Published on:

Paxil

The antidepressant medication attorneys at the Drug Law Center are currently accepting cases involving patients who suffered harm after taking the selective serotonin reuptake inhibitor drug.

What is Paxil?

Paxil (paroxetine) RecallsPaxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) prescribed by doctors for the treatment of anxiety disorders, depression, premenstrual dysphoric disorder (PMDD), and obsessive-compulsive disorder (OCD). The FDA first approved the psychotropic medication in 1992 is administered orally in numerous dosage strengths. Some doctors prescribed Paxil (paroxetine) to enhance high levels of neuroticism, the negative emotions associated with self-consciousness, impulsivity, hostility, anxiety, and stress.

Even though the medication has been found highly successful at relieving anxiety and depression symptoms it can cause significant sexual side effects including reduced libido (diminished sexual drive) and the inability to ejaculate or complete orgasm. Many patients find that taking Paxil minimizes insomnia symptoms. However, it is also known to increase the potential risk of suicidal ideation, especially in individuals 24 years old or younger. The medication is effective because it increases the brain serotonin level and activity that regulates mood.

Who Should Avoid Taking Paxil?

Some patients taking selective serotonin reuptake inhibitors (SSRIs) might experience serious life-threatening adverse reactions or severe side effects and should avoid taking the drug altogether. Patients with any of the following should have a discussion with the doctor to determine if the medication is right for them. Includes:

  • Bleeding from the duodenum, esophagus, or stomach
  • Suicidal ideation (thoughts of suicide)
  • Liver problems
  • Low blood sodium levels
  • Antidiuretic hormone secretion syndrome
  • High restlessness and anxiety levels
  • Pregnancy
  • Closed-angle glaucoma
  • Renal impairment
  • Seizures
  • Bleeding risk
  • Elderly or debilitated patients
  • Adverse Drug Interaction Serotonin Syndrome
  • Manic-depression

Paxil Side Effects

Like every prescription drug, Paxil (paroxetine) causes mild to severe side effects in different individuals. The most common mild Paxil side effects include:

  • Drowsiness, dizziness, weakness, and vision changes
  • Constipation
  • Insomnia (difficulty in sleeping)
  • Shaking and sweating
  • Anxiety
  • Dry mouth
  • Diminished libido
  • Impotence

Paxil and Birth Defects

A direct correlation has been identified between taking Paxil (paroxetine) and the development of birth defects when the fetus is in the womb. Studies have indicated that pregnant mothers taking the antidepressant medication within the early stages their pregnancy are at greater risk of giving birth to babies with the facts. While the percentage remains relatively low (one percent to three percent) of defects occurring in all pregnancies, studies of indicated that the antidepressant medication used during the first trimester increases the potential risk upwards to 23 percent risk of the baby developing a major congenital malformation and almost 28 percent of developing a heart defect.

In addition, studies involving animals taking the medication have revealed that exposure to Paxil, paroxetine, or other antidepressant medication could increase the risk of having a miscarriage. Some studies indicate that mothers who took the antidepressant medication throughout their entire pregnancy had babies who experience withdrawal symptoms after birth. Typically, these babies displayed signs of irritability, jitteriness, tremors, altered sleep patterns, increased muscle tone, difficulty in breathing, and challenges when eating.

Researchers have concluded that small amounts of the antidepressant medication can pass through the mother’s breast milk during feeding. However, breastfed implants in the study showed no adverse effects, but, no long-term studies involving breastfed babies exposed paroxetine has been conducted.

The FDA (Food and Drug Administration) issued an alert in July 2016 showing that “a recently published case -controlled study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the twentieth week of pregnancy were six times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

The National Birth Defects Prevention Study of Infants released data on the correlation of taking Paxil antidepressant medications in the development of two different kinds of congenital abnormalities including craniosynostosis and omphalocele. The congenital defect craniosynostosis affects the infants had sutures to close sooner than normal. The early closing often forms an abnormally shaped skull. Congenital defects omphalocele affects the newborn’s abdominal wall at the umbilicus (umbilical cord) where a sac protrudes through the baby’s abdominal wall containing the large intestine, liver, and small intestine.

Paxil and Suicide Ideation

In June 2008, the FDA released prescribing information on taking Paxil (paroxetine hydrochloride) through oral suspension and tablets. The release noted the suicidality of antidepressant medications stating that:

“Antidepressants increase the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil or any other antidepressant in a child, adolescents, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressant compared to placebo in adults beyond age 24.”

In August 2003, the FDA issued a warning of the “Potential for interaction with monoamine oxidase inhibitors [MAOI]: In patients receiving another serotonin reuptake inhibitor drug in combination with a monoamine oxidase inhibitor (MAOIs), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus [small jerky muscle contractions], autonomic instability with rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.”

Paxil and the FDA

In addition to forcing GlaxoSmithKline to update its black box warning labels to include information on the increased potential suicidal ideation, the FDA (Food and Drug Administration) in 2005, issued a public health advisory. The document warned physicians and patients of the potential increase of developing birth defects when taking Paxil (paroxetine). The safety advisory document alerted consumers and prescribing doctors about heart defect concerns caused by the medication along with other serious side effects that include:

  • Cranial defects
  • Clubfoot
  • Malformations
  • Cleft palate and/or cleft lip
  • Abdominal defect
  • Spina bifida
  • PPHN (persistent pulmonary hypertension of the newborn)

Antidepressant Suicide Lawsuits

In 2001, the first Paxil suicide lawsuit went to trial in Cheyenne, Wyoming. The case involved an adult individual who prior to taking his own line killed his wife, daughter, and granddaughter. The family’s attorney at seven the patient was taking the medication two days before the incident occurred. The case involved the drug maker GlaxoSmithKline that paid the $8 million award in June of that year.

It was hardly the first lawsuit filed against antidepressants causing suicide. Six years later in April 2007, Public Citizen a consumer advocate watchdog, played a significant part in the nearly $64 million class action lawsuit settlement against the drug manufacturer. The case involved the company’s failure to warn consumers about the potentially dangerous side effects of prescribing Paxil to children 17 years old and younger.

The pharmaceutical giant agreed to a $40 million class action settlement in 2008. The documents alleged that the drug was ineffective and could cause the increase of suicidal ideation (thoughts) and suicidality (action) in young children.

The jury in the landmark 2009 lawsuit trial awarded more than $2.5 million in compensatory damages to the plaintiff. Lawsuit documents alleged that GlaxoSmithKline was responsible for the birth defects associated with the plaintiff. That same year, the pharmaceutical giant negotiated financial settlements to settle hundreds of other lawsuits across the United States. The following year in July 2010, GSK agreed to settle approximately 800 lawsuit cases with payments averaging $1.2 million per case.

Paxil Individual Lawsuits

Patients injured by bad pharmaceutical medications are often faced with years of rehabilitation, ongoing medical bills, days away from work, or wrongful death of a loved one whose life was taken much too soon because of a bad drug. In an effort to maintain the family’s financial stability, these injured parties will file a wrongful death lawsuit or product liability injury claim against the pharmaceutical giant who designed, manufactured, marketed, promoted, distributed and sold the drug to consumers. Two Paxil individually filed lawsuits involving child birth defects in the company’s failure to warn consumers include:

  • Child Permanently Harmed by Paxil Side Effects
    October 2013 – GlaxoSmithKline is facing another Paxil side effect injury lawsuit, this time filed by a plaintiff claiming that her son’s congenital heart defects were allegedly caused by her taking Paxil while she was pregnant. The plaintiff is making claims that her taking SSRI antidepressant medication and her son’s congenital coarctation of the aorta and ventricular septal defect are connected.Lawyers working on her behalf have alleged that GlaxoSmithKline, the Paxil drug maker, was aware, or should have been aware, of the known side effects caused by the medication. The attorneys are claiming that the company failed to warn consumers that taking the antidepressant drug during pregnancy could cause birth defects. This case was filed in the U.S. District Court for the Eastern District of Pennsylvania.

 

  • Infant Wrongful Death Lawsuit Filed against Antidepressant Drug Makers
    November 2012 – An antidepressant wrongful death lawsuit was filed on behalf of the parents of a deceased girl who died because of birth defects, allegedly because her mother took SSRI antidepressants while she was pregnant. Lawsuit documents reveal that the mother allegedly took Zoloft and Paxil during pregnancy. Because of that, her little girl was born with heart birth defects including ventricle and atrial septal defects that ultimately resulted in the child’s death.Attorneys working on behalf of the mother claim that SSRI (serotonin reuptake inhibitor) antidepressant medications are marketed and sold as effective treatments for depression. The drug makers claim that the increase levels of serotonin help the individual achieve a healthier mental balance. However, the attorneys claim that the pharmaceutical giant was aware, or should have been aware of the potentially serious side effects including birth defect development and instead chose to warn consumers of the potentially deadly side effects. This case was filed in the U.S. District Court, Eastern District of Pennsylvania.

How a Paxil Injury Attorney Can Help

The antipsychotic medication injury attorneys at the Drug Law Center are now available to assist clients in filing pharmaceutical defect litigation. Contact us today to schedule a free consultation to determine if you have a strong case. Allow our law firm to handle every aspect of your recompense claim. We offer a “no win/no fee” guarantee meaning we are paid only for the cases we win, so no upfront fee is necessary.

If you hire us to handle your case, we can assist you in gathering pertinent evidence and provide resources to help expose the negligence of GlaxoSmithKline in developing, marketing and selling their defective medication. With our years of experience, are negotiated settlements and jury awards tend to be significantly higher in financial compensation that had the plaintiff handled the case on their own.

If you believe you have suffered serious injury or your child was born with a defect after you took Paxil, paroxetine, or other SSRI antidepressant medication, we can provide you various legal options on how to proceed. We are successful at resolving medical malpractice, wrongful death, personal injury, and product liability lawsuits.

Sources:

https://www.fda.gov/ohrms/dockets/ac/04/briefing/4021b1_07_paroxetine%20label.pdf

http://www.nbdps.org/research/recentfindings.html

https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm085313.htm