Missing 2004 IL10-2004-007 Recovered — Details Long-Term Health Effects from Malarial Mefloquine Drug — Also Roche Report from Australia Lists Disabling Toxic Effects.
Ellen Duncan, wife of Maj. General Alastar Duncan in Britain, has sent me these documents but I don’t know how to attach them to this blog. Mrs. Duncan has started her own blog describing how she and her husband are fighting to have the general’s blast injury to his brain and mefloquine toxicity recognized, but British Health Officials continue to label his condition as dementia despite rising evidence. I recommend that you all read her blog that follows. BONNIE
A WARRIOR’S STORY
A soldier’s struggle with neuro-toxic brain injury.
From ROCHE REPORT, AUSTRALIA — I‘m sorry but the table formatting was lost in copying this excerpt. If you email me at email@example.com I will attach both documents for you to read. Bonnie
Mefloquine is an odourless, bitter-tasting, white crystalline powder. It is soluble in methanol and ethanol but practically insoluble in water. A 1% aqueous suspension has a pH of 5.6.
LARIAM tablets are cylindrical biplanar, white to off-white, cross-scored with break bars on both faces and marked with “RO”, “C”, “HE” and an imprinted hexagon in the quadrants of one face. They contain 250 mg mefloquine in the form of mefloquine hydrochloride (274.09 mg). LARIAM tablets also contain the following excipients: poloxamer 3800, microcrystalline cellulose, lactose, maize starch, crospovidone, ammonium calcium alginate, talc and magnesium stearate.
LARIAM (mefloquine) is an antimalarial belonging to the quinoline-methanol group of medicines and is structurally related to quinine.
Table 2 Adverse Events Attributed to the Study Drug# Lariam (n = 483)
atovaquone-proguanil (n = 493)
Any adverse event
Any neuropsychiatric event
Strange or vivid dreams
Dizziness or vertigo
Any gastrointestinal event
#Mean duration of treatment ± SD was 28 ± 8 days for atovaquone-proguanil and 53 ± 16 days for Lariam.
In the table below, an overview of adverse reactions is presented, based on post marketing data.
Adverse reactions are listed according to MedDRA system organ class and frequency category. Frequency categories are defined using the following convention:
very common (>1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data).
Blood and lymphatic system disorders
Agranulocytosis, aplastic anaemia, leukopenia, leukocytosis, thrombocytopenia
Metabolism and nutrition disorders
Abnormal dreams, insomnia
Agitation, restlessness, mood swings, panic attacks, confusional state, hallucinations, aggression, bipolar disorder, psychotic disorder including delusional disorder, depersonalisation and mania, paranoia, suicidal ideation
Nervous system disorders
Balance disorder, somnolence, syncope, convulsions, memory impairment, peripheral sensory neuropathy and peripheral motor neuropathy (including
Lariam PI 141107 13
Due to the long half-life of LARIAM, adverse reactions to LARIAM may occur or persist up to several weeks after the last dose. In a small number of patients it has been reported that dizziness or vertigo and loss of balance may continue for months after discontinuation of the medicine. There have been rare reports of suicidal ideations. No relationship to drug administration has been established.
DOSAGE AND ADMINISTRATION
Adults and children of more than 45 kg bodyweight:
(i) Non-immune patients recently arrived from endemic areas.
The recommended total dosage of LARIAM, 1250 mg according to bodyweight, should be administered as follows:
A loading dose of 3 tablets (750 mg), followed 6 to 8 hours later by 2 tablets (500 mg).
Paraesthesia, tremor and ataxia), encephalopathy
Vision blurred, cataract, retinal disorders and optic neuropathy which may occur with latency during or after treatment
Ear and labyrinth disorders
Vestibular disorders (long term) including tinnitus and hearing impaired
Chest pain, Tachycardia, palpitation, bradycardia, irregular heart rate, extrasystoles, other transient conduction disorder, AV block
Cardiovascular disorders (hypotension, hypertension, flushing)
Respiratory, thoracic and mediastinal disorders
Dyspnoea, pneumonitis of possible allergic etiology
Nausea, diarrhoea, abdominal pain, vomiting
Drug-related hepatic disorders from asymptomatic transient transaminase increase to hepatic failure
Skin and subcutaneous tissue disorders
Rash, erythema, urticaria, alopecia, hyperhidrosis, erythema multiforme, Stevens-Johnson syndrome
Musculoskeletal and connective tissue disorders
Muscular weakness, muscle spasms, myalgia, arthralgia
General disorders and administration site disorders
Oedema, asthenia, malaise, fatigue, chills, pyrexia, hyperhidrosis
Lariam PI 141107 14
ii) Semi-immune patients
For patients in malaria endemic areas, a smaller total dosage of LARIAM – 750 to 1,000 mg – is sufficient since they have usually developed partial immunity. Adults weighing 60 kg receive an initial dose of 3 tablets, followed by 1 tablet 6 to 8 hours later.
If a full treatment course has been administered without clinical cure, alternative treatments should be given. Similarly if previous prophylaxis with LARIAM has failed, LARIAM should not be used for curative treatment.
Prophylaxis of malaria with LARIAM should be initiated 1 week before arrival in a malarious area.
The following dosage schedule is given as a guide:
LARIAM can be used for up to 3 months in the prophylaxis of malaria.
Course of Prophylaxis
Adults and children of more than 45kg bodyweight
Stated dose to be given once weekly, always on the same day. First dose one week before departure. Further doses at weekly intervals during travel in malarious areas and for 2 weeks after leaving the area.
The tablets should be swallowed whole with plenty of liquid.
LARIAM can be given for severe acute malaria after an initial course of intravenous quinine lasting at least 2 – 3 days. Interactions leading to adverse events can largely be prevented by allowing an interval of at least 12 hours after the last dose of quinine.
In cases of overdosage with LARIAM, the symptoms mentioned under ADVERSE EFFECTS may be more pronounced.
Patients should be managed by symptomatic and supportive care following LARIAM overdose. There are no specific antidotes. Monitor cardiac function (if possible by ECG) and neuropsychiatric status for at least 24 hours. Provide symptomatic and intensive supportive treatment as required, particularly for cardiovascular disturbances.
Contact the Poisons Information Centre on 13 11 26 for advice on management of overdosage.
Lariam PI 141107 15
PRESENTATION AND STORAGE CONDITIONS
Packs of 8 tablets (cross-scored) each containing 250 mg mefloquine.
Store below 30 °C. Store in original container. Protect from moisture.
Disposal of Medicines
The release of medicines into the environment should be minimised. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Unused or expired medicine should be returned to a pharmacy for disposal.
NAME AND ADDRESS OF THE SPONSOR
Roche Products Pty Ltd
ABN 70 000 132 865
4-10 Inman Road
Dee Why NSW 2099
Customer enquiries: 1-800-233-950
POISONS SCHEDULE OF THE MEDICINE
Schedule 4 – Prescription Only Medicine
DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (ARTG):
27 January 1993
DATE OF MOST RECENT AMENDMENT:
12 November 2014