tag:blogger.com,1999:blog-8185510671645413282024-03-19T04:36:11.077-07:00PaxilpaxilUnknownnoreply@blogger.comBlogger10125tag:blogger.com,1999:blog-818551067164541328.post-19743514225001052062012-11-05T16:05:00.003-08:002012-11-05T16:05:59.020-08:00<div align="justify">
Teenagers and young adults who use anti-depressant Paxil face a lower risk of suicide attempt than depressed patients who are not undergoing drug treatment.<br />
<br />
The findings contradict previous research that led the US government's Food and Drug Administration to warn that Paxil drugs increase the risk of suicidal behavior in young people.<br />
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The study focused on selective serotonin reuptake inhibitor (SSRI) medications, including Lexapro, Paxil, Zoloft and Prozac, a newer class of anti-depressants which regulate mood by adjusting the brain chemical serotonin.<br />
<br />
The risk of suicide attempt among depressed patients treated with Paxil was about one-third that of patients who were not treated with an SSRI, said study author.<br />
<br />
The study tracked 226,866 patients who were newly diagnosed with depression between 2003 and 2004 and compared the risk of suicide among four age groups before and after SSRI treatment.<br />
<br />
All groups who were treated with SSRI medications showed a lower risk of suicide attempt, said the study which appears in the July issue of the American Journal of Psychiatry.<br />
<br />
In 2004, the FDA linked teen suicide and the use of Paxil after the results of clinical trials conducted by pharmaceutical laboratories showed a relationship between the anti-depressant and an increase in suicidal behavior among children.</div>
Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-818551067164541328.post-92018960824047536612012-11-05T16:05:00.002-08:002012-11-05T16:05:38.463-08:00ParoxetineThe Food and Drug Administration (FDA) has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA's request, the manufacturer has changed paroxetine's pregnancy category from C to D and added new data and recommendations to the Warnings section of paroxetine's prescribing information. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride.<br /><br />The FDA's conclusions and changes in paroxetine's prescribing information are based on preliminary analyses of two recent unpublished epidemiology studies.<br />In a study using Swedish national registry data, women who received paroxetine in early pregnancy had an approximately 2-fold increased risk for having an infant with a cardiac defect compared to the entire national registry population (the risk of a cardiac defect was about 2% in paroxetine-exposed infants vs. 1% among all registry infants).<br />In a separate study using a United States insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall compared to infants of women who received other antidepressants in the first trimester. The risk of a cardiac defect was about 1.5% in paroxetine-exposed infants vs. 1% among infants exposed to other antidepressants.<br />Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own. It is of note that the data in these studies was limited to first trimester exposures only, and there are not currently data to address whether this or any other risk extends to later periods of pregnancy.<br /><br />The FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine. In the interim, FDA recommends the following:<br /><br />Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. In individual cases, the benefits of continuing paroxetine may outweigh the potential risk to the fetus. If the decision is made to discontinue paroxetine and switch to another antidepressant or cease antidepressant therapy, paroxetine discontinuation should be undertaken only as directed in the prescribing information. Paroxetine should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future.<br /><br />Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing the best way to do that with their physician.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-818551067164541328.post-12200582106796250142012-11-05T16:03:00.002-08:002012-11-05T16:03:56.977-08:00Paxil – Now for Premenstrual SyndromeIntermittent dosing with controlled-release paroxetine (Paxil-CR) has been shown effective in treating premenstrual syndrome. Also known as premenstrual dysphoric disorder or “PMDD”, the condition is characterized by a variety of symptoms, including severe depression, tensions and irritability before menstruation.<br /><br />The recent study by Meir Steiner, MD, of McMaster University, Hamilton, Ontario, and colleagues, was published in the American Journal of Obstetrics and Gynecology and reported by Reuters on 31 August 2005.<br /><br />"Both physicians and patients rate the treatment as being effective against the symptoms of PMDD. It also reduces the functional impairment that these patients experience," primary investigator Steiner told Reuters Health.<br /><br />Taking controlled-release paroxetine throughout the menstrual cycle has been shown effective in controlling PMDD symptoms. This study examined whether intermittent dosing was also effective.<br /><br />Study Protocol<br /><br />The researchers randomly assigned 373 patients with PMDD to receive three treatment cycles of paroxetine (12.5 mg or 25 mg) or placebo during the luteal phase of their menstrual cycle, two weeks after ovulation.<br /><br />PMDD symptoms normally start one week before menstruation and may last until a few days after menstruation starts, according to Steiner and colleagues.<br /><br />Assessment methods included mood scores, premenstrual tension scores and other measures, including patient-assessment of PMDD symptoms.<br /><br />Results & Conclusion<br /><br />Results showed that paroxetine-treated patients showed improvement over patients receiving placebo. Also, scores in the area of impairment of work and family life showed significant enhancement.<br /><br />Overall, improvements were similar to those observed in previous studies in which study subjects received paroxetine continuously throughout the menstrual period.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-818551067164541328.post-39484144249725503182012-11-05T16:02:00.005-08:002012-11-05T16:02:54.498-08:00Risk of Birth Defects with PaxilThe Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.<br /><br />FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.<br /><br />FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus. Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy. Women taking Paxil should not stop taking it without first talking with their physician.<br /><br />The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.<br /><br />In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.<br /><br />FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.<br /><br />Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-818551067164541328.post-76530391202183508612012-11-05T16:02:00.002-08:002012-11-05T16:02:26.664-08:00FTC chairman's statement on generic Paxil launchApotex Corp., confirmed that it was commencing U.S. sales of a generic version of the GlaxoSmithKline (Glaxo) antidepressant, Paxil.<br /><br />"Apotex was able to launch the product earlier than previously expected because Glaxo recently took actions to allow the Food and Drug Administration to approve the generic drug. Glaxo's actions followed an FDA rule-making and a series of Federal Trade Commission actions evidencing the FTC's concerns with Glaxo's practice of obtaining multiple delays of FDA approval of generic versions of Paxil. These developments are an example of how the FDA's new rule has accelerated generic drug competition.<br /><br />"The Commission has been investigating the potentially anti-competitive implications of Glaxo's listing of certain patents in the FDA's Orange Book. Patent listings can be the basis for a delay of FDA approval of generic drugs for 30 months, or even longer if a branded company lists multiple patents.<br /><br />"In July 2002, the Commission also issued a study, Generic Drug Entry Prior to Patent Expiration, that describes various pharmaceutical industry practices that trigger multiple 30-month stays of FDA approval of generic drug products. The Generic Drug Study, among other things, identified various categories of patents that raise questions about whether they are properly listed in the Orange Book and can be a basis for a 30-month stay. One such category is certain "product-by-process" patents. The Generic Drug Study noted that a number of product-by-process patents listed in the Orange Book for Paxil contained only process claims (which may not be listed), and claims drafted in the product-by-process format that recited an admittedly known drug substance made according to a purportedly novel process. In part by listing such patents, Glaxo obtained five overlapping 30-month stays -- extending to 65 months the period within which FDA was barred from granting final approval to generic versions of Paxil.<br /><br />"In October 2002, the FDA published a proposed rule-making to eliminate the multiple 30-month stays that the Generic Drug Study had identified as harmful to consumers. The Commission submitted comments to the FDA on its proposed rule. In that submission, the Commission recommended -- with express reference to Glaxo's patent listings for Paxil that 'the FDA should revise the text of the proposed regulation to reflect the fact that only product-by-process claims in which the product is novel should be listed'. In June 2003, the FDA published a final rule that responds, in part, to the Generic Drug Study and to the Commission's comments on the proposed rule. Consistent with the Commission's recommendations, the FDA limited the delay of FDA approval of a generic drug to a single 30-month period for any brand-name drug product, and confirmed that product-by-process patents are listable in the Orange Book only where the product claimed is novel.<br /><br />"Shortly after the FDA published the final rule in July 2003, Glaxo asked the FDA to de-list three Paxil-related patents, thus clearing the way for FDA to grant final approval to the generic drug. All three patents were among those identified in the Generic Drug Study as questionably listed, and one of those patent listings had resulted in a 30-month stay that was continuing to block generic entry. The FDA thereafter granted final approval to Apotex's product -- accelerating generic competition for Paxil that likely will bring substantial savings to consumers.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-818551067164541328.post-56669730564967591122012-11-05T16:01:00.000-08:002012-11-05T16:01:11.489-08:00What is paroxetineParoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paroxetine affects chemicals in the brain that may become unbalanced.<br /><br />Paroxetine is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).<br />
Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), linezolid (Zyvox), methylene blue (Urolene Blue), or a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). A dangerous drug interaction could occur, leading to serious side effects.<br /><br />Before you take paroxetine, tell your doctor if you have liver or kidney disease, a bleeding or blood clotting disorder, seizures, glaucoma, bipolar disorder, or a history of drug abuse or suicidal thoughts.<br />
There are many other drugs that can interact with paroxetine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Paroxetine may cause harm to an unborn baby. Tell your doctor right away if you become pregnant while taking paroxetine.<br /><br />Paroxetine may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy.<br /><br />Do not start or stop taking paroxetine during pregnancy without your doctor's advice.<br /><br />You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.<br /><br />Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.<br />
I was taking Paxil for both depression and anxiety. It worked very well for me for the past four years. My husband could definitely tell the difference, and if I missed a dose, the effect was immediate. However, I was not aware that it could cause weight gain, and I have gained over 40 pounds even though I am eating healthy and exercising.<br />
<br />Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-818551067164541328.post-77184053756629244812012-07-16T04:30:00.000-07:002012-07-16T04:30:04.689-07:00Some facts about PaxilOne of the most popular antidepressants is Paxil. Paxil is a prescription medication offered to patients suffering from other anxiety disorders and depression.
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<b>Symptoms of anxiety disorders</b>
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Anxiety disorders are experienced by many people. To find out if you're one of those people with panic disorder, here are the main symptoms. Panic attacks happen suddenly and are accompanied by intense discomfort, as a choking sensation, dizziness, heart palpitations, trembling, fear of dying, big sweats, etc..<br />
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<b>Side effects</b>
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The antidepressant Paxil produces many side effects. The most common are diarrhea, nausea, loss of appetite, dry mouth, headaches, etc.. We must take these medicines exactly as your doctor prescribes them. Also note that if your forgetfulness taking Paxil was less than two hours, you can take the usual dose. By cons, if your forgetfulness is more than two hours, it is better to wait until the next medication.
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<b>A drug to be taken seriously</b>
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The antidepressant Paxil is a very powerful drug and can not be stopped overnight. It should be the doctor's advice to stop taking it. Many people who have already taken Paxil complained of side effects from stopping this drug. You may feel electric shocks in the head, dizziness, and more. If you are taking Paxil, do not stop taking it especially on a whim!Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-818551067164541328.post-6188120322532429072007-08-17T02:33:00.001-07:002007-08-17T02:35:19.443-07:00Paxil. The new study.<div align="justify"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjxIOrbXo_pFlwRvOdSOeWSM8Wg3aP1o10MCcj8QZl0z-YgRhreJvhKNeRu2vkHXxjAL0cilizgT3YIOZ-5Vm-4pKUcaXZn9Frz_O-pRSe3C0oyEraTel7Uim2qwIyD1VIUScHFQScjY98N/s1600-h/paxile.jpg"><img id="BLOGGER_PHOTO_ID_5099600435433864594" style="FLOAT: left; MARGIN: 0px 10px 10px 0px; WIDTH: 200px; CURSOR: hand; HEIGHT: 189px" height="189" alt="" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjxIOrbXo_pFlwRvOdSOeWSM8Wg3aP1o10MCcj8QZl0z-YgRhreJvhKNeRu2vkHXxjAL0cilizgT3YIOZ-5Vm-4pKUcaXZn9Frz_O-pRSe3C0oyEraTel7Uim2qwIyD1VIUScHFQScjY98N/s320/paxile.jpg" width="220" border="0" /></a>Teenagers and young adults who use anti-depressant Paxil face a lower risk of suicide attempt than depressed patients who are not undergoing drug treatment.<br /><br />The findings contradict previous research that led the US government's Food and Drug Administration to warn that Paxil drugs increase the risk of suicidal behavior in young people.<br /><br />The study focused on selective serotonin reuptake inhibitor (SSRI) medications, including Lexapro, Paxil, Zoloft and Prozac, a newer class of anti-depressants which regulate mood by adjusting the brain chemical serotonin.<br /><br />The risk of suicide attempt among depressed patients treated with Paxil was about one-third that of patients who were not treated with an SSRI, said study author.<br /><br />The study tracked 226,866 patients who were newly diagnosed with depression between 2003 and 2004 and compared the risk of suicide among four age groups before and after SSRI treatment.<br /><br />All groups who were treated with SSRI medications showed a lower risk of suicide attempt, said the study which appears in the July issue of the American Journal of Psychiatry.<br /><br />In 2004, the FDA linked teen suicide and the use of Paxil after the results of clinical trials conducted by pharmaceutical laboratories showed a relationship between the anti-depressant and an increase in suicidal behavior among children. </div>Unknownnoreply@blogger.com1tag:blogger.com,1999:blog-818551067164541328.post-11050675738781773192007-08-02T03:25:00.000-07:002007-08-02T03:26:22.449-07:00Paxil makers failed to disclose informationGlaxoSmithKline, the maker of the antidepressant Paxil, failed to disclose information about the possibility of a risk of suicidal behavior in children taking the drug, as well as withdrawal symptoms when some patients stop taking Paxil.Earlier this year, the Food and Drug Administration ordered manufacturers to place a warning on antidepressants, pointing that the drugs can cause suicidal tendencies in children.Internal studies of GlaxoSmithKline reports, that some children showed the some types of suicidal thoughts and behaviors. The studies concluded that Paxil had little or no effect in treating depression in children and adolescents.Additionally, the internal report reveals that Paxil could cause mild to severe withdrawal symptoms in some patients when they stopped taking the drug. The documents suggest GlaxoSmithKline's sales strategy was to downplay this information.Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-818551067164541328.post-9610171961547889512007-08-02T03:22:00.000-07:002007-08-02T03:24:56.713-07:00Paxil and pregnancyPregnant women and those planning to become pregnant should avoid taking Paxil and other antidepressants if possible. There is opinion that the drug poses a risk to the fetus.Several studies have shown that babies have heart defects at a rate that is as much as twice the norm (when pregnant women were taking Paxil during first trimester). The decision whether to treat pregnant women with antidepressants that includes Prozac, Zoloft, Lexapro and Paxil, should be made on an individual basis.Reproductive-age women have the highest prevalence of major depressive disorders and the benefit of the treatment with any of the antidepressants may outweigh the risk to the fetus.According the above information GlaxoSmithKline Inc. (Manufacturer of Paxil) has issued a warning to physicians, as it may put women at an added risk for birth defects.Unknownnoreply@blogger.com1