Citizens Committee on Human Rights

The Mental Health Watchdog

Australian National Office

Psychiatric Adverse Drug Reaction Reports from Australia’s Drug Regulatory Agency

Anyone can report side effects from drugs to Australia’s drug regulatory agency the Therapeutic Goods Administration (TGA). The TGA is responsible for regulating drugs in Australia including the monitoring of their safety.

In May 2015, the TGA reported that 51% of all adverse drug reaction reports were received by the TGA via drug companies. Only 13% of all adverse drug reactions were reported directly to the TGA by hospitals, 8% from community pharmacies, 5% by GPs and a tiny 3% by consumers.1

In 2014/15, 3.9 million Australians were on a psychiatric drug.2

Astoundingly experts have said it is thought that only between 1% and 10% of side effects are reported in Australia.3

Therefore the number of incidents of serious side effects is likely very much higher than are reported.

CCHR has previously obtained the adverse drug reaction reports (ADRs – named Public Case Details) of various classes of psychiatric drugs several times. CCHR provides them here as a service to the public and in the interests of full transparency.

This information was originally very detailed but in 2011, the TGA began to limit the information provided to the public concerning adverse drug reports. This change could be seen as a liability to the consumer who should have access to comprehensive adverse drug reaction reports. Full disclosure of all adverse reactions should be widely available, not just abbreviated summaries especially those resulting in suicide attempts and death. Mandatory reporting is currently only required of drug companies and this should be extended to doctors, pharmacists and hospitals to protect the consumer and allow informed choices based on facts.

The reports below cover the ADRs (Public Case Details) and summaries of the ADRs reported in Australia for ADHD drugs, antidepressants and antipsychotics.

In 2012 the TGA’s on-line database of adverse drug reports was set up. However the information available on it is much more limited than what is provided here in the Public Case Details. It is also not possible to get a summary of the total adverse drug reactions reported for a class of drugs such as all antipsychotics, using the TGA’s on-line database. A report has to be generated for each drug in the class and the reactions then added up manually. 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 still be made available to the public.

The instructions on how to obtain ADRs from the TGA’s on-line database (summaries only) are below on this page.

Warning: The information enclosed in these documents is not intended to supplement medical advice or be used to guide medical/therapeutic decisions. These Adverse Drug Reports are not medical histories.
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No one should stop taking any psychiatric drug without the advice and assistance of a competent medical doctor due to withdrawal syndrome (worsening of symptoms ― new ―not before experienced symptoms). The TGA has issued warnings concerning withdrawal syndrome.


Instructions on how to view the TGA Adverse Drug Reactions (Public Case Details) obtained by CCHR

Names of Drugs

Psychotropic drugs usually have 2 names, the generic name and the trade/brand name. For example Ritalin is the trade/brand name of an ADHD drug and the generic name is methylphenidate. Zyprexa is a trade/brand name of an antipsychotic and the generic name is olanzapine. The files below are labelled by generic name. CCHR has compiled a list of psychiatric drugs by generic name with common brand names.

Summaries of Adverse Drug Reactions

It is a good idea to look at a summary of the ADRs for the drug first, as this gives an idea of the sort of information contained in the “Public Case Details” files and what types of reactions are reported.

Also included are the explanations provided to CCHR by the TGA on how to read the summaries of the ADRs.

How the Adverse Drug Reactions are Organised on this Website

The ADR reports are sorted by the year that CCHR obtained them (2007 & 2009 & ADR summaries only for 2011). This means to find all the Ritalin adverse reactions for example, you will need to search the Ritalin reports for each year to obtain them all.

For example if the 2007 year is reviewed, it will have all the adverse reactions reported up to 2007.

The 2009 file will only have the adverse drug reactions reported between 2007 and 2009.

The summaries in each year are for the entire time period up to that date: the 2007 summary files have all the ADRs reported up to 2007. The 2009 files have all the ADR summaries reported up until 2009 and the 2011 file has all the ADRs summaries reported up until 2011. This means if you look at the 2011 summary, it will have the total numbers of side effects reported up to 2011. There are no ADRs for 2011.

In some cases there are reports of side effects titled, “Case Line Listings” (not Public Case Details). These are another form of report and were used by the TGA for some drugs for the earlier years of reporting. This type of report was due to how side effects were reported many years ago. Public Case Details could not be compiled with the information provided at that time.

Use the “Find” to Locate Specific Adverse Drug Reactions

Use the “find” when searching the adverse reactions reports and summaries to search for specific reactions.

Tips:

  • To obtain reactions for suicide, put in “suicid” (not the full word) and this will locate other types of suicidal behaviour/ideation as well as completed suicides.
  • Sometimes you may need to search using various ways of spelling a potential reaction. For example if you are searching for all reactions to do with violence, you would need to include the following in the search: violence, aggression, hostility, rage, homicidal etc to obtain all the reactions related to violence for a drug.

Here are the links to the adverse drug reactions reported to the TGA

How to find out the side effects reported to the TGA for any drug in Australia for any time period on the TGA’s website

Tablet with the text side effects on the display.The TGA have a database of side effects reported by doctors, chemists, drug companies and the public for all drugs available on their website. It is very simple to generate side effect reports for psychiatric drugs using this database. These reports generated include the number of deaths linked to the drug.

Each time a report is generated for a drug, two reports are generated (Medicine Summary and List of Reports). Do look at both of them. It is also a good idea to download the reports (click where it says “print version of this report”) as they can then be fully searched for specific side effects. If you don’t do this you can only search what appears on the screen.

See under “Adverse Events” on the TGA homepage or use this direct link to access the database: https://www.tga.gov.au/database-adverse-event-notifications-daen

How to Report Side Effects

6024357 - Hand picking up an office phone.Many consumers are also unaware that they can directly report adverse side effects to the TGA. If enough of the adverse reactions occurring are reported, the true picture of the potential dangers of psychiatric drugs will become evident.

The TGA is responsible for monitoring the safety of drugs in Australia. Even if you are just suspicious, the TGA requests consumers report to them. Reporting side effects can cause:

  1. New drug warnings to be placed on the drugs
  2. The TGA to take regulatory action to protect the public
  3. The TGA can cancel the registration of the drug.4

To report an adverse drug reaction to the TGA

Always call 000 in an emergency.


References

  1. “Medicines and vaccines pot-market vigilance-statistics for 2014” Australian Government Department of Health, Therapeutic Goods Administration, 26 May 2015. https://www.tga.gov.au/medicines-and-vaccines-post-market-vigilance-statistics-2014https://www.tga.gov.au/australian-statistics-medicines-and-vaccines-2013
  2. Mental Health Prescriptions 2014-15, Australian Institute of Health and Welfare, Australian Government, July 2016; https://mhsa.aihw.gov.au/resources/prescriptions/
  3. Jon Jureidini, “Systematic checks can avert crisis from adverse drug reactions,” The Weekend Australian, 1-2 April 2006.
  4. http://www.tga.gov.au/reporting-adverse-events