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Paxil: Us Fda
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In addition to suicide, Paxil has ... been associated with an increased risk of birth defects in babies born to women who use the drug while pregnant. In September 2005, the FDA warned that Paxil nearly doubled the risk of heart defects—particularly atrial septal and ventricular septal defects—when taken during the first trimester.
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The FDA noted in its warning that Paxil was not approved for use in children or adolescents and the drug is ineffective for treatment of major depressive order among younger patients. The FDA cited three clinical trials that failed to demonstrate Paxil offered any benefit to children suffering from major depressive disorder.
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Paxil is an antidepressant drug belonging to the class of medications known as the selective serotonin reuptake inhibitors (SSRIs). Drugs in this group affect levels of the chemicals that nerves in the brain use to communicate with one another, known as neurotransmitters. Many experts believe that an imbalance among the amounts of the different neurotransmitters in the brain leads to depression. The SSRI class ... contains fluoxetine (Prozac) and sertraline (Zoloft). Paxil is approved by the FDA for the treatment of depression and several other psychiatric disorders.
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PANIC DISORDER: The usual starting dose for Paxil is 10 milligrams a day, taken in the morning. At intervals of 1 week or more, the doctor may increase the dose by 10 milligrams a day. The target dose is 40 milligrams daily; dosage should never exceed 60 milligrams.
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The usual dose of Paxil is 20 mg taken once daily, usually in the morning. Paxil comes in either 20 mg tablets (pink) or 30 mg tablets (blue). For the depressed elderly, the recommended starting dose is 10 mg once daily. Physicians may change the dose by 10 mg at a time and the dose should not exceed 50 mg per day (40 mg in geriatric patients). There should be a one week interval between dose adjustments.
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[O]f the Paxil withdrawal suit, GlaxoSmithKline finally updated its Paxil label with a specific mention of the danger of Paxil withdrawal symptoms. The revised label uses the favorable term – discontinuation -- instead of withdrawal. Discontinuation is a euphemism for withdrawal used to circumvent the negative connotations associated with addiction, dependency, and withdrawal syndromes. By using the term discontinuation instead of withdrawal, GlaxoSmithKline obscures the potential severity of Paxil withdrawal symptoms.
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