There are over 105 Australian Government psychiatric drug warnings. Provision of information about these warnings are a vital component of every patient’s right to fully informed consent. The Therapeutic Goods Administration (TGA)

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 drugs and medical devices.

Below are the warnings that the TGA has issued since 1995 with regards to psychiatric drugs along with other safety advisories, investigations the TGA has performed and information they and the Government has issued.

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 when they fill a prescription. 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 at the top of 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.

Even the CMI is not always given to a consumer each and every time they fill a prescription for a psychiatric drug and not all psychiatric drugs in Australia have information within their packets. The above situations can prevent the consumer from being fully informed at time of prescribing or filling a prescription. Coupled with the fact that psychiatrists too often do not inform their patients of all warnings and potential side effects for the drug, patients are often not able to give fully informed consent for any psychiatric drug proposed.

All Boxed Warnings should be on the packet of the drug so consumers are easily able to be more fully informed.

Many consumers are also 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, log onto: tga.gov.au/safety/reporting-problems
2) phone: 1300 134 237

Drugs can have two names: Most drugs have two names, the generic name of the drug and the brand name of the drug, eg. fluoxetine is the generic name and Prozac is one of the brand names of fluoxetine.

Side effects reported to the TGA for psychiatric drugs in Australia: The TGA have a database of all the side effects reported by doctors, chemists 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. Click on “Database of Adverse Events Notifications (DAEN)” on the TGA homepage: tga.gov.au

NOTE: 1) Prior to 2010 the TGA issued “Adverse Drug Reactions Bulletins” containing critical safety drug warnings. Since January 2010 these have been called “Medicine Safety Updates” or “Safety Updates.”

2) Since April 2022, there is a “Product Information Safety Update published monthly, to warn of some (not always all) new safety-related information that result in Product Information safety changes that may not have been published in a “Medicines Safety Update.”

3) The TGA also issues “Safety Alerts” during the year which can relate to drug safety and drug recalls. Relevant Safety Alerts are included in the below.

WARNING: No one should stop taking any psychiatric drug without the advice and assistance of a competent medical doctor.

2024

November − A TGA warning was issued for bupropion causing alopecia ̶ hair loss. Bupropion is an antidepressant (Zyban) used in smoking cessation. Use may unmask a rare genetic disorder causing irregular heartbeat that can cause fainting, seizures or sudden death (Brugada Syndrome).¹

October − The TGA warned that lithium carbonate (lithicarb−antipsychotic) can cause a noncancerous tumour that grows in the parathyroid gland (parathyroid adenoma). The parathyroid glands are located in the neck, near the thyroid gland. It can also cause parathyroid hyperplasia the TGA stated (a condition where the four parathyroid glands in the neck are larger than normal that can cause high levels of calcium in the blood, which can lead to bone loss and broken bones).²

August − The TGA issued a Product Information Safety Update for several psychiatric drugs including the ADHD drug methylphenidate (Concerta). The following side effects were added to the PI: a compulsive desire to pull out ones hair, obsessive thoughts and compulsions.

There was also a warning for fluoxetine (Prozac) after studies mainly conducted in people over 50 years of age, have shown that patients who take SSRI’s and TCA’s (both a class of antidepressants) are at risk of bone fractures.

The PI for clozapine (Clopine−antipsychotic) was updated to add additional information about the life-threatening conditions that can occur due to this drug, when the body has very low levels of white blood cells (Agranulocytosis/neutropenia). The warning also included more information about the risk of high blood pressure when standing, bradycardia (low heartbeat), loss of consciousness caused by a fall in blood pressure (syncope) and intestinal perforation, ulceration or necrosis (gangrene). Side effects added included the risk of appendicitis and appendicitis perforated.³

July − The TGA warned that the antidepressant bupropion (Zyban used in smoking cessation) is contraindicated for children.⁴

May − In an updated warning document, the TGA said that all SSRIs and SNRIs (classes of antidepressants) have the risk of sexual dysfunction persisting after the antidepressant is stopped. “These effects can persist for weeks to years,” said the TGA.⁵

May − The TGA advised in a Product Information Safety Update that the risk of suicidality and suicidal ideation was added to the Product Information as an adverse reaction for the ADHD drug Vyvanse, (lisdexamfetamine). The TGA said that it is not known how common this is.⁶

March − The TGA’s Product Information Safety Update covered the following:

Dexamfetamine (ADHD drug), the boxed warning for the ADHD drug to be changed to include that chronic misuse “can lead to addiction, marked tolerance and psychological dependence with varying degrees of normal behaviour.” Death can also occur if taken in higher doses. New information was added to the PI that misuse can result in death, the drug can be diverted for illicit use and misuse, abuse and addiction should be frequently monitored for. New overdose symptoms include seizures, coma and sudden cardiac death.

Lisdexamfetamine (ADHD drug−Vyvanse) can cause sudden twitches, movements or sounds (Tourette’s syndrome).⁷

February − The antipsychotic cariprazine (Reagila) to warn that it has caused a serious skin condition called Stevens-Johnson syndrome. While rare, it is acute, serious and potentially fatal said the TGA’s in its Product Information Safety Update.⁸

2023

December − A Product Information Safety Update covering amitriptyline (Endep) warned of overdose in children which according to the TGA, could have serious consequences and children are especially susceptible to coma, cardiotoxicity, seizures, irregular heartbeat and other side effects of overdose.⁹

November − The TGA issued a Product Information Safety Update covering the following new warnings for psychiatric drugs:

Desvenlafaxine (Pristiq, an antidepressant) to update the guidance on discontinuing the drug. The Product Information states there have been reports of serious discontinuation symptoms which can be protracted and severe. Suicide/suicidal thoughts and aggression have been observed in patients including during discontinuation. The warning says that patients should be monitored during discontinuation, gradual reduction rather than abrupt cessation. Some patients may take months or longer to discontinue the drug.

The antidepressants sertraline (Zoloft), duloxetine (Cymbalta) and fluvoxamine (Luvox and Movox) to warn they can increase the risk of postpartum haemorrhage within the month prior to birth.

Fluoxetine (Prozac), Duloxetine (Cymblata) and Fluvoxamine (Luvox and Movax) “may cause symptoms of sexual dysfunction with reports of long-lasting sexual dysfunction despite discontinuation” of the drug.

The benzodiazepine Midazolam (B.Braun brand) to warn of the cardiac disorder kounis syndrome. Symptoms include chest pain and cardiac failure and are caused by an allergic reaction to this drug. The new warning states this occurs particularly with forms that bypass the digestive tract such as injection.¹⁰

October − The antidepressant paroxetine (Aropax) can cause symptoms of sexual dysfunction with reports of long-lasting sexual dysfunction despite discontinuation of the drug stated the TGA in a Medicines Safety Update (Product Information Safety Update). The TGA also updated the risks to infants with the benzodiazepine midazolam (a sedative). It is excreted in breast milk during breast feeding and can cause drowsiness/sedation, feeding problems and poor weight gain in infants.¹¹

September − The TGA issued a Medicines Safety Update (Product Information Safety Update) for Cipramil and Lexapro, (antidepressants) to add a warning for persistent sexual dysfunction. The TGA stated there have been reports of long-lasing sexual dysfunction where symptoms have continued despite discontinuation of SSRIs and SNRIs (classes of antidepressants).¹²

August − The TGA issued a Medicines Safety Update (Product Information Safety Update) concerning the following psychiatric drugs:

Escitalopram (Lexapro an antidepressant) to warn of the risk of a higher-than-normal level of the hormone prolactin (responsible for development of mammary glands in breast tissue, milk production and lactation) which can cause sexual dysfunction, infertility and discharge from breasts (hyperprolactinemia− this can affect both males and females).

Lisdexamfetamine (ADHD drug−Vyvanse) to warn of the loss of hair (alopecia).

Moclobemide (antidepressant−Aurorix and Amira brands) to warn taking it at the same time as the opiod buprenorphine, can cause life threatening serotonin syndrome which occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea.

Zolpidem (sedative/sleeping tablet – Somidem) warning that it can cause double vision, vertigo. Frequency of side effects for confusion and ataxia (loss of ability to coordinate muscle movements) were updated. Confusion is common and ataxia rare.¹³

July − The TGA issued a Medicines Safety Update (Product Information Safety Update) concerning the following psychiatric drugs:

Methylphenidate (ADHD drug−Concerta) to warn of enlarged breast tissue in males (gynaecomastia) and nose bleeds.

Olanzapine (antipsychotic-Zyprexa) to warn of the risk of sleep walking and sleep-related eating.¹⁴

April-May − The TGA issued a Medicines Safety Update (Product Information Safety Update) for the antidepressant citalopram (Cipramil), to warn of the risk of a higher-than-normal level of the hormone prolactin (responsible for development of mammary glands in breast tissue, milk production and lactation) which can cause sexual dysfunction, infertility and discharge from breasts (hyperprolactinemia- this can affect both males and females).¹⁵

March − The TGA issued a Medicines Safety Update (Product Information Safety Update) concerning the following psychiatric drugs:

Lisdexamfetamine (Vyvanese) to add epistaxis (nose bleeds) and intestinal ischemia to the “Adverse Effects (undesirable effects)” of the PI for lisdexamfetamine. Intestinal ischemia is a decrease in blood flow to the intestines which can lead to damage of intestinal tissue which can possibly lead to death.

Fluvoxamine (immediate release-Luvox) to warn that it should not be used with the sedative ramelteon.¹⁶

2022

November − The TGA issued a Medicines Safety Update (Product Information Safety Update) to warn that sertraline (Zoloft− antidepressant) can cause eosinophilic pneumonia, a group of infections affecting the lungs. A type of white blood cell builds up in the lungs and blood causing inflammation and damage.¹⁷

July − The TGA issued a Medicines Safety Update (Product Information Safety Update) concerning the following psychiatric drugs:

Chlorpromazine (antipsychotic ̶ Largactil) should never be given to children younger than one-year-old due to the risk of sudden infant death syndrome (SIDS). New warnings also for renal and liver dysfunction, acute withdrawal symptoms and neuroleptic malignant syndrome, (NMS, abnormally high body temperature causing destruction of tissue which can be potentially fatal). Warnings also that it can prolong labour, children born to a mother on chlorpromazine can suffer neurological disorders such as involuntary movements, tremor and agitation and it can cause drowsiness, affecting ability to drive and operate machinery.

Periciazine (antipsychotic ̶ Neulactil) to update safety warnings for acute withdrawal symptoms such as vomiting, involuntary movements, involuntary contraction of muscles and insomnia. Other new warnings include for monitoring for QT prolongation (extended interval between heart contracting and relaxing which can lead to death from abnormal heartbeats), the need for monitoring of complete blood count due to potential for a sharp drop in white blood cells causing high fever which is life-threatening and warning also of the inability to control movements especially in children and the elderly. It should not be used during pregnancy or when breastfeeding.

Quetiapine (antipsychotic ̶ eg.Aliquen, Alkem, Quetin) to warn that prescribers should consider ceasing the drug if it causes cardiomyopathy (deterioration of the heart muscle) or myocarditis (inflammation of the heart muscle) both of which are potentially fatal.¹⁸

June − A Medicines Safety Update (Product Information Safety Update) was issued covering new side effect warnings for 3 psychiatric drugs:

Methylphenidate (ADHD drug ̶ Ritalin and Artige) to warn that it should not be prescribed with antipsychotics due to the risk of extrapyramidal symptoms (involuntary movements and muscle rigidity).

Citalopram (antidepressant) should be ceased if seizures develop or if there is an increase in seizures. It should also not be prescribed with opioids.

Aripiprazole (antipsychotic ̶ Abilify) to warn that it can cause decreases in blood prolactin which can cause lactation failure after childbirth or poor semen mobility.¹⁹

April − The TGA issued a Medicines Safety Update covering 3 psychiatric drugs warning of critical new side effects:

Amilsulpride (antipsychotic ̶ Solian) to warn of musculosketal and connective tissue disorders including the risk of rhabdomyolysis, a potentially fatal disease caused by rapid destruction of skeletal muscle. Symptoms can include inflammation, swelling and weakness of the muscles and dark urine the colour of tea.

Lisdexamfetamine (ADHD drug ̶ Vyvanese) adding in a new “Special warning and precaution” for QTc interval prolongation. A QT interval is part of the cycle of a heartbeat. A prolongation of the QT interval increases the risk of sudden death from abnormal heartbeats. The “c” means corrected after the electrocardiograph test is interpreted.

Phenobarbital, (barbiturate, a sedative ̶ Phenobarb). Women of child bearing age should have a pregnancy test prior to taking this drug as it can cause fetal harm (congenital malformations- birth defects). They should use “highly effective contraception” during treatment and for 2 months after ceasing the drug.²⁰

April − The TGA placed a Boxed Warning onto the antipsychotic clozapine to warn of severe gastrointestinal adverse reactions (such as constipation) that have resulted in hospitalisation, surgery and death. By March 2022, there were 1,523 side effect reports of gastrointestinal disorder for clozapine reported to the TGA. These included 260 reports of constipation, 146 of intestinal obstruction, 93 of abdominal pain and 41 of small intestinal obstruction. Of the 1,023 deaths reported for clozapine, 103 were due to gastrointestinal disorders.²¹

2021

July − The TGA advised that Ritalin, Concerta and other brands of methylphenidate can cause foetal cardiac malformations in women taking it in their first trimester of pregnancy. This drug has been re-classed as a “Category D” drug, which applies to drugs that have caused, suspected to have cased or may be expected to cause, an increased incidence of foetal malformations or irreversible damage.²²

July − In a Medicines Safety Update the TGA warned that the antidepressant bupropion (Zyban used in smoking cessation and Contrave used in management of weight) can increase the risk of serotonin syndrome when combined with other antidepressants (SSRIs or SNRI’s – classes of antidepressants) already known to cause serotonin syndrome. Serotonin syndrome occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea.²³

June − The TGA in a Medicines Safety Update warned that microscopic colitis (a type of inflammatory bowel disease) is a potential adverse effect of the antidepressant sertraline ( Zoloft and other brands). It is characterised by non-bloody watery diarrhoea. Diarrhoea is a very common adverse reaction and occurs in at least 10% of people who start taking sertraline. If diarrhoea is severe or prolonged, microscopic colitis should be taken into consideration. This side effect has been added to the Product Information.²⁴

2018

June – The TGA issued a Medicines Safety Update to warn and remind health professionals to effectively communicate to patients and carers the risk of neuropsychiatric side effects (including agitation, aggressive behaviour or hostility, depression, insomnia, irritability, hallucinations, suicidal thinking and behaviour) with antidepressants, atomoxetine (Strattera, an ADHD drug and antidepressant) and the antidepressant Zyban used in smoking cessation. Suicidal thinking and behaviour are of serious concern to consumers and generate complaints to the TGA, the warning said. One survey found that just over half of the inpatients and one third of community-based patients reported they did not receive any medicines information. Health professionals are strongly encouraged to provide patients with information on these drugs. The importance of educating patients and their carers about not suddenly stopping these psychiatric drugs due to withdrawal syndrome (worsening of existing symptoms or new not before experienced symptoms) was covered again in this warning.²⁵

June – A second drug warning was issued in June for the antipsychotic clozapine to warn that clozapine has also been associated with potentially fatal risk of intestinal obstruction, faecal impaction and paralytic ileus (obstruction of the intestine due to paralysis of intestinal muscles). Bowel function and constipation should be closely monitored.²⁶

February – The TGA warned that the maximum dose for desvenlafaxine (Pristiq, an antidepressant) should not be exceeded as prescribing above it can increase side effects.²⁷

2017

October – The TGA warned in a Medicines Safety Update that lithium toxicity (Quilonum and Lithicarb, antipsychotics) can occur close to usual dose. Regular and clinical monitoring is necessary and failure to recognise early signs of toxicity can result in death. As of May 2017, the TGA had received 58 reports linked to lithium toxicity, 2 resulted in death. Early signs include: agitation, nausea/vomiting, muscle weakness, diarrhoea, hand tremors, drowsiness. Neurological manifestations and cognitive impairment from lithium toxicity may not be fully reversible.²⁸

February – The TGA advised in a Medicines Safety Update that the antipsychotic aripiprazole (Abilify and other brands) can cause increased urges particularly for gambling along with the inability to control these urges. Other urges reported included increased sexual urges, compulsive spending and eating and these urges in some cases ceased when the drug was reduced or discontinued.²⁹

2016

December – The TGA issued another Medicines Safety Update covering the increased risk of suicidal thinking and behaviour with antidepressants, particular SSRI’s (a class of antidepressants). The TGA stated that several studies have shown that patients and carers have not received enough information about their drugs and the TGA strongly encourages doctors to give their patients the relevant CMI for the antidepressant prescribed. They also warned that antidepressants should never be suddenly stopped and should be reduced gradually [always under a doctor’s supervision] to avoid potential discontinuation symptoms (also called withdrawal syndrome– worsening of current symptoms or new never before experienced symptoms) such as nausea, sleep problems, dizziness, irritability, anxiety, numbness and ‘electric shock-like’ sensations.³⁰

2015

August – The TGA in a Medicines Safety Update advised that they had received 17 reports of cerebrovascular adverse reactions (stroke) for the antipsychotic risperidone (Risperdal). As far as dementia in the elderly is concerned, risperidone is now limited to treatment up to 12 weeks for moderate to severe Alzheimer dementia only. The new Product Information used by doctors to prescribe for risperidone also states that non-drug approaches should be used first.³¹

April – The TGA issued a Medicines Safety Update to warn of the risk of liver injury with the use of the antidepressant agomelatine (Valdoxan). The Product Information for agomelatine has been updated to state that it is recommended that liver function tests are done prior to prescribing and before increasing the dose. The TGA also advised that there should be close surveillance of liver function, including liver tests.³²

2014

October – A TGA’s Medicine Safety Update advised that in rare cases methylphenidate (Ritalin and Concerta- ADHD drugs) may lead to prolonged and sometimes painful erections. A precaution for this has been added to the Product Information. The TGA also stated that the Product Information for atomoxetine (Strattera– ADHD drug) lists painful or prolonged erection as a potential side effect.³³

October – The TGA issued a Medicine Safety Update to warn of serious cardiovascular adverse events with the antidepressant bupropion (Zyban) used in smoking cessation.³⁴

September – The TGA in a Safety Alert warned doctors to be alert for serotonin syndrome in people taking drugs used to treat nausea and vomiting who are also on antidepressants (serotonin syndrome occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea). In some cases, the TGA said serotonin syndrome can lead to a loss of consciousness, coma and death. The TGA said doctors should advise patients and caregivers of the risk or serotonin syndrome.³⁵

August – The TGA completed a safety review of the sleeping drug zolpidem (Stilnox). Subsequently the TGA recommended specific dose rates and warned of next day impairment including drowsiness. They also warned again of potentially dangerous side effects such as sleep-walking, sleep driving and other bizarre behaviour related to zolpidem.³⁶

February – The TGA issued a Medicines Safety Update regarding the antipsychotic quetiapine (Seroquel and its generics) because post marketing reports indicated that it can cause QT prolongation (a QT interval is part of the cycle of a heartbeat. A prolongation of the QT interval increases the risk of sudden death from abnormal heartbeats). This has occurred not only with overdoses but also with concomitant illness (naturally accompanying or associated illness) and in patients taking other drugs known to cause electrolyte imbalances or increase the QT interval. A new warning in the Product Information (PI) advises that quetiapine treatment in combination with antipsychotics and other drugs known to increase the QT prolongation be avoided, particularly in the elderly. The TGA has received 807 adverse event reports for quetiapine including 2 reports of cardiac arrest.³⁷

February – The benzodiazepine Alprazolam (Xanax and its generics) was made a Schedule 8 drug placing it in the same category as cocaine, morphine and opium. A Schedule 8 drug is a “controlled drug” meaning its use is restricted to reduce abuse, misuse and physical or psychological dependence.³⁸

2013

December – A Medicines Safety Update issued by the TGA for the antidepressant duloxetine (Cymbalta and generics) to warn it can cause serotonin syndrome (serotonin syndrome occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea). The TGA has received 21 reports of serotonin syndrome in which duloxetine was the sole suspected drug.³⁹

October – The TGA issued a Medicine Safety Update concerning the risk of suicidality in children with the non-stimulant ADHD drug atomoxetine (Strattera, an antidepressant) after the suicide of a 9 year old on the drug. The TGA has received 65 adverse event reports for psychiatric disorders associated with atomoxetine, 45 of these were reports of suicidal ideation with 28 of these for children younger than 18. There were 2 other reports for attempted suicide in children. The TGA advised that anyone prescribed atomoxetine should be monitored for suicidality.⁴⁰

October – The ADHD drug lisdexamfetamine (Vyvanse) had a “boxed warning” placed on it to warn that is has the potential for abuse, misuse, dependence or diversion. The boxed warning also states that anyone prescribed the drug should be monitored for abuse and dependency.⁴¹

2012

June – A Medicines Safety Update issued by the TGA states that they continue to receive reports of potentially dangerous, complex sleep-related behaviours, amnesia and hallucinations associated with the sleeping tablet zolpidem (Stilnox) use. In 2007, a boxed warning was placed on the drug to warn of bizarre behaviours and despite the media and publicity surrounding this drug, adverse events have persisted at high levels. The Medicines Safety Update instructs that patients should be told of the risks and health professionals are encouraged to report adverse reactions to the TGA.⁴²

February – The TGA issued a Medicine Safety Update concerning the risk of clinically significant increases in blood pressure and/or heart rate with the use of the non-stimulant ADHD drug Strattera (atomoxetine, an antidepressant). This issue of the Medicine Safety Advisory also warned again the antidepressant citalopram should no longer be used in doses above 40mg as it may be life threatening in higher doses. These follow on from the earlier safety advisories issued in November 2011.⁴³

2011

November – The TGA advised that the antidepressant citalopram (Cipramil, Celapram, Talum, Ciazil, Citalobell, Celica and others with “citalopram” in their name) should no longer be used in doses above 40mg, for some patients no more than 20mg and others with a specific congenital heart condition should not take citalopram. Higher doses may result in life-threatening or fatal arrhythmias in some people. Stopping citalopram suddenly can cause withdrawal symptoms including anxiety, insomnia, emotional instability, headache, diarrhoea, vomiting and palpitations.⁴⁴

November – The TGA issued a Safety Advisory regarding the risk of increased blood pressure and/or heart rate with the use of the non-stimulant ADHD drug atomoxetine (also known as Strattera, an antidepressant). Heart rate and blood pressure should be measured before treatment and monitored during treatment.⁴⁵

October – The TGA issued a Medicines Safety Update to inform that the stimulant Modafinil (Modavigil) has had several safety changes and recommendations to the PI as a result of a TGA benefit-risk review after reports of serious skin, psychiatric, nervous system and cardiovascular adverse reports. These changes to the PI include warning that Modafinil has been associated with aggressive and hostile behaviour, suicidal ideation, suicidal-related behaviour, psychosis, mania, depression and ischaemic (reduced blood supply) heart disease in patients with a history of cardiovascular disease.⁴⁶

August – The TGA in their Medicines Safety Update said that stress cardiomyopathy (deterioration of the heart muscle) may be an adverse effect of venlafaxine (antidepressant also known as Efexor).⁴⁷

August – The TGA issued a Medicines Safety Update to warn that new born infants exposed to antipsychotics during the third trimester of pregnancy may be at risk of extrapyramidal signs (involuntary movements and muscle rigidity) and/or withdrawal syndrome. Adverse side effects reported to the TGA for newborns include: breathing difficulties, tremor, agitation and muscle rigidity. All antipsychotics are now classed as pregnancy category C drugs. This means they are in the third most dangerous drug category and suspected of causing harmful effects on the foetus or newborn without causing malformation. These effects may be irreversible. All Product Information for antipsychotics is being updated to include this information.⁴⁸

April – The TGA in their Medicines Safety Update Bulletin said that antidepressants appear commonly in suspected reports for drug-induced hyponatraemia (a lower-than-normal level of sodium in the blood which if severe can cause significant and permanent neurological injury or death). Commonly reported symptoms of hyponatraemia included confusion, dizziness, dehydration, nausea and vomiting.⁴⁹

February – The TGA issued in their Medicines Safety Update a warning that if left untreated clozapine (an antipsychotic) induced constipation can lead to serious, potentially fatal complications. Health professionals should inform patients about the risk of constipation with clozapine.⁵⁰

February – The TGA in their Medicines Safety Update warned of a potential higher death rate amongst women who take tamoxifen for breast cancer and who also use paroxetine (antidepressant). It stated caution should also be taken with other SSRIs (a class of antidepressants).⁵¹

2010

December – The TGA in their Medicines Safety Update issued a warning for drug-induced acute akathisia (the inability to remain motionless) particularly in patients taking antipsychotics. The inner restlessness and drive to move can result in significant distress.⁵²

December – The TGA issued in their Medicines Safety Update a ‘reminder’ on serotonin syndrome (serotonin syndrome occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea) to warn that certain drugs including lithium, SSRIs, MAOIs (SSRIs and MOIs are class of antidepressants) tricyclic antidepressants and SNRIs (a class of antidepressants including Efexor and Cymbalta) can cause serotonin syndrome. Early signs and symptoms can be mild, yet life-threatening. Symptoms include: altered mental states – confusion, agitation, restlessness and excitement, as well as physical manifestations such as shivering, flushing, tachycardia (increased heart rate) and hyperthermia (elevated body temperature). Refer also to October 2009 entry above.⁵³

April – The TGA warned in their Medicines Safety Update that atypical antipsychotics (released after 1998 such as clozapine, risperidone and olanzapine) are one of the commonly implicated classes of drugs causing drug-induced pancreatitis.⁵⁴

2009

December – The TGA released the final report of an independent Psychiatric Drug Safety Expert Advisory Panel established in 2008 by the TGA to undertake a scientific review of a series of cases submitted to the TGA by a psychiatrist and an extensive literature review of SSRIs and antipsychotics. Their recommendations included:

• The Product Information (PI) for reboxetine (antidepressant) should include advice about the potential for neonatal side effects.

• The PI for all SSRIs should warn of the risk of Persistent Pulmonary Hypertension (high blood pressure in the lungs) for newborns.

• Consideration should be given to requiring all PI documents for atypical antipsychotics to recommend glycemic monitoring regimes (used to monitor blood sugar levels) for those at risk of or those with diabetes. Atypical antipsychotics are known as second generation antipsychotics which were largely introduced after the 1970s.

• That the TGA should review consistency and appropriateness of advice in the PI of all SSRIs concerning monitoring patients at risk of diabetes or with diabetes.

• Consideration should be given to requiring PI documents of SSRIs and SNRIs (a class of antidepressants including Efexor and Cymbalta) to warn of serotonin syndrome during treatment (serotonin syndrome occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea) during treatment. Treatment with the drug should be discontinued if symptoms of serotonin syndrome occur. 

• Consideration should be given that the PI Documents of all SSRIs and SNRIs warn that they should not be used in combination with monoamine oxidase inhibitors (MOIA – a class of antidepressant drug which includes moclobemide). Cases of potentially life-threatening serotonin syndrome have been reported in those on both drugs or those who have recently discontinued an SSRI/SNRI and started on a MAOI.

• They also recommended: There should be a standardized way in which important “drug to drug interaction” information is presented in the PI; The TGA should implement a program where Australian PIs are regularly reviewed for consistency with other international documents throughout the life of the PI for these drugs; The TGA should include items on serotonin syndrome in their upcoming issues of Adverse Drug Reaction Bulletins.⁵⁵

October – The TGA issued an Adverse Drug Reactions Bulletin to warn that antidepressants have properties that predispose individuals to suffer adverse effects when switching antidepressants. Serotonin syndrome, a potentially life-threatening condition, which occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea symptoms can occur during treatment and during switching particularly in the elderly.⁵⁶

August – The TGA issued an Adverse Drug Reactions Bulletin to warn that the antidepressant duloxetine, also know as Cymbalta can cause serotonin syndrome (which occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea.) The TGA said they have had 108 reports of suspected adverse reactions for duloxetine from June 2008 to May 2009 including 10 cases of suicidal ideation and 8 cases of agitation. From the evidence the TGA has, they say that serotonin syndrome can occur with duloxetine treatment alone even at normal doses as well as in combination with other drugs known to cause this syndrome. The Product Information for Cymbalta has been updated to include this information.⁵⁷

February – A Boxed Warning (the strongest warning) was placed onto the ADHD drug Concerta by the TGA for drug dependence. It warns that chronic abuse of Concerta can lead to a marked tolerance and psychological dependence with varying degrees of abnormal behaviour and frank psychotic episodes can also occur.⁵⁸

2008

December – The TGA issued an Adverse Drug Reactions Bulletin to warn that the stimulant-like drug, modafinil, can cause serious life-threatening skin reactions and serious psychiatric reactions. The TGA recommends that at the first sign of rash or if patient experiences psychiatric symptoms, modafinil should be discontinued and not restarted.⁵⁹

October – The TGA reported in their Adverse Drug Reactions Bulletin that they had received 307 reports of hyponatraemia since May 2005. (Hyponatraemia a lower-than-normal level of sodium in the blood which if severe can cause significant and permanent neurological injury or death). Antidepressants were the suspected cause in 78 of these reports. 101 of the total reports were severe and the most commonly associated drugs for severe hyponatraemia included carbamazepine (anticonvulsant) and the antidepressants, paroxetine (Aropax), venlafaxine (Efexor) and sertraline (Zoloft).⁶⁰

February – The TGA imposed a Boxed Warning on the sleeping table Stilnox (zolpidem) after 1032 reports of adverse reactions to the drug. The Boxed Warning explains that the drug may be associated with potentially dangerous complex sleep related behaviours including sleep walking, sleep driving and other bizarre behaviours. Close medical supervision is needed.⁶¹

2007

August – The TGA issued an Adverse Drug Reactions Bulletin about newer antipsychotic agents causing extrapyramidal side-effects – EPS (involuntary movements and muscle rigidity). There had been 70 reports for clozapine and 126 reports for olanzapine (Zyprexa). About one third of patients experiencing EPS had not recovered.⁶²

August – The TGA’s drug adverse reaction database revealed there had been 112 notified adverse reactions reports—in 67 separate cases—for antidepressant use among under 10-year-olds.  These included convulsions, mania, muscle spasms, hallucinations and insomnia.  A further 807 adverse health responses, in 495 cases, had been linked to use by youths aged between 10 and 19 years.  The reactions for 10- to 19-year-olds include 4 deaths.⁶³

June – The TGA issued an Adverse Drug Reactions Bulletin stating that a range of cardiac disorders are associated with the use of the antipsychotic drug clozapine. A Boxed Warning alerting prescribers is on the product information. Prescribers should be warned that potentially fatal myocarditis (inflammation of the heart muscle) may develop after commencement of Clozapine.⁶⁴

June – The TGA issued an Adverse drug Reactions Bulletin for the antidepressant Mirtazapine (Avanza) stating prescribers need to warn patients of potentially life-threatening neutropenia (condition where a type of white blood cells is low) and agranulocytosis failure of bone marrow to make enough white blood cells).⁶⁵

April –The TGA issued an Adverse Drug Reactions Bulletin stating that it appears that all of the atypical antipsychotics can cause neuroleptic malignant syndrome – NMS (abnormally high body temperature causing destruction of tissue which can be potentially fatal). They said they have received 85 reports of NMS for clozapine, 49 reports for olanzapine (Zyprexa), 45 reports for risperidone and there were another 46 reports for other antipsychotics.⁶⁶

April 5 – The Australian Therapeutic Goods Administration requested that the makers of the sleeping drug Stilnox (zolpidem) strengthen the current warning about mixing the medicine with alcohol. This request comes in the wake of more than 500 complaints about Stilnox including reports of sleepwalkers crashing cars, falling off balconies, smoking, painting and having sex after popping a pill.⁶⁷

February – The Australian Therapeutic Goods Administration warned that zolpidem (Stilnox) has had a number of side effect reported, of which “75% of the reports received described one or ore neurological or psychiatric reactions, especially visual hallucinations, confusion, depression and amnesia.” The Advisory Committee is recommending that people need to be alert to these possible side-effects, and doctors need to warn their patients about it.⁶⁸

2006

October 18 – The TGA ordered manufacturers of “ADHD” drugs, Ritalin, Strattera and dexamphetamine to add stronger warnings to their information packaging after receiving 200 adverse reaction reports about the drugs. The TGA had received 123 reports of adverse reactions involving Ritalin, including complaints that it caused headache, nausea, anorexia, somnolence and depression as well as 23 reports about atomoxetine (Strattera), including aggression, and 60 reports about dexamphetamine, including seven of agitation, five of tachycardia (rapid heartbeat) and four reports each of hypertonia (abnormally increased muscle tone causing rigidity), hyperkinesia (involuntary movements occurring continuously) and insomnia.⁶⁹

March 14th – The TGA ordered a boxed warning (the most serious type of warning) for the risk of suicidal thoughts and behaviours be put onto Strattera, a non-stimulant drug prescribed for ADHD.⁷⁰

2005

December – The TGA issued an Adverse Drug Reactions Bulletin stating that the antipsychotics risperidone, fluphenazine, haloperidol, clozapine, olanzapine, pimozide and thioridazine and the antidepressants amitriptyline, imipramine, clomipramine, dothiepin and doxepin can cause a QT prolongation effect. A QT interval is part of the cycle of a heart beat. A prolongation of the QT interval increases the risk of sudden death from abnormal heart beats and in this case the TGA said it can lead to a life-threatening tachycardia (increased heart rate).⁷¹

September 7 – The TGA issued an information sheet to health professionals warning that SSRI use—especially Paxil—in early pregnancy could cause congenital heart abnormalities in newborns. It reported that Danish researchers had determined the association in the first trimester of pregnancy. It recommended that patients not suddenly stop taking Paxil because “they may have withdrawal effects that can be severe or life-threatening. Dosage must be tapered off….”⁷²

August – The TGA published an Adverse Drug Reactions Bulletin reporting a review of SSRIs found evidence supporting an association between SSRI use and “new onset of suicidality” (the likelihood of an individual completing suicide) in adults. It usually developed shortly after commencing the drugs or after an increase in dosage that could cause akathisia, (the inability to remain motionless) agitation, nervousness and anxiety. Similar symptoms could also occur during withdrawal.⁷³

2004

December – The TGA published an Adverse Drug Reactions Bulletin recommending that any use of SSRIs in children and adolescents should be carefully monitored for the emergence of suicidal ideation. In a recent study involving Prozac, it said, there was an increase in adverse psychiatric events (acts and ideation [thoughts] of suicide, self-harm, aggression, violence).⁷⁴

October – The TGA ordered a new warning be added to the Product Information for tricyclic antidepressants to warn of the risk of suicide by overdose after high dose presentations that can be obtained by patients have been associated with some patient deaths from overdose.⁷⁵

June – The TGA published an Adverse Drug Reactions Bulletin reporting that the latest antipsychotics could increase the risk of diabetes.⁷⁶

February – The TGA reported they had received 161 reports of serotonin syndrome. Serotonin syndrome occurs when the body has too much serotonin; symptoms may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhoea. It is potentially serious. SSRIs, venlafaxine (Efexor) and tricyclic antidepressants can cause this syndrome. In the majority of reports, the signs and symptoms developed within 24 hours of the addition of another serotonergic agent or an increase in dose of an agent. The TGA said health professionals should note that they can cause this and should inform patients of the risk when seretonergic agents are prescribed.⁷⁷

2003

October – The TGA reported that new antidepressants Remeron, Avanza and Mirtazon could cause potential serious reactions such as convulsions, blood clots, anxiety, agitation, blood disorders, nightmares, and hallucinations.⁷⁸

August – The TGA reported that the use of SSRIs during or after pregnancy may result in adverse reactions to newborn babies, due to the withdrawal effect following intra-uterine exposure, or a toxic effect from ingestion of an SSRI in breast-milk. Withdrawal effects reported for babies included agitation, jitteriness, poor feeding, gastrointestinal symptoms and hypotonia (deficient muscle tone or tension).⁷⁹

June – The TGA reported that as a group, SSRIs account for about one-quarter of all reports of hyponatremia (a lower-than-normal level of sodium in the blood) received by the Australian Drug Reactions Advisory Committee, and are second to diuretics as the group most commonly associated with hyponatraemia. In about two-thirds of cases, full recovery followed withdrawal of the SSRI and fluid restriction. Three cases had a fatal outcome related to hyponatraemia.⁸⁰

2001

February – The TGA reported that SSRIs have an association with raised internal pressure within the eye.⁸¹

2000

February – The TGA published an Adverse Drug Reactions Bulletin reporting that psychiatric drugs can cause nightmares and specifically mentioned Prozac, Zoloft, Paxil and Celexa.⁸²

1999

December – The TGA reported that SSRIs and tricycle antidepressants can cause constipation. 15 reports have also been received for the antipsychotic clozapine and of these 9 were described as severe.⁸³

August – The TGA issued an Adverse Drug Reactions Bulletin to warn that olanzapine (Zyprexa) can cause serious problems such as white cell disorders, convulsions and neuroleptic malignant syndrome (abnormally high body temperature causing destruction of tissue). They also said that weight gain and somnolence (excessive sleepiness) were the most commonly reported side-effects. To date they had received 327 suspected adverse reactions to the drug.⁸⁴

1998

August – The TGA issued an Adverse Drug Reactions Bulletin on SSRIs such as fluoxetine (Erocap, Lovan, Prozac, Zactin), paroxetine (Aropax) and sertraline (Zoloft) stating they have been associated with bruising and bleeding.⁸⁵

February – The TGA issued an Adverse Drug Reactions Bulletin reporting that venlafaxine (Efexor), an antidepressant drug appears to have a greater association with nausea/vomiting/anorexia, headache, increased sweating, syncope (fainting caused by a cardiovascular disorder) and hypertension than the SSRIs.⁸⁶

1997

November – The TGA issued an Adverse Drug Reactions Bulletin concerning neonates whose mothers had taken SSRIs throughout their pregnancies and have experienced withdrawal reactions. Reports included a 3 day old baby who developed jitteriness, fever and anorexia. Another baby was treated for rapid breathing and irritability for 2 days after it was born. These reports suggest that adverse reactions to SSRIs can occur in neonates, through either placental or breast milk transfer.⁸⁷

1996

August – The TGA issued an Adverse Drug Reactions Bulletin on adverse effects of SSRIs. They said the selective serotonin reuptake inhibitors (SSRIs), fluoxetine (Lovan, Prozac, Zactin), paroxetine (Aropax) and sertraline (Zoloft) are associated with a variety of adverse effects. They found that 2 of the unusual types of adverse effects were urinary problems and sexual dysfunction.⁸⁸

February – The TGA issued an Adverse Drug Reactions Bulletin stating SSRIs have been associated with withdrawal syndrome. The symptoms most commonly reported on withdrawal were dizziness (15 reports) and nausea (10). Anxiety, headache (both 5 reports), agitation, insomnia, increased sweating, tremor and vertigo (4 of each), hallucinations, and depersonalisation (3 of each) were also described. There was a total of 51 different symptoms documented in the reports with a wide range of other neurological and psychiatric symptoms including amnesia, ataxia (unstable gait), blurred vision, confusion, dysarthria (dis-coordination of the speech muscles), delirium, fatigue, hyperacusis (abnormally acute hearing), hypertonia (abnormally increased muscle tone causing rigidity), meningism (spasms of the neck muscles caused by inflammation of the membranes around the brain and spinal cord), mood swings, neurosis, nervousness, nightmares, paraesthesia (abnormal skin sensation eg burning sensation in the skin), rigors, sensory disturbance, tinnitus (ringing in the ears), and twitching. There was also a report of a neonatal withdrawal reaction.⁸⁹

1995

November – The Australian Therapeutic Goods Administration (TGA) issued an Adverse Drug Reactions Bulletin stating that they had received 109 reports of drug- induced pancreatitis and the most commonly reported drugs in association with this included the antipsychotic clozapine and yet this was not at the time listed as a possibility in the Product Information for the drug.⁹⁰

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