Cephalon’s Provigil reported to cause life-threatening Skin rash and Psychiatric symptoms. US Food and Drug Administration (FDA) added this new warning to this sleep drug. Provigil is used for Obstructive sleep apnea, shift-work sleep disorder and Narcolepsy. Provigil is prescribed to improve wakefulness in those patients. FDA advised doctors not to prescribe this drug to patients with a history of depression or mania as Provigil causes hallucinations or suicidal thoughts in them. FDA approved Provigil in 1998 for use in adult patients. Side effects of Provigil: Most of these side-effects occur within 5 weeks of Provigil therapy. Psychological symptoms will stop within 3 days of stopping the drug. 1. Serious skin rashes like Stevens - Johnson syndrome, Toxic Epidermal Necrolysis and Eosinophilia. 2. Psychiatric symptoms like anxiety, mania, hallucinations and suicidal tendency. 3. Angiodema. 4. Multi-organ hypersensitivity reactions. Patients should immediately stop the drug if they find any of the above symptoms and consult doctor. Provigil is not approved for use in Pediatric patients. This is another major blow for Cephalon after Fentora (Cancer drug) issue. Source: FDA (Food and Drug Administration). … [Read more...]
Why suicide rates are rising in American youth?
According to CDC (Centre for disease control and prevention), Suicide rates for males and males in America aged 10-24 rose by 8%. This is the largest 1-year rise in 15 years. Suicide rates which are in decline from 1990 onwards are again rising especially in youth. Suicide rates are almost doubled in the 10-14 year old girls. We may know in the coming years whether it is a changing trend or statistical fluctuation. It is not a surprise to see “how to commit suicide?” and “best way to commit suicide” as popular Google search terms. If you check Google trends for suicide, 7 out of top 10 cities are American cities. Most surprising aspect is increase in suicide rates coincided with decrease in SSRI prescription rates. But we should not come to conclusion just basing on 1 year data. In late 2004, Food and Drug Administration called drug manufacturers to put a “Blackbox” warning on the drug labels, cautioning about the possibility of increased suicide risk in minors. Contrary to FDA reports, several research studies conducted in the last year suggested that antidepressants are more likely to reduce suicide risk than increase it. According to a research study published in American journal of Psychiatry, decrease in prescription of anti-depressants by few percentage points, coincided with 14% spike in suicide rates. Along with changes in prescriptions, increased rates of mental health disorders and increase in Alcohol and drug use are other causes for these suicides. Most common methods used to commit suicide: 1. 1990: The most common method was with a firearm for both males and females. 2. 2004: The most common method was by hanging/suffocation among girls. 3. 2004: Boys used forearms to commit suicide as the common method. We may need more comprehensive approach to control the rising suicide rates in American youth. FDA should conduct more research studies to know the effects of antidepressants on suicide rates especially in youth. Please share your opinion. … [Read more...]
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