Paxil Withdrawal Case Settled in California
A California lawsuit against Glaxo SmithKline
(GSK) charged the drug company with failing to warn the public about the
dangers of Paxil withdrawal. Glaxo SmithKline (GSK), the manufacturer
of the antidepressant Paxil, resolved the suit in January 2002. The
results of the resolution, including any settlement by defendant Glaxo SmithKline,
were not announced. The outcome was described as a resolution rather
than a settlement.
Psychiatrist Peter Breggin, M.D. was the plaintiff's
medical expert and worked closely with the attorneys in formulating the
suit. According to Dr. Breggin, there is published and clinical evidence
that all of the SSRIs can cause serious withdrawal reactions. Paxil,
because of its intense impact and short duration of action, causes the most
severe withdrawal reactions.
Paxil is an antidepressant of the SSRI class that
also includes Prozac, Zoloft, Celexa and Luvox. 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.
The Paxil withdrawal suit was brought in San Jose,
California on August 19, 2000 as a "Complaint for Injunctive Relief Under
Business and Professions Code" (Nguyen & Farber, plaintiffs vs. SmithKline
Beecham Corporation, Case No: CV791998).
Legal brief for the resolved Paxil withdrawal suit
GSK Updates the Paxil Label
In December, in an event that may have been in
part motivated by the Paxil withdrawal suit, GSK finally updated its label
for Paxil with a specific mention of the danger of Paxil withdrawal reactions.
One of the attorneys who filed the suit, Don Farber of San Rafael, California,
told Dr. Breggin that it is highly likely that the suit influenced both the
drug company and the FDA to strengthen the label in regard to Paxil withdrawal
effects. Farber and his colleague Vince Nguyen voluntarily dismissed
the suit when the new label was issued on December 14, 2001.
The revised label uses the industry-favored term "discontinuation"
instead of withdrawal. Discontinuation is a euphemism for withdrawal
that is used to circumvent the negative connotations associated with addiction,
dependency and withdrawal syndrome. By using the term discontinuation
instead of withdrawal, the drug company obscures the potential severity of
these symptoms and their tendency to force patients to continue taking the
drug.
The updated label can be found on the company website
(www.GSK.com under Products).
In the Precautions section of the new label, GSK cites clinical trial data
confirming the existence of several withdrawal symptoms, including abnormal
dreams, paresthesia [abnormal sensations], and dizziness. According
to the label, since the marketing of Paxil, other withdrawal symptoms have
been reported in association with the discontinuation of the drug. These
post-marketing reports include "dizziness, sensory disturbances (e.g., paresthesias
such as electric shock sensations), agitation, anxiety, nausea and sweating."
However, the company claims that the reactions reported since the start of
marketing "may have no causal relationship to the drug" and are "generally
self-limiting."
Dr. Breggin stressed the importance of the "anxiety"
and "agitation" mentioned in the label as reported in association with Paxil
withdrawal. He observed that anxiety and agitation can contribute to
aggressive, violent or suicidal behavior. Aggressive behavior is especially
likely to result when a drug causes or increases agitation and anxiety in
individuals already suffering from psychiatric disorders such as anxiety,
depression, panic, stress, and obsessions or compulsions. Dr. Breggin
also stated that there is a growing body of clinical and research literature
demonstrating irritability and aggression during withdrawal from Paxil.
However, the updated label makes no mention of any danger of aggressive, violent
or suicidal behavior during Paxil withdrawal.
Dr. Breggin was gratified to see the company update
its label to specifically mention withdrawal reactions. However, he
described the updated label as grossly inadequate in regard to the range,
intensity and persistence of Paxil withdrawal reactions, including the danger
of aggressive, violent, or suicidal behavior, and an overall worsening of
the patient's mental condition.
Longstanding Concerns About SSRI Withdrawal Effects
Dr. Breggin was among the first to warn about the
dangers of SSRI withdrawal in his book
Talking Back to Prozac
(with Ginger Breggin, St. Martin's Press, 1994) and in two more recent books,
Brain-Disabling
Treatments in Psychiatry
(Springer Publishing Company, 1997, revised 2008) and
The Antidepressant Fact Book
(Perseus Books, 2001). Dr. Breggin and co-author David Cohen,
Ph.D. also discuss the overall problem of drug withdrawal in
Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medications
(Perseus Books, 1999, revised 2007). These books should be consulted
for documentation and further discussion of the issues surrounding the SSRI
antidepressants such as Paxil, Prozac, Zoloft, Celexa and Luvox.
Dr. Breggin is currently a medical expert in other
cases related to Paxil withdrawal. In a criminal case, a young
man physically assaulted a female friend while he was undergoing withdrawal
from Paxil. The young man had no previous history of violence.
The assault was extremely out of character.
Dr. Breggin is also actively involved in treating
patients who have experienced serious difficulty withdrawing from Paxil
and other SSRI antidepressants. Headaches, nausea, dizziness, painful internal
sensations, and various manifestations of emotional distress can make it
difficult to withdraw from these medications. Some patients experience
very lengthy withdrawal periods lasting several months or more.
Direct Toxic Effects Caused by SSRIs
In 1994 Dr. Breggin developed and provided the
scientific basis for a large series of combined product liability cases alleging
violence and suicide caused by Prozac. The court combined the cases
in order to facilitate the discovery process. It facilitated one organized
effort for evaluating secret materials obtained from the company. In
his role as the medical expert for the combined cases, Dr. Breggin reviewed
internal documents from Eli Lilly & Company, the manufacturer of Prozac,
and also interviewed FDA officials, examined FDA materials, and reviewed
and analyzed the scientific literature. In a more recent suit product
liability suit against Eli Lilly & Company, Dr. Breggin once again had
the opportunity to examine internal documents, this time at the corporate
headquarters. As far as Dr. Breggin is aware, all of the individual
Prozac product liability suits in which he has agreed to be an expert have
been settled or remain active.
Background Science
SSRI's including Prozac, Paxil, Zoloft, Luvox and
Celexa block the removal of serotonin from the synapse or space between neurons.
Other antidepressants, such as Effexor, can also block this reuptake of serotonin
causing similar effects. These drugs can cause suicide, violence and
other criminal acts through several mechanisms, including the following:
(1) SSRI-induced mania, sometimes (but not always)
with psychotic features, such as hallucinations or delusions. During
drug-induced mania, the individual can make elaborate plans, including robberies
or embezzlement. However, the plans are often outlandish and doomed
to failure due to obviously poor judgment. Drug-induced mania can cause
many expressions of disinhibited or out-of-control behavior, including sexual
acting out, road rage, buying sprees and shoplifting. Drug-induced mania,
even when seemingly not intense, can ruin marriages and destroy careers.
All of the features of mania are not required in
order to meet the diagnosis of Antidepressant-Induced Mood Disorder with Manic
Features. If the individual's mood is "elevated, euphoric, or
irritable," the necessary criteria are met.
(2) SSRI-induced depression or worsening of depression.
In a seemingly paradoxical effect, antidepressants can cause or worsen depression.
In controlled clinical trials for Prozac that were conducted by the manufacturer,
Eli Lilly and Company, depressed patients taking Prozac attempted suicide
more frequently than depressed patients taking placebo (sugar pill) or older
antidepressants.
(3) SSRI-induced severe anxiety and agitation,
especially in a patient already suffering from depression with anxiety and
agitation;
(4) SSRI-induced obsessions and compulsions that
motivate violence toward oneself or others.
(5) SSRI-induced akathisia, an internal sensation
of agitation or discomfort that drives a person to move about, and also
to lose impulse control. During akathisia, the inner experience of
agitation includes many unusual physical feelings, such as electricity in
the head or body. The person suffering from akathisia typically
feels compelled to move the feet when sitting, to stand, or to pace.
Akathisia is known to increase the risk of suicide and violence.
Severe Adverse Effects After One or Two Doses
Dr. Breggin stated that physicians and patients
are not aware that many severe adverse drug effects can surface after the
first or second dose of any SSRI antidepressant. Because the "therapeutic
effect" of any antidepressant usually takes several weeks or more to develop,
some doctors fail to realize that toxic effects can develop beginning with
the first dose. These doctors are not likely to warn patients and
their families about adverse events occurring after one or two doses.
Furthermore, these doctors may discount the patient's report when these early
reactions occur. They may urge the patient to continue taking the drug
so that the patient ends up developing an unnecessarily severe reaction.
Dr. Breggin is a medical expert in cases in which
SSRI antidepressants, including Prozac, Paxil, Zoloft, Celexa and Luvox, have
caused suicidal and violent behavior in individuals while taking the drug
rather than during withdrawal. In some cases, it can be difficult to
determine if the adverse drug effect is caused by direct drug toxicity, by
drug withdrawal, or by both.
Dr. Breggin is also involved in a variety of other
suits relating to harmful effects of the SSRIs. This website
contains additional relevant materials, including >discussions of other lawsuits,
and details about how the SSRI antidepressants can cause mania, psychosis,
depression, violence, and suicide.
Brief filed in Paxil withdrawal suit
