March 31, 2008

Paxil Withdrawal Case Settled in California

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 ( 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