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Zoloft

The Zoloft injury case attorneys at the Drug Law Center represent clients who have suffered serious harm or died prematurely after taking the SSRI antidepressant medication.

Introduction

Zoloft Drug RecallZoloft (sertraline) is an SSRI (selective serotonin reuptake inhibitor) antidepressant medication. The prescription drug is used to treat depression, anxiety disorder, panic disorder, OSB (obsessive compulsive disorder), PMDD (pre-menstrual dysphoric disorder), and PTSD (post-traumatic stress disorder). The Food and Drug Administration has not approved Zoloft for use in children, except pediatric patients suffering from obsessive-compulsive disorder.

The History of Zoloft

The precursor psychoactive compound chemical makeup of what would eventually become Zoloft was first synthesized in the early 1970s by Pfizer employee Reinhard Sarges. By the late 1970s, two other Pfizer employees, Willard Welch and Kenneth Koe took the synthesized version of the psychotropic medication and experimented with the drug to discover a serotonin reuptake inhibitor that eventually would become Zoloft (sertraline).

In 1991, the Food and Drug Administration officially approved sertraline. By 2002, the brand-name Zoloft received its FDA approval for use in teenagers and children 17 years and younger to treat OCD (obsessive-compulsive disorder). Three years later in 2005, the FDA mandated that the makers of Zoloft revise its warning label to provide information to consumers concerning the potential risks of suicidal ideation and behavior in children. In 2007, the FDA required Pfizer to revise its warning label again to notify the public and doctors of suicidal behavior occurring in patients taking Zoloft who were age 24 years and younger.

Zoloft Side Effects

Every prescription medication and over-the-counter drug has some form of side effects or adverse reactions. Zoloft is no exception. The most common less serious side effects in patients taking Zoloft or the generic version sertraline include:

  • Dizziness
  • Drowsiness
  • Insomnia (difficulty in sleeping)
  • Unexpected change in weight or appetite
  • Dry mouth
  • Upset Stomach
  • Abdominal or stomach cramps, pain, or gas
  • Constipation
  • Painful, burning or difficult urination
  • Cloudy your
  • Unexpected change in vision
  • Tenderness or pain on the cheekbones or around the eyes
  • Upset stomach, stomach pain, and/or mild nausea
  • Impotence
  • Decreased libido (diminished sex drive)
  • Difficulty achieving orgasm

Usually, many of the side effects experienced by patients taking Zoloft will fade away in a couple or few weeks. Sometimes, the patient will have lasting withdrawal symptoms the tend to hang on for many months after the medication was taken.

Allergic Reactions

Some people are allergic to the active and inactive ingredients in Zoloft (sertraline) that often requires emergency medical attention. Common signs the patient is suffering allergic reaction includes a display of hives or skin rash, swelling of the throat, tongue, lips, or face, and difficulty in breathing. It is crucial to seek immediate medical attention or talk with the doctor if any of the symptoms worsened. These symptoms include:

  • Unexpected changes in behavior mood
  • Panic attacks
  • Anxiety
  • Difficulty in sleeping
  • Hyperactivity (physically or mentally)
  • Restlessness
  • Aggressive reactions
  • Hostile behavior
  • Feeling agitated, irritable, or impulsive
  • Deepening depression
  • Inability to sit still
  • Sudden or unusual facial or body movements
  • Shivering
  • Nosebleeds
  • Joint pain
  • Loss of bowels or bladder control
  • Suicidal ideation (thinking about committing suicide or causing self-harm)
  • Hallucinations
  • Agitation
  • Tremors
  • Overactive reflexes
  • Fever
  • Sweating
  • Very rigid (stiff) muscles
  • Uneven or fast heartbeat
  • Memory problems
  • Seizures
  • Painting
  • Shallow breathing

Who Should Avoid Taking Zoloft?

Zoloft, like many prescription medications, has contraindications, where some individual should avoid taking the drug altogether. This is because antidepressant affects chemicals in the brain, especially serotonin when the drug is stopped suddenly. Typically, the body responds by displaying emotional and physical symptoms due to the sudden absence of high levels of serotonin in the body.

While not technically a withdrawal (Zoloft is not habit-forming or addictive) the medication can mimic psychological consequences of withdrawing from an addictive medication. The most common contraindications involving taking Zoloft include:

  • Taking Zoloft concomitantly with MAOIs (monoamine oxidase inhibitor) including intravenous methylene blue and linezolid.
  • Taking pimozide
  • Suffering with:
    • Liver problems
    • Serotonin syndrome – adverse drug interactions
    • Suicidal ideation
    • Manic-depression
    • Increase risks of bleeding
    • Mild mania
    • Low bloodstream sodium levels
    • Weight-loss
    • Seizures
    • Bleeding from the esophagus, duodenum, or stomach

Zoloft Withdrawal Symptoms

Physicians are to warn their patients taking Zoloft to avoid putting the antidepressant suddenly and instead withdraw from the medication and according to the instructions from the doctor. Typically, patients suffering discontinuation symptoms after withdrawing from the antidepressant will develop noticeable indicators, where sudden withdrawal could produce undesirable symptoms within the first one or 2 days that include:

  • Flu like symptoms
  • Nausea
  • Anxiety
  • Nightmare
  • Insomnia
  • Irritability

To minimize the potential of experiencing withdrawal symptoms, the dose of the medication should be tapered down gradually while under the supervision of a doctor or healthcare provider. This will help alleviate many of the common symptoms or at least minimize most of them. Even so, it is still possible to experience serious withdrawal symptoms even though the dosage to the drug has been tapered slowly.

Zoloft and Birth Defects

The Food and Drug Administration has classified Zoloft, and other antidepressant medications, as a “Category C” drug. This means the medicine is likely been tested on animals, not yet tested on humans. A Category C Classification helps notify pregnant women and women of childbearing age that there may be potential risks to taking the drug.

To date, Zoloft researchers have concluded after an extensive study in rabbits and rats provided 4 times the highest recommended a dosage of Zoloft showed fetuses with diminished bone growth. In addition, the rate of stillborn offspring rose significantly in animal testing as did the number of deaths occurring to newborns four days old or younger.

No formal studies on birth defects have been performed on Zoloft, the popular anti-depressive medication. However, many women who were prescribed Zoloft while they were pregnant reported their children had experienced birth defects likely caused by brand-name Zoloft, and/or its generic version sertraline.

The women formally reporting that their newborns suffered birth defects listed their conditions as having seizures, apnea, cyanosis, respiratory distress, tremors, hypoglycemia, constant crying, and difficulty in feeding. One study revealed that when children were exposed to Zoloft, or other SSRIs (selective serotonin reuptake inhibitors), during the mother’s final trimester showed an increased potential risk of developing persistent pulmonary hypertension and possibly death.

Zoloft Lawsuits

Many individuals and family members have filed Zoloft lawsuits against Pfizer for the damage their medication has caused. Some of these lawsuits involve:

  • Zoloft Lawsuit Claims Harbor Defect Might Be Caused by the MedicationJanuary 2015 – Pfizer is facing another Zoloft birth defect lawsuit, this time filed by a Florida plaintiff claiming the SSRIs (selective serotonin reuptake inhibitors) antidepressant medication was the direct cause of her newborn developing a birth defect. The plaintiff accuses Pfizer of failing to adequately test the medication and allowing doctors to continually prescribe the defective antidepressant to pregnant women without giving them adequate warning of the potential birth defects that can occur.Lawsuit documents reveal that the plaintiff and her newborn suffered an emotional and physical injury that was likely caused by Zoloft. The child needs continuous medical care, exams, and testing. The mother is claiming that the child will be “deprived of living a normal childhood.”
  • Other Plaintiffs Joined Pfizer’s Mass Birth Defect Tort LawsuitNovember 2014 – Pfizer is facing a Zoloft birth defect lawsuit by the family of a child that was born with serious birth defects. The young daughter’s parents serve as the lawsuit’s plaintiffs claiming that the little girl was born with severe birth defects after the mother had taken Zoloft throughout her pregnancy on her doctor’s orders.Lawsuit documents reveal that the young newborn was born with a widespread deformity to the skeleton, congenital dislocation (missing dislocated bones at birth) throughout her entire body. The newborn also had a cleft palate and cleft lip that will require extensive medical treatment in the years ahead.The plaintiffs in the case are not alone. Thousands of other families have filed Zoloft birth defect lawsuits in state and federal courthouses. Some of these cases have been grouped together for MDL (multidistrict litigation).
  • Heart Defect Likely Caused by Antidepressant Medication
  • A Zoloft lawsuit has been filed by a Louisiana mother against the drug maker Pfizer, Inc. The plaintiff has alleged that taking Zoloft during her pregnancy led to her son being born with a life-threatening heart defect. Lawsuit documents reveal that the plaintiff’s doctor prescribed Zoloft as an effective solution for treating an undisclosed medical condition. However, the woman was pregnant at the time. The plaintiff claims that she and her doctor were not made aware that taking Zoloft could produce expected congenital birth defects if the meds were used during pregnancy.
    • The plaintiff claims that had she been made aware, she likely would have chosen other treatments and not taken Zoloft at all. The basis of the lawsuit says that “
    • Pfizer was aware or should have been aware, that their popular antidepressant medication had the potential of causing congenital birth defects and chose to keep the information from doctors, the medical community, consumers, and patients.
    • The warnings that Pfizer provided on Zoloft packaging were inadequate and failed to mention the potential risks the fetus was exposed to at the mother was taking the drug during pregnancy.
    • Pfizer pulled failed to pull the medication from the medical marketplace and also failed to revise warnings on the black box label. Because of that, Pfizer failed to take corrective action and still continues marketing Zoloft as both effective and safe.
    • Pfizer was aware or should have been aware that Zoloft (sertraline) can easily cross the placenta and do damage including developing congenital birth defects while the mother taking the drug is pregnant.

Let Us Handle Your Zoloft Lawsuit

Our Zoloft lawsuit lawyers are investigating, evaluating, and pursuing claims against Pfizer, the maker of Zoloft, for their failure to notify patients of the potentially severe side effects the drug can cause. The side effects include an increased potential risk of suicidal ideation (thinking of suicide), serotonin syndrome, and birth defects.

If you have suffered a serious injury, or lost a loved one, after taking Zoloft, it is crucial to start your antidepressant lawsuit now. Contact us today. We offer no obligation, complimentary case consultations. Our team of dedicated attorneys can answer every question you have involving pursuing a claim for compensation against Pfizer and others.

Our lawyers to work on your behalf to ensure that your rights are protected. We are currently accepting all antidepressant medication injury cases through contingency fee agreements. This means we will postpone all our fees and until after we have successfully resolved your case through a negotiated settlement out of court, or from a jury award at the end of trial. All information you share with our law offices will always remain confidential.

 

Sources:

http://jamanetwork.com/journals/jama/fullarticle/188200

https://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm126522.htm

https://www.fda.gov/ohrms/dockets/ac/04/briefing/4006b1_06_zoloft-label.pdf

https://my.clevelandclinic.org/health/articles/obsessive-compulsive-disorder

https://my.clevelandclinic.org/health/articles/the-use-of-medications-in-the-treatment-of-depression

http://www.mayoclinic.org/drugs-supplements/sertraline-oral-route/description/drg-20065940