PAXIL (paroxetina) medicina para la depresion, asociada a suicidio y malformaciones fetales !!!
PAXIL (paroxetin) drug for depression linked to suicide, and births defects !!!
PUBLICADO 2007 ACTUALIZADO 2023
EDITORIAL ESPAÑOL
==============
Medicamento lanzado al mercado en 1.992, años después se revelaron sus efectos adversos
La paroxetina es un medicamento que pertenece a una clase de medicamentos llamados inhibidores selectivos de la recaptación de serotonina (ISRS) y se utiliza para tratar la depresión y otras enfermedades mentales aumentando la cantidad de serotonina, una sustancia natural del cerebro que ayuda a mantener el equilibrio mental.
Se ha informado que una pequeña cantidad de niños, adolescentes y adultos jóvenes (de hasta 24 años) que tomaron antidepresivos como la paroxetina durante los estudios clínicos desarrollaron tendencias suicidas (pensar en hacerse daño o quitarse la vida, o planear o intentar hacerlo)¹. Los niños, adolescentes y adultos jóvenes que toman antidepresivos para tratar la depresión u otras enfermedades mentales pueden ser más propensos a desarrollar tendencias suicidas que aquellos que no toman antidepresivos para tratar dichos trastornos. Sin embargo, también hay riesgos cuando no se trata la depresión en niños y adolescentes.
La paroxetina es un medicamento que pertenece a una clase de medicamentos llamados inhibidores selectivos de la recaptación de serotonina (ISRS) y se utiliza para tratar la depresión y otras enfermedades mentales aumentando la cantidad de serotonina, una sustancia natural del cerebro que ayuda a mantener el equilibrio mental.
OTROS EFECTOS SECUNDARIOS
1. Náusea
2. Somnolencia
3. Sudoración
4. Temblor
5. Astenia
6. Sequedad de boca
7. Disfunción sexual
8.) Malformaciones Fetales.
==================
Geetings to all
Dr. Jose Lapenta
=====================================================
REFERENCIAS BIBLIOGRAFICAS / BIBLIOGRAPHICAL REFERENCES
=====================================================
1.) FDA: Paxil
May Raise Teen Suicide Risk
====================================================
2.) Paroxetina induce al suicidio
=====================================================
3.)
Paxil, informacion del producto
=====================================================
4.)
Paxil Raises Suicide Risk For Young Adults
=====================================================
5.)
Injured by Paxil?
=====================================================
6.)
BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)
=====================================================
7.)
Even more suicide attempts in clinical trials with paroxetine randomised
against placebo
=====================================================
8.)
Suicide attempts in clinical trials with paroxetine randomised against
placebo.
=====================================================
9.)
Paxil increases suicide risk: report
=====================================================
10.)
FDA: Paxil Linked To Birth Defects
=====================================================
11.)
Se Intensifica la advertencia sobre los defectos de nacimientos a causa
del Paxil
=====================================================
=====================================================
1.) FDA: Paxil
May Raise Teen Suicide Risk
====================================================
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
--------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------
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.
=====================================================
2.)
Paroxetina induce al suicidio
=====================================================
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
=====================================================
3.) Paxil,
informacion del producto
=====================================================
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.
=====================================================
4.)
Paxil Raises Suicide Risk For Young Adults
=====================================================
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
=====================================================
5.)
Injured by Paxil?
=====================================================
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.
=====================================================
6.)
BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)
=====================================================
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.”
=====================================================
7.)
Even more suicide attempts in clinical trials with paroxetine randomised
against placebo
=====================================================
.Aursnes
I, Tvete IF, Gaasemyr J, Natvig B.
BMC Psychiatry. 2006 Nov 28;6:55.
Department of
Pharmacotherapeutics, University of Oslo, Oslo,
Norway. i.a.aursnes@medisin.uio.no
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]
=====================================================
8.)
Suicide attempts in clinical trials with paroxetine randomised against
placebo.
=====================================================
Aursnes
I, Tvete IF, Gaasemyr J, Natvig B.
Department of
Pharmacotherapeutics, University of Oslo, Oslo,
Norway. i.a.aursnes@medisin.uio.no
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]
=====================================================
9.) Paxil
increases suicide risk: report
=====================================================
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.
=====================================================
10.)
FDA: Paxil Linked To Birth Defects
=====================================================
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
--------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------
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.
=====================================================
11.)
Se Intensifica la advertencia sobre los defectos de nacimientos a causa
del Paxil
=====================================================
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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