Zoloft Lawsuit – Side Effects & Warnings

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Zoloft (sertraline) is a SSRI antidepressant which is used to treat depression and other mental disorders such as PTSD, OCD and anxiety disorders. A number of Zoloft lawsuits have been filed against Pfizer for side effects and injuries caused by the medication.

Zoloft Lawsuit

Pfizer, the manufacturer of Zoloft, has faced a number of lawsuits in federal, state and local courts throughout the U.S. Lawsuits for Zoloft injuries include multidistrict (MDL) litigation in Pennsylvania where at least 250 claims were filed. Less than 100 of these lawsuits appear to have been settled, mainly regarding Zoloft and birth defects. Other claims have been made against Pfizer for side effects related to Zoloft withdrawal.

Drug Warning: Zoloft

Brand Name Zoloft
Generic Name sertraline
Classification serotonin-specific reuptake inhibitor (SSRI) antidepressant
Manufacturer Pfizer
Dosage form(s) 25mg tablet

50mg tablet

100mg tablet

20mg/ml oral solution

Normal dosage 25 to 100mg daily

Zoloft is an antidepressant prescription medication that is a member of the selective serotonin reuptake inhibitors (SSRIs) category of drugs. It works by increasing levels of the neurotransmitter, serotonin in certain areas of the brain which are involved in mood state and anxiety.

Zoloft is used to treat:

  • Major depressive disorder (MDD)
  • Post-traumatic stress disorder (PTSD)
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder (PD)
  • Social anxiety disorder (SAD)
  • Premenstrual dysphoric disorder (PMDD)

Zoloft Side Effects

Like all medications, Zoloft may cause a number of side effects. Most of these side effects are mild to moderate and may go away with time. Others however may be more severe, long lasting or even serious.

Common side effects of Zoloft include:

  • Headache
  • Nausea and/or vomiting
  • Drowsiness
  • Dizziness
  • Sweating
  • Constipation or diarrhea
  • Malaise or general feeling of unwellness

More severe side effects of Zoloft may include:

  • Hypersensitivity reactions
  • Heart rhythm changes
  • Suicidal thoughts and behaviors
  • Increased risk of bleeding
  • Seizures
  • Serotonin syndrome
  • Discontinuation syndrome
  • Glaucoma
  • Birth defects

Zoloft Warnings

The U.S. Food and Drug Administration (FDA) has required that all antidepressant medications including Zoloft have a black box warning added to the top of all prescribing information. A black box warning or boxed statement warning is the most serious warning that can be issued by the FDA, without withdrawing the medication.

Zoloft’s black box warning indicates that use of Zoloft may increase the risk of suicidal thoughts and behaviors in children and young adults. The black box statement is enclosed in a box with a thick, black border at the top of all prescribing information.

In addition to black box warning regarding suicide, Zoloft may cause other side effects which are serious or life-threatening. These side effects include cardiac effects, serotonin syndrome, withdrawal and the possibility of birth defects.

Zoloft Serotonin Syndrome

Serotonin syndrome is caused by an increase in the amount of serotonin in the brain and body.

It may cause symptoms such as:

  • Agitation or restlessness
  • Confusion
  • Muscle rigidity
  • Loss of muscle control
  • Muscle twitching
  • High fever
  • Heavy sweating
  • Shivering
  • Seizures
  • Irregular heartbeat
  • Loss of consciousness

Symptoms of serotonin syndrome should be reported to a medical health professional immediately. If symptoms occur or worsen rapidly, they should be treated as a medical emergency.

Zoloft Birth Defect

Though it was originally considered safe to use during pregnancy, Zoloft is now considered to be a Pregnancy Category C medication, which indicates that it may cause birth defects and should only be used when medically necessary.

Birth defects related to Zoloft use may include:

  • Heart abnormalities
  • Intestinal disorders (omphalocele, anal atresia, pyloric stenosis)
  • Spina bifida
  • Club foot
  • Cleft lip or palate
  • Persistent Pulmonary Hypertension (PPHT)

Research shows babies born to mothers who have taken Zoloft during pregnancy may be agitated at birth, have difficulty feeding, suffer seizures, and have abnormal muscle tone. Many of the lawsuits filed against Pfizer were due to Zoloft-related birth defects.

Other Zoloft Lawsuits

In addition to side effects that may occur during Zoloft use, some users find that their worst side effects occur when they decide to stop taking the medication. Studies show long-term use of the medication appears to trigger a physical dependency and withdraw symptoms are experienced by those discontinuing their use of the drug. Other Zoloft users and their families have made claims that Zoloft use triggered violent behavior, including suicide. A number of class action lawsuits were also filed in California by Zoloft users who claimed the medicine was ineffective, but no disposition of those lawsuits has been publicized.

Zoloft or sertraline may continue to pose potential risks to patients who take the medication. As such, Zoloft attorneys and lawyers will remain watchful.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

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