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Paxil, Once Touted as a Top Treatment for Depression, Now Comes with Serious
Warnings of Adverse Side Effects and Withdrawal Symptoms
Antidepressant Paxil hit the marketplace in 1992. It is a member of the class
of antidepressants commonly known as selective serotonin reuptake inhibitors, or
SSRIs. The SSRI drugs revolutionized antidepressants because they have very few
side effects and it is practically impossible to overdose on them.
This explains why Paxil was so commonly used that it came in second only to
Prozac for treating symptoms of depression.
SSRIs like Paxil and Prozac help to circulate more neuro chemicals like
serotonin into the blood stream, which in turn helps the nervous system to
function better, helping to combat the most frustrating symptoms of depression.
Though a latecomer to the SSRI market, Paxil was in high-demand fast after
gaining FDA approval for depression, as well as for very specific conditions
like “social anxiety disorder” and “general anxiety disorder”, which had
received little attention in 1992. In fact, these conditions were practically
unheard of back then.
Recognizing this, Paxil’s manufacturer, Britain-based pharmaceutical giant
GlaxoSmithKline, capitalized on the opportunity and created advertising
campaigns that encouraged people to try their drug if they’d experienced any
general anxiety.
Sales of Paxil soared.
The advertising campaigns also pointed out that Paxil had no side effects and
was not addicting, both of which became major selling points.
Contradictions Abound
However, recent studies have shown that not only can Paxil produce withdrawal
symptoms, but it may be even tougher to stop than other SSRI's because it is so
short acting, meaning the changes made in the body chemistry by Paxil are faster
than other SSRIs.
This is why so many patients using Paxil have found it very difficult to quit.
Even slowly reducing doses and coming off the drug, many patients have
complained of intense stomach pains, diarrhea, intense anxiety, anger,
migraines, and an odd electrical zapping whenever they move their heads or eyes.
In fact, a recent independent study found that as many as 50% of Paxil users
experience intense withdrawal from the drug. While some other drugs in the same
class, like Prozac and Zoloft, cause similar withdrawal reactions none of them
cause reactions this intense.
Paxil Controversy
Considering this, it’s easy to see how GlaxoSmithKline has generated
controversy for allegedly neglecting to warn consumers of the addictive
properties of Paxil. Some allege that they've actually advertised that the drug
is non-habit forming.
Yet, studies have shown that discontinuing or decreasing Paxil can cause many
withdrawal symptoms ranging in severity from mild to extremely dangerous.
Were Patients Misled?
Patients who began taking Paxil based on advertisements that the drug would
not cause dependency feel they have been misled. And, they are not alone. In
June 2004, New York Attorney General Eliot Spitzer filed a lawsuit accusing
GlaxoSmithKline of burying several studies that indicated Paxil was ineffective
in the treatment of children and adolescents and may increase suicidal thoughts.
The lawsuit, filed in New York State Supreme Court, also accuses GlaxoSmithKline
officials of misrepresenting data on the prescribing of Paxil to children.
Trouble for Paxil Manufacturer GlaxoSmithKline
In response to the lawsuit, GlaxoSmithKline published the results of nine
pediatric clinical trials showing Paxil is mostly ineffective in treating
children and may actually increase the risk of suicidal tendencies.
Over the years, the safety of Paxil has been questioned, and Paxil was never
FDA-approved for patients younger than the age 18 because of studies showing it
was not effective.
However, adults using Paxil have filed lawsuits over adverse side effects and
withdrawal problems.
Additionally, GlaxoSmithKline is also facing a number of lawsuits from U.S.
parents of children and adolescents given Paxil after making claims the company
has suppressed data showing the drug increased suicidal tendencies in young
people.
Withdrawal Symptoms Among the Worst
The withdrawal symptoms from Paxil, according to the World Health
Organization, are much more severe than first thought and may even plunge users
into the depths of depression due to the increase of serotonin and decrease of
serotonin metabolism that it produces.
Because of this, a California lawsuit against GlaxoSmithKline charged the drug
company with failing to warn the public about the dangers of Paxil withdrawal.
GlaxoSmithKline reportedly resolved the suit in January 2002.
The suit charged that Paxil causes serious withdrawal problems of many kinds,
resulting in a widespread societal problem when many individuals find themselves
unable to stop taking the drug.
On December 14, 2001, during the Paxil withdrawal lawsuit, GlaxoSmithKline
finally updated its label for Paxil with a specific mention of the danger of
Paxil withdrawal reactions.
The Bottom-Line
It is now generally recognized that SSRIs, including Paxil, can cause a
condition called akathisia (severe inner restlessness) that is associated with
suicidal tendencies. In Diagnostic and Statistical Manual of Mental Disorders,
Fourth Edition, Text Revision ("DSM IV TR") under Differential Diagnosis it
states: "Serotonin-specific reuptake inhibitor antidepressant medications may
produce akathisia . . ." "Akathisia may be associated with dysphoria
(restlessness, depression & anxiety), irritability, aggression, or suicide
attempts."
In October 2003, the FDA notified healthcare professionals of reports of the
occurrence of suicidal tendencies (both suicidal ideation and suicide attempts)
in clinical trials for various antidepressant drugs in pediatric patients with
major depressive disorder.
Then, in March 2004, the FDA issued a Public Health Advisory that provides
further cautions to physicians, their patients, and families and caregivers of
patients about the need to closely monitor both adults and children with
depression, especially at the beginning of treatment, or when the doses are
changed with either an increase or decrease in amount.
Shortly after the release of the Public Health Advisory, the FDA and
GlaxoSmithKline notified healthcare professionals of revisions to the warnings
and precautions of Paxil labeling to alert healthcare professionals that
patients with major depressive disorder may experience worsening of their
depression and/or the emergence of suicidal ideation and behavior (suicidal
tendencies), whether or not they are taking antidepressant medications.
Sources
Hawkins, Beth. “Paxil is Forever.” City Pages 16 Oct. 2002. 2 March 2007
<http://citypages.com/databank/23/1141/article10788.asp>.
Also see: [
antidepressants ] [
natural remedies for
depression ] [
depression help ]
About the Author:
Kellie Fowler is an award-winning
writer and has written for Associated Press, PR Newswire, Fortune 500 companies,
newspapers, national business and healthcare magazines. She is a regular
contributor to www.depression-help-resource.com, a website providing
easy-to-understand depression information, articles and resources. |
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