Zoloft Lawsuit

DID YOU TAKE ZOLOFT DURING  YOUR PREGNANCY?

Zoloft Side Effects & Birth Defects

According to a number of studies, the use of the antidepressant Zoloft (Sertraline), manufactured by Pfizer, Inc., and other Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy may lead to a significantly increased risk for one or more serious birth defects among exposed infants. Prenatal exposure to Zoloft has been linked to heart, lung, cranial, abdominal and other serious birth defects.  If you or a loved one has taken Zoloft or another SSRI during pregnancy and gave birth to an infant with severe birth defects, you may be entitled to monetary compensation. For more information about your legal rights, please submit your case for a free, no obligation evaluation of your case.

Side Effects Associated with Zoloft include, but are not limited to the following:

• Heart Birth Defects (atrial or ventricular septal defects (ASD,VSD), tetralogy of fallot (TOF), hypoplastic left heart syndrome (HLHS), transposition of the great arteries (TGA or TOGA), patent ductus arteriosus (PDA), total anomalous pulmonary venous return (TAPVR), double outlet right ventricle (DORV), coarctation of the aorta (CoA)
• Lung Birth defects (persistent pulmonary hypertension (PPHN))
• Abdominal Birth defects (omphalocele)
• Cranial Birth Defects (craniosynostosis)
• Craniofacial Birth Defects (cleft lip and cleft palate)
• Limb Defects (clubfoot)
• Neural-tube defects (spina bifida and anencephaly)

What is Zoloft?

Zoloft belongs to a class of drugs known as Selective Serotonin Reuptake Inhibitors (SSRI) which are used to treat depression, anxiety, and other mood disorders. SSRIs block the reabsorption (reuptake) of the neurotransmitter serotonin in the brain resulting in improvements in the patient’s mood. There are several popular SSRI drugs on the market and taking any one of them during pregnancy may cause severe birth defects. These include Escitalopram (Lexapro), Fluoxetine (Prozac, Prozac Weekly, Sarafem), Paroxetine (Paxil, Paxil CR, Pexeva), Citalopram (Celexa), Fluoxetine combined with the atypical antipsychotic olanzapine (Symbyax).

Zoloft has been approved by the FDA (Food and Drug Administration) to treat patients over 18 years old for Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Panic Disorder, Posttraumatic Stress Disorder (PTSD), Premenstrual Dysphoric Disorder (PMDD), and Social Anxiety Disorder. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).

Zoloft is used to treat:

• Depression
• Obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over)
• Panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks),
• Posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience),
• Social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life).
• It is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness.

Who Should Not Take Zoloft?

Do not take Zoloft in combination with a monoamine oxidase inhibitor (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. Cases of serious sometimes fatal reactions have been reported in patients receiving Zoloft in combination with a MAOI or close in time to an MAOI. These include, but are not limited to the following:

• Hyperthermia (high body temperature)
• Rigidity,
• Myoclonus (involuntary twitching of a muscle or a group of muscles)
• Autonomic instability with possible rapid fluctuations of vital signs
• Mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma.

MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), Selegiline (Emsam) and other brands.

The concomitant use of Zoloft with MAOIs intended to treat depression is contraindicated.

Are There Any Interactions With Drugs or Foods?

Zoloft may interact with other medicines sometimes causing serious side effects.  Tell your healthcare professional about all medicines (prescription and non-prescription), vitamins, and herbal supplements you take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. If you plan on drinking alcohol ask your doctor about the safe use of alcoholic beverages while you are taking Zoloft.

What side effects can this medication cause?

Zoloft may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: nausea, diarrhea, constipation, vomiting, dry mouth, gas or bloating, loss of appetite, weight changes, drowsiness, dizziness, excessive tiredness, headache, pain, burning, or tingling in the hands or feet, nervousness, uncontrollable shaking of a part of the body, sore throat, changes in sex drive or ability, excessive sweating.

Some side effects can be serious. If you experience any of the following symptoms call your doctor immediately: blurred vision, seizures, fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness, abnormal bleeding or bruising, hallucinating (seeing things or hearing voices that do not exist).

This is not an exhaustive list and Zoloft may cause other side effects. Call your doctor immediately if you have any unusual problems while taking this medication.

Zoloft Birth Defect Studies

On July 19, 2006 the FDA issued a Public Health Advisory for Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine, Symbyax (olanzapine and fluoxetine) and Zoloft (sertraline) warning patients and healthcare providers about the increased risk of persistent pulmonary hypertension (PPHN) among infants exposed to SSRIs in utero. The advisory was in response to a study published in the New England Journal of Medicine (NEJM) suggesting a potential connection between SSRI use and PPHN. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.

In 2007, the NEJM published additional studies examining the adverse effects of fetal exposure to SSRI. According to the first study, infants born to women who took an SSRI drug during the first trimester of pregnancy were nearly twice as likely to develop limb reduction defects, club foot and anal atresia. Researchers also found a possible connection between these drugs and cleft palate, cleft lip and neural tube birth defects. The second study indicated that infants whose mothers took an SSRI like Zoloft while pregnant were more than twice as likely to be born with serious  birth defects like anencephaly, craniosynostosis, and omphalocele.

More recent studies have found that taking SSRI’s while pregnant significantly increases the risk of having a child born with congenital heart malformations. A Danish study looked at 216, 042 pregnant women from Denmark. The authors found that the risk of serious heart malformations was more than doubled when a pregnant women, took an SSRI in their first trimester of pregnancy. The risk was even greater with certain types of SSRI’s. For example Zoloft was found to triple the risk of heart malformations. Further a study published in the American Journal of Nursing suggested that infants of women exposed to SSRI antidepressants during the first trimester of pregnancy may be significantly more likely to give birth to infants with serious heart defects, particularly VSDs) and atrial ASDs. According to the study, there was nearly a two-fold increase in the prevalence of septal heart defects among infants exposed to SSRIs when compared to unexposed infants (0.9% and 0.5%, respectively).

Despite these studies, Pfizer, Inc., the manufacturer of Zoloft, has failed miserably to adequately update its drug label to effectively warn patients of the drug’s link to potential serious birth defects. If you or a loved one has been injured by Zoloft please submit your case for a free case evaluation by a professional.