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...]
Breast cancer drug for bipolar disorder
The breast cancer drug, Tamoxifen, has shown its effectiveness in treating the manic episodes of bipolar disorder. More than 5 million Americans suffer from bipolar disorder. These findings came from a double-blind, placebo-controlled study of 16 patients with bipolar disorder with or without psychotic features. Bipolar disorder is characterised by alternate periods of severe depression and mania. These people are high risk cases for suicide as highs of a manic episode might be followed by a period of depression. Lithium is the drug of choice for bipolar disorder. But it is ineffective in some cases with more side effects. How Tamoxifen is effective against bipolar disorder? Protein Kinase C (PKC) in the brain cells activates receptors on the surface of brain cells and modifying how well they receive signals. Tamoxifen inhibits the action of PKC. Biggest advantage of Tamoxifen is it can cross blood brain barrier. 63% of the patients who received Tamoxifen had reduced manic symptoms during the three week trial, only 13% of their control counterparts given a placebo showed this improvement. And the Tamoxifen appeared to have this impact quickly – within five days. By comparison, current drugs to treat manic episodes generally take at least a week to produce an effect. Tamoxifen itself should not be used as a treatment for bipolar disorder as it interferes with the hormone oestrogen. It can cause early menopause. Tamoxifen causes endometrial cancer on prolonged usage. More clinical trials should be done to develop a drug that can inhibit Protein Kinase without any effect on estrogens. Chelerythrine, PKC inhibitor, is in the early stages of clinical trials. Tamoxifen is the best drug for breast cancer patients who are suffering from manic-depressive disorder. … [Read more...]
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