If you suspect you have experienced an
Adverse Drug Reaction
you should report it.
The Australian drug regulator is the Therapeutic Goods Administration (TGA). They are responsible for regulating prescription drug and issuing warnings to Doctors and consumers when concerns arise. The TGA is also responsible for enforcing restrictions on products that represent a danger to the wider community. They have a reporting service where Doctors and Consumers can report Suspected Drug Reactions.
Click here to report
Although pharmaceutical companies provide evidence by way of trial data when applying for licensing of their products these results are based on “controlled” trials. Controlled trials are where a group of people agrees to participate in a scientific study. These people are under close observation and observe strict guidelines that can extend to behaviour and diet. Once the product is licensed and available for promotion to the wider community the results can be very different due to the lack of control over diet, behaviour, treatment with concurrent medication and suitability such as genetic capacity.
The regulator requires the community to contribute to the reporting process to ensure they have an up to date assessment of the drugs performance in the community.
We urge you to report any suspected side effect from psychotropic drugs to the TGA or you can report it to ACPR, we will ensure that the department responsible records your information for further assessment.
Or you can select to report to both decide the TGA & ACPR the choice is yours, but remember it is important to report any Suspected Adverse Drug Reaction.
Unfortunately, the majority of suspected ADR’s related to this class of drugs are not reported. It is commonly claimed by Doctors, and in particular psychiatrists, that the Adverse Drug Reactions are simply a worsening of the their patient’s condition. For example, a consumer may start an antidepressant for anxiety issues only to find they become more anxious whilst taking the drug. The consumer explains this to their Doctor who increases the dosage of the drug on the assumption that the worsening of the symptoms is unrelated to the drug therapy. In general, these assumptions are made without any psychical evidence such as pathology results or genetic testing.
For consumers taking a psychotropic medication, it is much easier for a prescriber to assume a worsening of a mental health condition (such as an increase in suicidal thoughts, anxiety or akathisia – a state of agitation that can lead to suicide and homicide) is unrelated to the drug therapy. It is more difficult for them to claim that onsite of diabetes or cardiovascular related conditions are a result of the patient’s psychological disorder so these are more commonly accepted as an ADR but unfortunately not always reported.
These drugs can provoke many serious adverse reactions that are not just limited to physical side effects. These drugs can affect the mental capacity of an individual causing depression, anxiety, suicidal ideation, akathisia, hallucinations, night terrors and a state of “unreality”. These, and any of the psychical side effects caused, need to be reported. By doing this, individuals can increase the wider understanding of these drugs and the long-term effects that currently very little is known about.
Important Notice: An Expert Panel employed by the Department of Health and Ageing to investigate concerns about the alarming number of Adverse Reactions related to these drugs, advised in their recommendations that warnings regarding Akathisia should be included in the next Bulletin published by the TGA (to date this has not be included).
Warning: Akathisia is a very serious condition and left untreated the patient may experience psychotic episodes that can lead to aggression and/or homicidal ideation. These types of drugs cannot simply be stopped as there can be additional reactions experienced by those patients who suddenly stop taking their medication (withdrawal symptoms). Immediate 24 hour medical supervision is required for these patients and withdrawal from the medication must take place in a safe medical environment. Any person experiencing Akathisia is a potential risk to themselves and others.
Unfortunately, this condition is commonly treated by giving a patient more of the same type of drug that provoked the Adverse Reaction. This only leads to more severe reactions and sadly has been recognised in the psychiatric field as a justification for Electroconvulsive Therapy (electric shock treatment) or psychosurgery (originally referred to as lobotomies).
Many will be shocked to hear that ECT and psychosurgery is still occurring today, but sadly many adults and children are forced under the Mental Health Act to undergo this barbaric treatment. There is no scientific evidence to support ECT and since the 1950’s this treatment has resulted in severe brain damage and/or death to tens of thousands of patients.
Suspected Drug Reaction
If your symptoms have worsened after being treated with one of these drugs, it is reasonable to suspect your drug as the cause. More common Adverse Drug Reactions such as headaches, nausea, dizziness, blood pressure fluctuations, agitation, nervousness and sleeping problems still need to be reported to further the understanding of these drugs.
You do not need your Doctor to report the reaction on your behalf.
Any reaction reported directly to the pharmaceutical manufacturer must legally be reported to the TGA by the manufacturer on your behalf. If you choose to report your drug to the manufacturer we encourage you to request a copy of their report.
You can electronically report your suspected drug reaction to the TGA, by phone or by via mail, the form you require is a (Blue Card). Alternatively you can contact us directly and we can report your Adverse Reaction on your behalf.
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