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DRUG ALERTS
Effexor, Paxil, Wellbutrin,
and Serzone
On June 30, 2004, the FDA and Wyeth Pharmaceuticals notified
healthcare professionals of revisions
to the WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION
sections of
Effexor (venlafaxine) labeling to alert healthcare providers
of two important safety issues.
Newborns exposed to Effexor, other SNRIs (Serotonin and
Norepinephrine Reuptake Inhibitors), or SSRIs (Selective
Serotonin Reuptake Inhibitors), taken by the mother late
in the third trimester of pregnancy have developed complications
requiring prolonged hospitalization, respiratory support,
and tube feeding. Such complications can begin immediately
after birth of the baby.
Patients with major depressive disorder, both adult and
pediatric, may experience worsening of their depression and/or
the emergence of suicidal ideation and behavior (suicidality),
whether or not they are taking antidepressant medications.
The warning recommends patients being treated with antidepressants
be observed closely for clinical worsening and suicidality,
especially at the beginning of a course of drug therapy,
or at the time of dose changes, either increases or decreases.
Paxil (back
to top)
On June 22, 2004, FDA and GlaxoSmithKline notified healthcare
professionals of revisions to
the WARNINGS and PRECAUTIONS sections for the anti-depressant
/ anti-anxiety drug Paxil (paroxetine hydrochloride). The
new labeling requirement by the FDA is intended to alert
healthcare professionals that patients with major depressive
disorder, both adult and pediatric, may experience worsening
of their depression and/or the emergence of suicidal ideation
and behavior (suicidality).
The warning recommends patients being treated with antidepressants
be observed closely for clinical worsening and suicidality,
especially at the beginning of a course of drug therapy,
or at the time of dose changes, either increases or decreases.
The Truth About Paxil
FDA Did Not Make a Strong Enough WARNING about
PAXIL
In June, 2003 the Food and Drug Administration (FDA) recommended
that use of the popular antidepressant Paxil be discontinued
for children under 18, but now mention of that recommendation
has been added to the Drug WARNINGS. The action followed
a ban on Paxil by the British Medicines and Healthcare Products
Regulatory Agency and an evaluation of the entire class of
selective serotonin reuptake inhibitor antidepressants, which
includes Prozac, among others.
Paxil is manufactured by GlaxoSmithKline, based in the
United Kingdom. It is the second-most popular antidepressant
in the United States, with $2.5 billion in sales in 2002.
"The FDA received information from reports in clinical
trials in pediatric patients that showed that Paxil in this
population is associated with an increased risk of suicidal
thinking, and three clinical studies that failed to show
that the drug was more effective than placebo," said
FDA spokeswoman Susan Cruzan. Dr. Cruzan also emphasized
that Paxil has never been approved by the FDA for use in
children under 18.
On June 23, 2004, the FDA and Bristol-Myers Squibb notified
healthcare professionals of revisions
to the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION,
and WARNINGS
sections for the anti-depressant drug Serzone. The new
labeling is designed to encourage healthcare providers to
consider the more thoroughly the risk of liver failure associated
with Serzone treatment, when deciding among alternative treatments
available for depression.
In addition, healthcare providers and consumers are cautioned
about the need for close observation
of patients being treated with antidepressants for clinical
worsening of the symptoms of depression, for the emergence
of suicidality, and for the emergence of a variety of other
symptoms that may represent a worsening of the patient's
condition.
In other words, post clinical trials of this drug are now
showing a significant increase of patients who actually get
more depressed when put on Serzone than before it and some
even become suicidal.
On June 23, 2004, the FDA and GlaxoSmithKline notified
healthcare professionals of revisions to
the WARNINGS and PRECAUTIONS sections of yet a third antidepressant,
Wellbutrin (bupropion
hydrochloride). The new labeling is designed to alert healthcare
professionals that patients with
major depressive disorder, both adult and pediatric, may
get worse or even suicidal while taking Wellbutrin.
Bottom line: You
should avoid Effexor, Paxil, Serzone, Wellbutrin and all
the other drugs like them. There are natural alternatives
to all of these drugs. To learn more about natural alternatives
to these drugs and how to test your brain’s balance
of neurotransmitters associated with anxiety and depression,
click on the images below:
Depression |
Stress |
Neurotransmitters |
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