S. 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 when they fill a prescription. The Boxed Warning is only on the “Product Information” (PI) which doctors, pharmacists and other health professionals use for prescribing and side effect information. 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 as the actual “boxed warning” and not within a text box.

This causes a problem because the consumer is not clearly directed to the needed serious warning information about the drug.

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.

An unacceptable situation exists where not all psychotropic drugs in Australia have information within the packet and pharmacists do not always give the consumer drug information. This situation can prevent the consumer from being fully informed of the potential consequences of taking the drug. 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. Once they start treatment and experience negative side effects, it can be too late.

Side Effects of Psychiatric Drugs

More than 18,500 adverse drug reaction reports (ADRs) for antidepressants have been received by Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), with more than 360 of those reporting deaths. Over 15,500 ADRs have also been received by the TGA for antipsychotics (including more than 600 deaths). Australian experts say it is thought that only between 1 and 10% of all ADRs are reported in Australia,¹ so these numbers represent only a fraction of the side effects being experienced by patients/consumers.²

Although antidepressant use for depression in under 18 year olds is not approved in Australia,³ psychiatrists prescribe them off-label (used for conditions a drug is not approved for) with no approval or oversight. Consider the following examples of ADR’s (please note these ADR reports are not medical histories):

• 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 on Zoloft 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.

Prior to 2011, on two separate occasions, CCHR requested the adverse drug reaction reports for antidepressants, antipsychotics and ADHD drugs from the TGA which included the ones listed above. When CCHR requested them again in 2011, the TGA refused to provide them and would only give CCHR summaries of the adverse drug reports.

In 2012 the TGA’s on-line database of adverse drug reports was set up. However the information available on it is limited and the TGA will no longer provide the more comprehensive adverse drug reaction reports to the public. While it is a step of progress that the TGA have set up a database for the public on-line, the more comprehensive adverse drug reaction reports should be made available to the public. The public have a right to know. CCHR provides them here for your use.

To find out the side effects reported to the TGA for psychiatric drugs by generating summary reports on their website, use this link. It is very simple and quick to use: https://www.tga.gov.au/database-adverse-event-notifications-daen

Reporting Side Effects

Many consumers are unaware that they can themselves report adverse side effects directly to the TGA. To report an adverse drug reaction to the TGA:

1. On-line and via email: https://www.tga.gov.au/safety/reporting-problems/report-adverse-event-or-problem-consumers
2. Phone to report to a health professional: 1300 134 237
3. Mail, to download form: https://www.tga.gov.au/resources/resource/forms/blue-card-adverse-reaction-reporting-form

CCHR is organising a petition to help change this situation and ask that the TGA require drug manufacturers to add a prominent boxed advice on the packaging itself informing consumers that they can report adverse side effects directly. Correct reporting of side effects can ensure that needed warnings are placed on the drugs and can result in needed investigations into psychiatric drugs. Please print it off, ask others to sign it and return to CCHR. This is a paper petition, as scanned or photocopied petitions are not accepted by Parliament.

Withdrawal Syndrome

Withdrawal syndrome is a side effect rarely explained at time of prescribing. It can occur when someone stops a psychiatric drug, decreases the dose or switches from one psychiatric drug to another. Doing this without proper medical supervision can cause withdrawal syndrome. This is described as worsening of symptoms and/or new symptoms not before experienced. This can be severe in some cases.

The Australian Therapeutic Goods Administration has issued warnings for withdrawal syndrome and it is something known very well about by the psychiatric industry.

For this reason it is very important that no one stops taking a psychiatric drug without the advice and assistance of a competent medical doctor.

Click here to learn more about withdrawal syndrome.

Numbers on Psychiatric Drugs

Despite all these drug warnings and side effects, in 2020/21, an astounding 4.7 million Australians were on a psychiatric drug.⁴

Currently, vital statistics are being withheld. The number of people by age drug and state on psychiatric drugs is not published every year. These figures should be made public and be completely transparent. With billions of dollars being spent on mental health each year, the tax-payer and consumer have the right to know what is going on. With effective mental health programs in place, that returns people to happy and productive lives, statistics should be improving, not growing.

CCHR Australia now regularly purchases from the Australian Government the numbers on psychiatric drugs by age, drug and state and provides them to the public.

Graphs and tables of the numbers of prescriptions for ADHD drugs are also collated by CCHR from the Medicare website and provided to the public.

From time to time information may and does change. Whilst we endeavour to remain current on important information, it is important that you contact your doctor or Government regulator to ensure you are receiving up to date information.

References

1. Jon Jureidini, “Systematic checks can avert crisis from adverse drug reactions,” The Weekend Australian, 1-2 April 2006.
2. Therapeutic Goods Administration Database of Adverse Event Notifications (DAEN). Generate reports on-line on their website by drug and add reactions together for each drug. https://www.tga.gov.au/database-adverse-event-notifications-daen
3. “Australian Adverse Drug Reactions Bulletin, Vol. 24, No 4,” Australian Government, Department of Health Therapeutic Goods Administration, August 2005. https://www.tga.gov.au/publication-issue/australian-adverse-drug-reactions-bulletin-vol-24-no-4
4. Mental Health Services in Australia, Web Report, Australian Institute of Health and Welfare, Australian Government, Last updated 27 April 2023 https://www.aihw.gov.au/mental-health/topic-areas/mental-health-prescriptions