PAXIL (paroxetina) medicina para la depresion, asociada a suicidio y malformaciones fetales !!!

Data-Medicos 
Dermagic/Express No. 9-(127) 
30 Abril 2.007 / 30  April 2.007 
 

Probablemente otros antidepresivos esten involucrados tambien...

Other antidepressants are probably involved also...

Geetings to all

Dr. Jose Lapenta

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REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
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1.) FDA: Paxil May Raise Teen Suicide Risk
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2.) Paroxetina induce al suicidio
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3.) Paxil, informacion del producto
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4.) Paxil Raises Suicide Risk For Young Adults
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5.) Injured by Paxil?
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6.) BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)
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7.) Even more suicide attempts in clinical trials with paroxetine randomised against placebo
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8.) Suicide attempts in clinical trials with paroxetine randomised against placebo.
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9.) Paxil increases suicide risk: report
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10.) FDA: Paxil Linked To Birth Defects
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11.) Se Intensifica la advertencia sobre los defectos de nacimientos a causa del Paxil
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1.) FDA: Paxil May Raise Teen Suicide Risk
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Antidepressant Could Have Role In Suicidal Behavior, Says Manufacturer

Source: http://www.cbsnews.com/stories/2006/05/12/health/main1616056.shtml?source=search_story

WASHINGTON, May 12, 2006
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Fast Facts

Eight of the 11 suicide attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.
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The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration warned Friday in a letter to doctors.

The warning letter was accompanied by changes to the labeling of both Paxil and Paxil CR, a controlled-release version of the drug, also called paroxetine.

A recent analysis of clinical trial data on nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.

The FDA reported that there were 11 suicide attempts, none resulting in death, among the patients given Paxil in the trials. Just one of the dummy pill patients attempted suicide.

Given that small number, the results "should be interpreted with caution," the FDA said. Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.

GlaxoSmithKline released its findings following an FDA request that antidepressant manufacturers examine their clinical trial data for any links between the drugs and suicide in adults, company spokeswoman Mary Anne Rhyne said.

"At some point, the FDA is going to say what their analysis shows across the category," Rhyne said, adding of her company's own analysis: "We felt like this was information we wanted to share with physicians."

In the letter to doctors, Dr. John E. Kraus, the company's director of clinical development for clinical psychiatry in North America, said GlaxoSmithKline PLC continues to believe the drug's benefits outweigh its risks.

The FDA stressed that all patients, especially young adults and those who are improving, should be carefully monitored when treated with Paxil.

In 2004, the FDA ordered strong warnings about the pediatric risk of suicidal tendencies put on antidepressant labels, and began analyzing whether adults face a similar risk.

All antidepressants now carry warnings on their labels cautioning patients and doctors of the risk of suicidal behavior.

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2.) Paroxetina induce al suicidio
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Source: http://www.adaptogeno.com/svms/noticias/noticia3.asp

Un estudio reciente revela que el antidepresivo “Paroxetina” incrementa la actividad suicida.


En la última edición de la revista BMC Medicine, se publica un estudio realizado por investigadores del Departamento de Farmacoterapéutica de la Universidad de Oslo, Noruega, quienes evalúan los riesgos de utilizar paroxetina, un conocido antidepresivo.

Los autores analizaron 16 estudios previos en los cuales la paroxetina había sido evaluada mediante estudios aleatorios controlados y registraron el número de suicidios, intentos suicidas e ideación de suicidio. Luego contrastaron los datos contra los tratamientos con paroxetina o placebo.

Este estudio demostró el incremento de los intentos suicidas por año en adultos que utilizan paroxetina.

Los autores concluyen que tanto pacientes como médicos deben ser advertidos de que el aumento de la actividad suicida observada en niños y adolescentes que utilizan paroxetina, puede ocurrir también en adultos.

La paroxetina pertenece a una clase de medicamentos llamados inhibidores selectivos de la recaptación de serotonina, que aumentan la cantidad de serotonina cerebral con el propósito de mantener el equilibrio mental. Es mercadeada con varios nombres comerciales, de los cuales el más popular es “Paxil”.

La paroxetina puede producir otros efectos adversos, tales como: cefalea, mareos, debilidad, dificultad para concentrarse, nerviosismo, amnesia, confusión, somnolencia o sensación de estar narcotizado, dificultad para conciliar o mantener el sueño, acidez o dolor estomacal, vómitos, diarrea, estreñimiento, flatulencia, cambios en la capacidad de degustar los alimentos, disminución del apetito, pérdida o aumento de peso, cambios en el deseo o capacidad sexual, sequedad bucal, transpiración excesiva, bostezos, sensibilidad a la luz, secreción nasal, tos, opresión de garganta, debilidad o dolor osteo-muscular, rubor, problemas dentales, pesadillas, dolor o irregularidad en la menstruación.

Referencia:

Aursnes I, Tvete IF, Gaasemyr J. Suicide attempts in clinical trials with paroxetine randomised against placebo. BMC Med. 2005 Aug 22;3(1):14.

http://www.nlm.nih.gov/medlineplus/spanish/druginfo/medmaster/a698032-es.html

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3.) Paxil, informacion del producto
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Source: http://www.lawyerseek.com/Practice/En-Espanol-C22/Paxil-P103/

¿Qué es Paxil?

Paxil es un producto comercializado por GlaxoSmithKline, cuyo nombre genérico es hidroclorhidrato de paroxetina. Paxil está clasificado como un inhibidor de la recaptación de serotonina, un tipo de fármacos más conocidos como ISRS. Dentro de esta categoría, también se encuentran otros antidepresivos muy destacados, como Prozac y Zoloft. Paxil se prescribe para el tratamiento de depresión, trastorno obsesivo-compulsivo, trastorno de estrés postraumático y trastornos de pánico y ansiedad. La depresión puede ser un problema muy debilitante que afecta a millones de personas en todo el país, que se traduce en sentimientos de suma tristeza y sensación de inutilidad y desesperanza. Algunos estudios indican que la depresión puede tener origen en un desequilibrio de una sustancia química neurotransmisora del cerebro que se conoce con el nombre de serotonina. Paxil está diseñado para ampliar el uso de la serotonina en el cerebro y así mejorar el envío de los impulsos nerviosos, con la esperanza de tratar los síntomas de la depresión.

Recuadro negro de advertencia sobre Paxil y suicidio infantil

Diversos análisis de ensayos de corto plazo controlados con placebo en los que se investigaron nueve antidepresivos, entre ellos, los ISRS, revelaron que, durante los primeros meses de tratamiento, podría aparecer un aumento de conductas y pensamientos suicidas en niños. En los análisis se contemplaron 24 ensayos en los que participaron 4400 pacientes. Estos estudios indican que podría existir el doble de riesgo de suicidio en los niños a quienes se les administraron antidepresivos, en comparación con los participantes de los estudios que recibieron un placebo. En octubre de 2004, la FDA emitió una advertencia pública respecto de los antidepresivos y los posibles vínculos con un aumento de pensamientos suicidas en niños. La FDA ordenó a los fabricantes de antidepresivos que incluyan un "recuadro negro de advertencia" en las etiquetas de los fármacos, que alerte sobre el posible vínculo de los antidepresivos y el suicidio infantil. Paxil se encuentra entre los fármacos que deben llevar la nueva advertencia, junto con otros antidepresivos populares, como Wellbutrin, Zoloft y Prozac. El recuadro negro es la máxima advertencia que puede emitir la FDA. El texto que contiene el recuadro negro de advertencia debe incorporarse a la etiqueta y, además, a todo aviso publicitario del fármaco. El recuadro negro de advertencia de estos antidepresivos se refiere a la vinculación entre los antidepresivos y el suicidio infantil. Sin embargo, el vínculo entre el tratamiento con antidepresivos y un aumento de los pensamientos o actos suicidas podría aplicarse a adultos, niños y adolescentes.

Advertencia de malformaciones fetales y Paxil

Recientemente, la FDA ha informado que los resultados preliminares de nuevos estudios indican que Paxil podría provocar malformaciones fetales si se administra a mujeres durante el primer trimestre del embarazo (los tres primeros meses del embarazo). Las indicaciones iniciales de dos estudios revelan que las mujeres que tomaron Paxil durante el primer trimestre del embarazo podrían tener entre un 50% y 100% más de probabilidades de que sus hijos tengan defectos cardíacos, en comparación con mujeres en general y las que recibieron otro tipo de medicamentos antidepresivos. Según la FDA, las pacientes embarazadas o que tratan de quedar embarazadas y están tomando Paxil deben discutir con el médico los posibles efectos de este fármaco.

Preguntas y consultas

Si usted o un familiar suyo usaron el fármaco de venta con receta Paxil y han notado efectos secundarios adversos, como pensamientos suicidas o si su bebé sufrió malformaciones fetales, deben ponerse en contacto con un médico de inmediato. Si desea conocer sus derechos, le interesa recibir más información acerca de las causas judiciales sobre Paxil o desea compartir con nosotros información sobre estos casos, complete el breve formulario que se presenta a continuación y un integrante del experimentado personal de Seeger Weiss LLP se comunicará con usted para discutir sus posibles derechos legales por el uso de Paxil. Las consultas a los profesionales no le generan ningún compromiso. Todas las consultas iniciales son gratuitas y no crean una relación abogado-cliente. Seeger Weiss LLP tiene oficinas en Nueva York y Nueva Jersey, y sus profesionales ejercen en los tribunales de todo el país.

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4.) Paxil Raises Suicide Risk For Young Adults
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Source: http://www.medicalnewstoday.com/healthnews.php?newsid=43351

GlaxoSmithkline, the makers of the antidepressant, Paxil, have warned that the drug may raise the risk of suicide attempts in people under 30. Glaxo has sent a letter to doctors stating this.

According to a clinical trial, of 3,455 people taking Paxil 11 tried to kill themselves. Among the placebo group of 1,978 people, 1 tried to commit suicide. The majority of suicide attempts were made by patients under 30. One of the Paxil patients who attempted suicide succeeded.

Mary Anne Rhyne, who works for Glaxo, said the company is advising doctors to monitor all patients to make sure their symptoms don't worsen while they are taking Paxil.

The FDA says doctors and patients should follow current advice. The agency is still analysing the results of the trial.

A spokesman for the FDA said it is important that patients on Paxil do not suddenly stop taking their medication without first consulting with their doctors.

Written by: Christian Nordqvist
Editor: Medical News Today

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5.) Injured by Paxil?
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Source: http://www.yourlawyer.com/topics/overview/paxil

On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.

The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.

In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk.

New Paxil Suicide Warning
Paxil (Generic: Paroxetine hci) has been linked with suicide, suicidal ideation and violence in children and teenagers. On May 12, 2006, the FDA issued a Paxil warning when results of a study became public showing that Paxil also increases suicide risk in young adults aged 18-30. An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the pacebo. Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30. Paxil is most commonly used to treat depression but is also prescribed to treat anxiety, panic, obsessive compulsive disorder, and post traumatic stress disorder. An estimated 17 million people worldwide have been treated with Paxil.

In September 2004, the FDA issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. This follows a report issued by Britain's Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil. British health regulators recently issued a warning and stated: "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks." Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland, and the FDA continues to investigate the suicide risk associated with Paxil and other antidepressants.

Birth Defects
The FDA is strengthening its warning for the antidepressant Paxil because it may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects. The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name Paroxetine, as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. Two studies of pregnant women taking Paxil during their first trimester showed that their babies have heart defects at a rate of 1.5 to 2 times the norm. The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.

Withdrawal Symptoms
Paxil has long been associated with difficult withdrawal side effects, leaving patients virtually addicted to the drug. Recently, The British drug agency required Glaxo to remove a statement on its patient label saying that the drug was not addictive. Paxil has been associated with difficult withdrawal side-effects. Often these withdrawal effects are experienced just hours after a missed dose. Paxil withdrawal symptoms include a "flu-like" syndrome, anxiety, dizziness, fatigue, headache, migraine-like feelings, nerves jangling when moving eyes, continuous indigestion, neck and back pain, psychotic features such as visual and/or audio hallucinations/illusions, insomnia, nausea, restlessness, "electrical shock" phenomena/electrical surges or shocks through the head and/or body, hyper-sensitivity of the nervous system to light, sound, colors & stressors, tremors, tinnitus and a vertiginous-like experience, depressive thoughts, suicidal thoughts, homicidal thoughts, extreme anger, severe agitation, extreme irritability, "over-reacting", ringing in ears and throbbing in head, vomiting, paranoia, aggressive behavior, roller-coaster emotions, out of character behavior, severe malaise, general dysphoria, derealization and panic attacks.

In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs.

During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.

Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.

If you or a loved one took Paxil and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.


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6.) BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)
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Jan 31, 2007

Source: http://www.yourlawyer.com/articles/read/12494

According to journalists at the BBC, GlaxoSmithKline intentionally distorted and covered up damaging information about their antidepressant Seroxat and its link to an increased risk of suicide in children. Researchers for the BBC documentary series Panorama obtained three critical documents suggesting that the company had conducted trials proving the drug was unsafe, but failed to accurately disclose that information. (Seroxat is a brand name for paroxetine, a selective serotonin reuptake inhibitor (SSRI) class of antidepressant marketed in the U.S. as Paxil.)

The BBC’s website reports: “GSK’s biggest clinical trial of Seroxat on children was held in the U.S. in the 1990s and called Study 329. Child psychiatrist Dr. Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329. In 2002, he also gave a talk on childhood depression at a medical conference sponsored by GSK. He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.”

The BBC program quotes U.S. attorney Karen Barth Menzies as saying, “They didn’t tell the regulators or the physicians or parents about these risks or the lack of efficacy; instead they went out and promoted this specific study as remarkably effective and safe for kids.”

The BBC’s Jofre later discovered that, after sending questions about the safety of Seroxat to Ryan in 2002, Ryan forwarded them to GSK asking for advice on how to respond. Jofre also found an email from a public-relations executive, saying, “Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicize.”

The Panorama investigation also found two other incriminating documents, one from GSK’s marketing department in 1999 that acknowledged the safety risks and another from 2001 that reiterated to its sales staff the safety and efficacy of the drug in treating adolescents even after the company was aware of the side effects.

“Even when they have negative studies that show that this drug Seroxat is going to harm some kids, they still spin that study as remarkably effective and safe for children,” added Menzies, a plaintiff attorney in a U.S. suit facing GSK over the drug.

Roughly 50,000 British children took the drug before it was banned in 2003 for use by patients under the age of 18. The documentary claims that GSK knew of the risks in the late 1990s.

In a statement responding to the BBC allegations, Glaxo says: “No suicides were reported in any of the nine pediatric trials conducted by GSK and when reviewed individually none of these trials were considered by GSK or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.

“Only when all the data became available, at the end of the research program, and were analyzed together, was an increased rate of suicidal thinking or attempted suicide revealed in those pediatric patients taking Seroxat.”

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7.) Even more suicide attempts in clinical trials with paroxetine randomised against placebo
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.Aursnes I, Tvete IF, Gaasemyr J, Natvig B.

BMC Psychiatry. 2006 Nov 28;6:55.

Department of Pharmacotherapeutics, University of Oslo, Oslo, Norway. [email protected]

Source: http://www.ncbi.nlm.nih.gov/

BACKGROUND: Following our previous publication we have received critical comments to our conclusions as well as new data that are strengthening our findings. RESULTS: With the new data, 11 suicide attempts among patients on paroxetine against 1 among patients on placebo, we found with a Bayesian technique that the posterior probability that medication with paroxetine is associated with an increased intensity per year of a suicide attempt is from 0.98 to 0.99, depending on the prior.We found that the comment to our article by GSK representatives contained errors, misunderstanding and unwillingness to accept Bayesian principles in the analysis of clinical trials. CONCLUSION: We were in our previous publication, with preliminary data and a Bayesian approach, able to raise a concern that suicide attempts might be connected with the use of paroxetine. This suspicion has now been confirmed.

PMID: 17129393 [PubMed - indexed for MEDLINE]

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8.) Suicide attempts in clinical trials with paroxetine randomised against placebo.
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Aursnes I, Tvete IF, Gaasemyr J, Natvig B.
Department of Pharmacotherapeutics, University of Oslo, Oslo, Norway. [email protected]
BMC Med. 2005 Aug 22;3:14.

Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=16115311

BACKGROUND: Inclusion of unpublished data on the effects of antidepressants on children has suggested unfavourable risk-benefit profiles for some of the drugs. Recent meta-analyses of studies on adults have indicated similar effects. We obtained unpublished data for paroxetine that have so far not been included in these analyses. METHODS: The documentation for drug registration contained 16 studies in which paroxetine had been randomised against placebo. We registered the number of suicides, suicide attempts and ideation. We corrected for duration of medication and placebo treatment and used a standard Bayesian statistical approach with varying priors. RESULTS: There were 7 suicide attempts in patients on the drug and 1 in a patient on placebo. We found that the probability of increased intensity of suicide attempts per year in adults taking paroxetine was 0.90 with a "pessimistic" prior, and somewhat less with two more neutral priors. CONCLUSION: Our findings support the results of recent meta-analyses. Patients and doctors should be warned that the increased suicidal activity observed in children and adolescents taking certain antidepressant drugs may also be present in adults.

PMID: 16115311 [PubMed - indexed for MEDLINE]
 

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9.) Paxil increases suicide risk: report
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Antidepressant increased suicide attempt in adults, says study, which Glaxo calls "misleading."
August 22, 2005: 1:00 PM EDT

Source: http://money.cnn.com/2005/08/22/news/international/paxil/index.htm

NEW YORK (CNN/Money) - Paxil, a blockbuster antidepressant from British drug maker GlaxoSmithKline, increases the risk of suicide in adults, according to a study by Norwegian researchers

Patients taking Paxil, a $1.9 billion drug also known by its generic term paroxetine, attempted suicide seven times, compared to one suicide attempt in placebo studies, according to a report by Ivar Aursnes and other Norwegian researchers and published in BMC Medicine on Aug. 22.

"Summarizing the suicide attempts, there are seven among the patients on paroxetine and one among the patients on placebo," read the report, which said there were 16 studies conducted with 916 patients on Paxil and 550 on placebo.


GlaxoSmithKline (down $0.06 to $48.15, Research), a London-based drug maker with $39 billion in 2004 sales, criticized the study as "misleading" and based on outdated and "incorrectly selected" data.

"The company disagrees with the conclusion from the sub-analysis conducted by scientists based in Oslo," said GlaxoSmithKline in a prepared statement. "It serves only to cause confusion and unnecessary concern for patients using an SSRI (selective serotonin reuptake inhibitor,) such as paroxetine, for treatment of depression."

The suicidal side effects of antidepressants has raised concerns with the Food and Drug Administration, which now requires all antidepressants to carry warnings about the increased risk of suicide to children and teenagers. On June 30, the FDA said it is conducting a review of available data to determine whether there is an increased risk of suicidal thinking in adults who are taking antidepressants. The FDA expects to take at least a year to complete this review.

The scientists who conducted the Paxil study suggested that adults be included in regulatory warnings.

"We also conclude that the recommendation of restrictions on the use of paroxetine for children and adolescents recently conveyed by regulatory agencies should be extended to include usage by adults," read the report.

To read about the impact of antidepressant suicide risks and other factors on the drug industry's reputation, click here.

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10.) FDA: Paxil Linked To Birth Defects
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ut Benefits Of Antidepressant May Outweigh Risk, Agency Says

Source: http://www.cbsnews.com/stories/2005/12/08/health/main1108452.shtml

WASHINGTON, Dec. 8, 2005
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Fast Fact

The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or who are planning to become pregnant.
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The Food and Drug Administration is strengthening its warning that the antidepressant Paxil may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects.

The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name paroxetine, as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. However, the FDA said, the benefits of the drug may outweigh the risk to the fetus.

Two studies of pregnant women taking Paxil during their first trimester have shown their babies have heart defects one and a half to two times a greater rate than the norm, the FDA said. The agency announced the strengthened warning Thursday. It issued a previous warning in September.

The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.


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11.) Se Intensifica la advertencia sobre los defectos de nacimientos a causa del Paxil
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Un nuevo estudio asocia a Paxil con la causa del doble número de defectos de nacimientos comparados con otros antidepresivos

Source: http://www.webmd.com/content/Article/113/110646.htm

By Miranda Hitti (en Español)

WebMD Medical News Reviewed By Michael Smith, MD (en Español)
on Wednesday, October 05, 2005

27 de septiembre, 2005 - La FDA y la compañía de drogas GlaxoSmithKline están advirtiendo a los doctores sobre un nuevo estudio acerca de los principales efectos de nacimientos que se han visto en los bebés nacidos de mujeres que tomaron el antidepresivo Paxil durante el primer trimestre del embarazo.

"Se les ha aconsejado a los profesionales del cuidado de la salud que consideren cuidadosamente los riesgos potenciales y los beneficios de usar [Paxil] en las mujeres durante el embarazo y discutir estos descubrimientos, también como, las alternativas de tratamientos con sus pacientes," así lo declara la FDA en un comunicado de prensa.

Paxil está asociado con el doble número de defectos de nacimientos

GlaxoSmithKline recientemente llevó a cabo un estudio de los principales defectos de nacimientos en infantes nacidos de mujeres que tomaron antidepresivos (incluyendo Paxil) durante el primer trimestre del embarazo.

De acuerdo a la FDA, en un estudio de más de 3,500 mujeres embarazadas, Paxil fue asociado con el doble número de defectos de nacimientos, así como otros antidepresivos.

Los defectos de nacimientos son muy raros en los EE.UU., y no es seguro qué papel, si hay alguno, Paxil jugó en los defectos de nacimientos vistos en este estudio, lo afirma GlaxoSmithKline.

Los cambios han sido efectuados en la información de la etiqueta que trae Paxil sobre las precauciones en el embarazo, dice la FDA.

GlaxoSmithKline es un patrocinador de WebMD.

La mayoría de los defectos de nacimientos vistos en el estudio estaba relacionada con el corazón; las malformaciones más comunes en el corazón fueron defectos septales ventriculares, los cuales son agujeros entre las dos paredes principales que bombean sangre al corazón. Estos son en general defectos comunes.

El estudio fue un estudio epidemiológico retrospectivo. Eso significa que observaron a un gran grupo de personas posteriormente. No había información sobre los defectos de nacimientos en bebés nacidos de mujeres que no tomaron antidepresivos durante los comienzos del embarazo.



 

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DATA-MEDICOS/DERMAGIC-EXPRESS No 9-(127)  30/04/2.007 DR. JOSE LAPENTA R. 
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