What is tafenoquine?
Tafenoquine is an anti-malarial medication that is related closely to primaquine. In clinical studies it has been shown to successfully prevent and treat malaria infections, especially those infections that recur after leaving a malarious area (relapsing malaria).
Is tafenoquine related to mefloquine?
No, tafenoquine is not related to mefloquine and acts quite differently in the body. Tafenoquine is closely related to primaquine, which has been used for malaria prevention in the ADF for many years. The names sound similar because most medications used against malaria end in “quine” but otherwise they are completely different compounds.
How many people in the ADF have taken tafenoquine?
Altogether, 1540 ADF members have taken tafenoquine: 1017 in the tafenoquine eradication trials in Bougainville and East Timor in 1999/2000; 31 in a malaria treatment trial in 2000/2001; and 492 in the tafenoquine prophylaxis trial in East Timor in 2000/2001.
What are the side effects of tafenoquine?
Common side effects include headache and gastrointestinal upset (nausea, vomiting, diarrhoea). Corneal deposits (vortex keratopathy) have been reported in ADF personnel taking tafenoquine for six months for malaria prophylaxis. These deposits did not interfere with vision and went away after the medication was stopped. In studies where participants took only a single dose of tafenoquine, no eye effects have been noted. Other medicines may also cause this condition.
People who don’t have the G6PD enzyme should not take tafenoquine, because, like primaquine, it can cause red blood cell problems and anaemia in these people. All ADF personnel are tested for this enzyme on entry.
Does tafenoquine have serious neuropsychiatric effects?
Tafenoquine is not known to cause serious neuropsychiatric side effects. To date more than 4000 people, both military and civilian, have taken tafenoquine in clinical studies around the world and none of those studies have produced any evidence that it causes serious neuropsychiatric effects in people without pre-existing psychiatric or psychotic disorders.
The most common side effects reported have been gastro-intestinal; nausea, vomiting, abdominal cramps and diarrhoea. The ADF trials conducted in 2000-2001 also saw instances of a benign eye condition (corneal vortex keratopathy). All of these conditions resolved after the medication was discontinued.
Does tafenoquine cause blindness?
No, tafenoquine does not cause blindness. The ADF trial of tafenoquine in East Timor in 2000/2001 included a sub-group that had comprehensive eye examinations by an ophthalmologist pre and post deployment. In this group it was identified that long term use of tafenoquine was associated with the development of fine deposits on the surface of the eye (corneal vortex keratopathy) in some people. These deposits did not affect the recipient’s vision and fully resolved within 12 months of ceasing the medication.
The detailed examinations by ophthalmologists did not identify any other significant abnormalities. No trial participants suffered blindness or a significant loss of vision from tafenoquine.
Why did the ADF test tafenoquine in its personnel?
Malaria is a deadly disease and a threat to ADF personnel. Most of our recent deployments have been to malarious areas in the Asia-Pacific region and the Middle East. Over time, anti-malarial medications lose their effectiveness as the malaria parasites become resistant to them. New medications need to be developed to ensure the ADF has effective protection against malaria.
Does the ADF conduct drug trials ethically?
Approval from a human research ethics committee is required before any clinical trial of a drug can begin. The Army Malaria Institute* (AMI) conducted the anti-malarial drug trials in accordance with national guidelines issued by the National Health and Medical Research Council (NHMRC) and the Therapeutic Goods Administration (TGA), with the study protocols approved by the Australian Defence Human Research Ethics Committee (ADHREC).
ADHREC was a properly constituted human research ethics committee registered with the NHMRC. It was replaced by the joint Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC) on 1 July 2017. More information about DDVA HREC is available from the DDVA HREC website. Information about ADHREC is available from the Joiny Health Command Health Research Coordination website.
Were ADF members forced to participate in clinical trial of tafenoquine?
Participation in the clinical trials involving tafenoquine was voluntary. ADF members were provided with comprehensive information packs, were fully briefed and given the opportunity to ask questions. A point of emphasis was that whatever their decision, whether to participate or not, there would be no negative impact on them, there would be no detriment to them. That means, if they chose not to participate, there would be no negative consequences to their career or future health care.
Once fully informed, those who wanted to participate in the studies signed a consent form. The participants were also made aware that they could withdraw from the study at any time without detriment.
Some ADF members chose not to participate in the study. These members still needed to take an anti-malarial medication for their protection during the deployment in accordance with extant health policy.
Defence is aware of allegations from some personnel who feel that their participation was not voluntary. These allegations were investigated by the Inspector General of the Australian Defence Force (IGADF). The IGADF report is available here.
Is tafenoquine registered for use in Australia?
Yes. The Australian Therapeutic Goods Administration (TGA) approved the registration of tafenoquine on 13 September 2018. It is available for both malaria prevention (under trade name Kodatef™) and radical cure (under the trade name Kozenis™).
Can former ADF members involved in the trials request and access their medical records from the Department of Defence?
Serving and former ADF members who participated in the anti-malarial trials can access both their case records from the trial and their Defence health records.
Participants seeking their trial case records can make a request in writing to Joint Health Command at ADF.Malaria@defence.gov.au. They will need to provide their full name, date of birth, service/PMKEYS number and contact details (telephone, email and postal address). It may take several weeks to provide the documents as they have to be located and retrieved from the AMI* archives and checked for completeness. These documents will be released by the Commander Joint Health.
Serving ADF members who want to access their health records can make a request through their supporting Defence Health Centre.
Ex-serving members who want to access their personnel and health records need to submit a request to the Defence Archives Centre on ADF.Records@defence.gov.au. More information is available from Defence Service Records site.
Can the Department of Defence confirm that the medical records of those involved in drug trials conducted by the ADF will not be deleted?
Health records of ADF members are managed in accordance with the Archives Act 1983 and Defence records management policy. Health records of ADF members are retained for at least 100 years after their date of birth. Case records for trial participants are held at AMI and will not be destroyed. Records related to significant medical research activities conducted in the ADF are retained permanently.
Did ADF members involved in AMI trials receive any follow-up?
ADF members who participated in the trials were specifically monitored in accordance with the applicable trial protocol, as approved by the ethics committee.
In addition to the examinations required by the approved protocols, ADF members had post deployment medical and mental health examinations prior to return to Australian and again three to six months after deployment. These examinations are designed to identify any significant health conditions.
Further to this, all ADF members receive periodic health assessments throughout their service. These were conducted annually until 2010 and since then all members receive a comprehensive health assessment every two to five years (depending on age) and before they separate from the ADF. More information on health monitoring in the ADF is available here
Where can I get more information about tafenoquine?
Recent publications regarding tafenoquine are available in the additional resources section of this website.
Consumer Medicines Information (CMI) and Product Information (PI) for tafenoquine can be found on the TGA website.
* In 2017 the Army Malaria Institute was renamed the Australian Defence Force Malaria and Infectious Diseases Institute