We, the undersigned, call upon Prime Minister Julia Gillard and the Federal Health Minister, Nicola Roxon, to instruct the Australian Therapeutic Goods Administration (TGA) to:

1. Include a Black Box Warning on all psychotropic medication to include all antidepressants & antipsychotics as well as extending this warning to Champix used to treat patient's attempting to give up smoking and Roaccutane commonly prescribed to teenagers for Acne, as these two drugs have also been linked to provoking suicidal ideation and behaviour changes. The Black Box Warning will ensure that prescribers and consumers are aware of the serious risks asscociated with these types of drugs and will be able to make an informed decision.

1. Suicidal ideation and behaviour;
2. Worsening depression and anxiety;
3. Akathisia, a state of agitation and restlessness that can cause psychotic episodes resulting in suicide or homicide;
4. Serious health conditions such as diabetes and cardiovascular issues.

We expect that the Black Box warning will compare to the warnings issued by the Food and Drug Administration (FDA) in the USA.

2. Include as part of the prescribing guidelines, Recommended Pharmacogenomics testing of the CYP450 genes. This will provide prescribers with scientific evidence so as to establish the metabolic capability for a patient/consumer to benefit from a particular drug therapy. The benefits include:
   1. Assisting in finding the most suitable therapy for a patient/consumer and curb the dangers of the ‘trial and error’ process;
   2. Reducing the number of patients presenting at hospital for care after experiencing an Adverse Drug Reaction (ADR);
   3. Save the Australian Government and taxpayers billions of dollars per year, as was outlined in the Australian Centre for Heath Research, Improving the Quality of Use of Medicines in Australia (Realising the Potential for Pharmacogenomics). This report concluded that Pharmacogenomics testing could save the nation $12 billion dollars over the next ten years.
   4. Reduce the pain and trauma that is caused to patients and their families as a result of the ADR’s that provoke suicidal ideation and/or behaviour.

We demand that the Government invests in pharmacogenomics education and awareness so all prescribers, including General Practitioners, have a clear understanding of the importance of their patient’s genetic capability for particular drug therapies, and where to obtain the relevant testing. We also demand that this testing is accommodated via Medicare, with conditions that would avoid discrimination to patients/consumers and/or carers.

The evidence suggests that at least 10% of Caucasians are poor metabolisers for CYP2D6, and 20% of Asians are poor metabolisers for CYP2C19, the two genes that are involved in the metabolism of most antidepressants. The high occurrence of ADR’s to these, such as worsening depression and suicidal ideation, may possibly explain the mental health crisis that has occurred since the Federal Government decided to rebate these drugs via PBS in the early 90’s.

3. The Federal Government moves to regulate Australian ‘Informed Consent’ procedures to ensure all prescribers are legally obliged to:

1. Obtain a signed Informed Consent form that states all the possible adverse reactions to these drugs as well as information relating to the dangers and implications of withdrawal and possibility of the patient relying on these drugs indefinitely. This form should also include information relating to the availability of pharmacogenomic tests.
2. To explain any side effect or potential illness caused by these drugs if the patient/consumer does not fully understand.

The fact that there are over 25,000 reported Adverse Drug Reactions for antidepressants as of 2008 raises serious concerns that the TGA has failed to adequately and responsibly regulate these drugs. 

When you consider that the Government agreed to include a Black Box warning for Stilnox for only 1032 Adverse Reactions, the failure to include black box warnings for antidepressants and antipsychotics where related Adverse Reactions exceed the Stilnox adverse reactions by 10’s of thousands could easily be argued as gross negligence.

It is unacceptable that there are tens of thousands of serious adverse reactions reported in relation to these drugs, which include over 500 deaths, yet they are still available without effective warnings.  By instituting a legal informed consent process, these figures may reduce in future.

4. Finally, we request that the Government intervene immediately to ensure the restrictions for these drugs in children and adolescents under 18 years are listed on the PBS in accordance with the PBAC guidelines and the eligibility criteria that is dictated to sponsors (pharmaceutical companies). We request that the restrictions include the updated recommendation from the TGA that advised that these drugs are not recommended for persons under 24yrs as the safety and efficacy had not been proven in this age group.

The PBAC’s policies clearly document that the sponsors must have licensing for the specific indications to be considered for funding via PBS and this is extended to age indication, as was documented in a report commissioned by Mr. Bill Shorten, Parliamentary Secretary for Disabilities and Children’s Services, complied by an officer of the Parliamentary Library.

As stated above, Black Box warnings need to be provided on these drugs so parents/carers are also aware that these drugs are not approved or recommended for children and adolescents. Evidence from clinical studies has shown that the risks outweigh the benefits of using these drugs in persons under 24 years of age due to the high risk of provoking suicidal ideation and behaviour. In accordance with the regulator’s standards of “effectiveness”, these drugs do not meet standards of safety and efficacy.

This is reflected in the policies and guidelines of the TGA who adopted several international guidelines including the ICH European Guidelines and the CIOMS guidelines.

In conclusion, although the TGA claims to have monitored these drugs for the past twenty years and has recently published The Report of Psychiatric Drug Safety - Expert Advisory Panel, we claim they have failed. The evidence available in the report clearly states that even the Advisory Panel were not confident that prescribers of psychiatric medications have either the knowledge or understanding to be charged with the prescribing of these dangerous and mind-altering medications because of the implications of polypharmacy, as well as the failure to acknowledge that pharmacogenomic testing can contribute to the safe use of these drugs.

The Expert Advisory Panel’s decision to not recommend Black Box warnings on these drugs on the premise that extensive information if provided about the risks in the product information is misleading. The Consumer Medicines Information sheet (CMI) lists but does not emphasise, the serious adverse effects of these drugs including; increased risk of suicidal ideation and behavioural consequences such as akathisia. Furthermore, as the drug companies often do not provide the CMI with the drug there is a potential danger that it may be omitted by the dispensing pharmacy. This situation is contrasted by the FDA Black Box warning in the USA, which is on the CMI and in some cases printed on the packaging.

The failure of the Government to act on these requests when presented with an enormity of scientific evidence and an alarming number of ADR’s is grossly negligent. We, the people, submit this petition and demand the Government acts in the interest of the Australian public for health and safety reasons and instigates that changes stated in this petition as a matter of national urgency.

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