Zoloft® Lawyers

Zoloft ® is the Pfizer trade name for Sertraline hydrochloride, a selective serotonin reuptake inhibitor antidepressant used to treat depression, obsessive-compulsive, panic and social anxiety disorders.

The dangers of Zoloft include muscle spasms, flu-like symptoms, difficult speech, severe skin rash, jaundice, irregular heart beat, difficulty breathing and swallowing, blurred vision. Clinical trials have indicated Zoloft causing damage to cardiovascular health and sexual functioning. Common side effects include nausea, weakness, drowsiness, nightmares, dry mouth, skin sensitivity, and appetite changes. Alcohol and the danger of being taken in conjunction with other medications can increases the risk of fatal Zoloft side effects including extreme aggression and hostility, suicidal and homicidal behaviors, drug dependency, and akathisia (extreme anxiety and restlessness).

Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short- term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. Warnings & Precautions Continued Below

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION-Discontinuation of Treatment with ZOLOFT, for a description of the risks of discontinuation of ZOLOFT).

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for ZOLOFT should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that ZOLOFT is not approved for use in treating bipolar depression.

Cases of serious sometimes fatal reactions have been reported in patients receiving ZOLOFT (sertraline hydrochloride), a selective serotonin reuptake inhibitor (SSRI), in combination with a monoamine oxidase inhibitor (MAOI). Symptoms of a drug interaction between an SSRI and an MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued an SSRI and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, ZOLOFT should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should be allowed after stopping ZOLOFT before starting an MAOI.

The concomitant use of Zoloft with MAOIs intended to treat depression is contraindicated (see CONTRAINDICATIONS and WARNINGS - Potential for Interaction with Monoamine Oxidase Inhibitors.)

Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome may occur in treatment with SNRIs and SSRIs, including Zoloft, particularly with concomitant use of serotonergic drugs (including triptans) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

If concomitant treatment of SNRIs and SSRIs, including Zoloft, with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see PRECAUTIONS - DRUG INTERACTIONS).

The concomitant use of SNRIs and SSRIs, including Zoloft, with serotonin precursors (such as tryptophan) is not recommended (see PRECAUTIONS - DRUG INTERACTIONS).

18-year old Libby Zion died as a result of maltreatment by doctors at New York-Cornell Medical Center. Doctors missed the signs of serotonin syndrome from her prescribed antidepressant, Nardill; they prescribed a narcotic (Demerol) which raised the level of circulating serotonin to dangerous levels; their coup de grace was the use of restraints: "When she became agitated, a symptom of serotonin toxicity, and tried to pull out her intravenous tubes, she was restrained, and the resulting muscular tension is believed to have sent her fever soaring to lethal heights." Libby Zion's father, Sidney Zion, a reporter for The Times, sued the hospital.

Zoloft (sertraline hydrochloride)--FDA-Because cases of serious, sometimes fatal, reactions have been reported in patients receiving Zoloft in combination with a monoamine oxidase inhibitor (MAOI), the Zoloft package insert has been revised to contraindicate its use in combination with an MAOI. As has always been recommended, a washout period of at least 14 days should be observed between discontinuing an MAOI and starting Zoloft. Similarly, at least 14 days should pass between stopping Zoloft and starting an MAOI. [August 1, 1995 (letter) - Pfizer, Inc.]

Zoloft® References

• Serotonin Syndrome: A Mix of Medicines That Can Be Lethal
• Levenson M, Holland C. Z"Antidepressants and Suicidality in Adults: Statistical Evaluation. (Presentation at Psychopharmacologic Drugs Advisory Committee; December 13, 2006)". FDA.
• Food and Drug Administration (2007-05-02). "FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications".
• Boseley, Sarah (2003-12-10). "Drugs for depressed children banned". The Guardian.

Zoloft ® Articles

PROTOCOL FOR THE WITHDRAWAL OF SSRI ANTIDEPRESSANTS In the case involving thirteen-year-old Matthew Miller who had hanged himself soon after being prescribed Zoloft, Dr. David Healy testified. Dr. Healy was among the early psychiatrists to detect and report an association between SSRI antidepressants and increased suicidal behavior in some people—children and adults. His educated opinion was based on multiple sources of information including, his research, his clinical observation, and the documentation he had accessed in concealed company documents in the files of Pfizer, Eli Lilly, GlaxoSmithKline, Wyeth, et al.

If you have experienced thoughts of suicide; or suffered the loss from suicide of a family member who was taking Zoloft ® or in withdrawal from Zoloft ®; or were otherwise injured by taking Zoloft ®, you are entitled to compensation. If you or a family member have taken Zoloft ®; and developed problems, you should seek a free consultation regarding your legal rights. Our Zoloft ® lawyers have the experience and resources necessary to obtain compensation from pharmaceutical companies.

Lawsuits have been filed over Zoloft ®. There are indications that e has downplayed the known risks of Zoloft ® usage. If you have experienced complications, you can act now. We can help you get the compensation you deserve.

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