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  • Fake Valium Tablets -ALERT

    Posted on February 11th, 2011 TimB No comments

    We recently received two tablets for analysis. Tablets are pale blue/green in colour and scored on one side and labelled ‘Roche 10’on the other side. Blister packaging says Valium (Diazepam) 10mg.

    It appears they may be from Pakistan . Also, visible on the pack are the ends of words _tan Limited and submitted by addiction services in the North Dublin area but reportedly the tablets are being purchased in the city centre.
    and when the tablets are not effective, people are taking more of them.(may be taking as many as 6-10 tablets)
    According to the outreach worker in North Dublin who sourced these tablets, there have been many adverse effects seen with these fake Valium tablets including 2 x chronic nose bleeds lasting days, 2 x mild heart attacks (A&E admitted), Stroke (A&E), vomiting, sweating, fainting.
    We have analysed the tablets and they do not contain Diazepam (Valium). The main active drug in the tablets is Melatonin. There was a also possible trace of demoxepam.

    Principal Biochemists

    The Drug Treatment Centre Board,

    .8 Undesirable effects

    In clinical trials (in which a total of 1931 patients were taking Circadin and 1642 patients were taking placebo), 48.8% of patients receiving Circadin reported an adverse reaction compared with 37.8% taking placebo. Comparing the rate of patients with adverse reactions per 100 patient weeks, the rate was higher for placebo than Circadin (5.743 – placebo vs. 3.013 – Circadin). The most common adverse reactions were headache, nasopharyngitis, back pain, and arthralgia, which were common, by MedDRA definition, in both the Circadin and placebo treated groups.

    The following adverse reactions were reported in clinical trials and were defined as possibly, probably or definitely related to treatment. A total of 9.5% of subjects receiving Circadin reported an adverse reaction compared with 7.4% of subjects taking placebo. Only those adverse events occurring in subjects at an equivalent or greater rate than placebo have been included below.

    Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

    System Organ Class Very Common Common Uncommon Rare
    Infections and Infestations Herpes zoster
    Blood and Lymphatic System Disorders Leukopenia, Thrombocytopenia
    Cardiac Disorders

    Angina Pectoris, Palpitations

    Metabolism and Nutrition Disorders

    Hypertriglyceridaemia, Hypocalcaemia, Hyponatraemia

    Psychiatric Disorders Irritability, Nervousness, Restlessness, Insomnia, Abnormal dreams, Anxiety

    Mood altered, Aggression, Agitation, Crying, Stress Symptoms, Disorientation, Early morning awakening, Libido increased, Depressed mood, Depression

    Nervous System Disorders Migraine, Lethargy, Psychomotor hyperactivity, Dizziness, Somnolence

    Syncope, Memory impairment, Disturbance in attention, Dreamy state, Restless Legs Syndrome, Poor quality sleep, Paresthesia

    Eye Disorders

    Visual acuity reduced, Vision blurred, Lacrimation increased

    Ear and Labyrinth Disorders

    Vertigo positional, Vertigo

    Vascular Disorders Hypertension

    Hot flush

    Gastrointestinal Disorders Abdominal pain, Abdominal pain upper, Dyspepsia, Mouth Ulceration, Dry Mouth

    Gastrooesophageal Reflux Disease, Gastrointestinal disorder, Oral Mucosal Blistering, Tongue Ulceration, Gastrointestinal upset, Vomiting, Bowel sounds abnormal, Flatulence, Salivary hypersecretion, Halitosis, Abdominal Discomfort, Gastric disorder, Gastritis

    Hepatobiliary Disorders Hyperbilirubinaemia
    Skin and Subcutaneous Tissue Disorders Dermatitis, Night Sweats, Pruritus, Rash, Pruritus Generalised, Dry Skin

    Eczema, Erythema, Hand Dermatitis, Psoriasis, Rash Generalised, Rash pruritic, Nail disorder

    Musculoskeletal and Connective Tissue Disorders Pain in extremity

    Arthritis, Muscle spasms, Neck pain, Night cramps

    Reproductive System and Breast Disorders Menopausal Symptoms

    Priapism, Prostatitis

    General Disorders and Administration Site Conditions Asthenia, Chest Pain

    Fatigue, Pain, Thirst

    Renal and Urinary Disorders Glycosuria, Proteinuria

    Polyuria, Hematuria, Nocturia

    Investigations Liver Function Test Abnormal, Weight increased

    Hepatic enzyme increased, Blood Electrolytes Abnormal, Laboratory test abnormal

    4.9 Overdose

    No case of overdose has been reported. Circadin has been administered at 5 mg daily doses in clinical trials over 12 months without significantly changing the nature of the adverse reactions reported.

    Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature.

    If overdose occurs, drowsiness is to be expected. Clearance of the active substance is expected within 12 hours after ingestion. No special treatment is requireed


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