Since Paxil’s release to the U.S. market, approximately 5,000 Americans filed Paxil lawsuits against GlaxoSmithKline (GSK). Paxil is one of several selective serotonin reuptake inhibitors (SSRIs) intended to treat depression. However, the drug was also prescribed to pregnant women with anxiety. The drug is associated with causing severe birth defects, as well as causing its users to have extreme suicidal thoughts. Millions of women unknowingly took the drug early on in pregnancy. There are several studies confirming the link between Paxil and birth defects. GSK has spent millions of dollars in lawsuit settlements. If you or an expectant mother in your life gave birth to a child with birth defects, contact a Carlson Law Firm Paxil Birth Defects lawyer to discuss your case. A Paxil Lawsuit may be the answer you’re looking for.
Paxil birth defects are extremely costly. You should know that you and your child have rights. Our firm has more than 40 years of experiencing fighting for justice on behalf of victims of dangerous drugs. Contact The Carlson Law Firm to discuss your Paxil lawsuit options if your child was born with birth defects after taking Paxil during pregnancy.
Call us today to schedule a free consultation with Paxil birth defects lawyer.
What is an SSRI?
Paxil, Zoloft and Prozac are SSRIs (Selective serotonin reuptake inhibitor) or “antidepressant” drug prescribed to patients living with depression, anxiety and personality disorders. Paxil is one particular brand name for the drug paroxetine. Out of all the SSRIs, Paxil and other paroxetine drugs are known for being some of the most potent.
Paxil first entered the medical market in 1992 and by 2007 it was the fifth most commonly prescribed SSRI in the nation. Many people who took Paxil experienced side effects much more severe than they were warned about. If you took Paxil and experienced a severe side effect, you may be entitled to take legal action. A Paxil birth defects lawyer at The Carlson Law Firm is here to help.
How does An SSRI Work?
Serotonin is a naturally occurring neurotransmitter chemical in the body that contributes to feelings of happiness and well-being. Paxil and other SSRIs increase the levels of serotonin in the body. When SSRIs work as intended, higher levels of serotonin help ease the sadness and hopelessness in patients with depression.
What are the Serious Side Effects of an SSRI?
Many people who take or have taken an SSRI experience serious side effects. While the warning label on the drug states that the most common symptoms are things like nausea, insomnia, headache, irritability, etc. some who took the drug experienced side effects that are much worse. The risk of birth defects in pregnant women and suicide or severe suicidal thoughts are two of the most serious side effects of the drug. In addition, there have been studies suggesting that exposure to medication slightly increases the risk for miscarriage.
In addition to birth risks, there are several side effects associated with taking Paxil. The side effects range from mild to very severe. SSRI side effects include, but are not limited:
- Profuse sweating
- Weight loss
- Traumatic bone fractures
- Temporary and painful muscle paralysis
Paxil’s side effects can be extremely dangerous. Patients report experiencing violent outbursts and suicidal thoughts and tendencies. These serious side effects can occur even after taking the drug for a few days, or within days of a dosage increase. If your child or the child of a loved one was born with Paxil-related birth defects, contact The Carlson Law Firm. We have a Paxil birth defects lawyer who can help you navigate a Paxil lawsuit. You may seek compensation from GSK for damages your child incurred as a result of this dangerous medication.
Which SSRIs are approved to treat depression?
The FDA has approved several SSRIs to treat depression:
- Citalopram (Celexa)
- Escitalopram (Lexapro)
- Fluoxetine (Prozac)
- Paroxetine (Paxil, Pexeva)
- Sertraline (Zoloft)
- Vilazodone (Viibryd)
Fluvoxamine, an SSRI that’s approved by the FDA to treat obsessive-compulsive disorder, is sometimes used to treat depression.
Depression Treatment During Pregnancy
One out of 10 American take medication for depression. Currently, Paxil is the fourth most commonly prescribed drug to treat mental ailments such as depression and obsessive-compulsive disorder (OCD). A large portion of those suffering from depression is expectant mothers. In fact, studies suggest that the prevalence of major depression disorder (MDD) affects about 15 percent of women during pregnancy. This is a difficult place to be in. Studies suggest that untreated depression and exposure to SSRIs during pregnancy can both alter fetal development and health.
Left untreated, depression can lead to serious issues such as miscarriage, heightened risks of suicide and emotional instability in children during childhood through adulthood. However, women who opt to follow a doctor’s advice and take SSRI antidepressants increase the chance of birth defects.
SSRI Depression Treatment
SSRIs are the primary way MDD is treated even among pregnant women. Despite evidence suggesting that SSRIs are not entirely safe during pregnancy, an estimated 13 percent of pregnant women receive SSRI prescriptions during all or part of their pregnancies. It is widely considered that improving a pregnant woman’s mood and relieving symptoms of depression will lead to better pregnancy outcomes. However, evidence shows these medications may lead to serious birth defects in developing fetuses. SSRIs such as Paxil, Zoloft, Prozac and Celexa increase the risks that a baby will be born with a serious birth defect. Some research suggests that fetal exposure to maternal SSRI therapy disturbs the physiological and cognitive domains during fetal developments.
On the other hand, MDD left untreated can lead to a wealth of problems for children when they reach childhood. For example, studies suggest that maternal stress or depression disrupts fetal neurobehavioral development and affects cognitive, emotional and behavioral outcomes throughout childhood. Children exposed to stress induced by depressed mother are at risk of developmental delays, impaired language development and low IQ scores. Further, untreated maternal depression can lead to children who suffer from depression and anxiety disorders.
Studies suggest that beyond childhood, neonatal SSRI exposure suppresses adult serotonergic signaling and elicits depression and anxiety-like behaviors in adulthood.
What is the Link Between Paxil and Birth Defects?
A 2015 British Medical Journal study found that Paxil and other paroxetine drugs increase the risk for certain heart defects in infants whose mothers took the drug during the first three months of pregnancy. The study confirmed increased risks for five previously reported birth defects associated with paroxetine, including heart defects, anencephaly and abdominal wall defects. Because of these findings, doctors should avoid prescribing Paxil to pregnant women. Women who took Paxil during pregnancy may give birth to children who suffer from:
- Cleft lip / cleft palate
- Brain and skull deformities
- Delayed physical or mental development
- Spina bifida
In addition, women who took Paxil during pregnancy may learn that their unborn children are suffering from potentially life-threatening conditions like:
- Septal heart defects
- Hypoplastic heart syndrome
- Persistent pulmonary hypertension (PPHN)
Further, the drug increases the chance of miscarriage or giving birth prematurely. The types of birth injuries associated with Paxil use can lead to lifelong medical treatment. If your child was born with birth defects as a result of Paxil use, contact The Carlson Law Firm. We have a qualified Paxil birth defects lawyer who can help you with your Paxil lawsuit against GlaxoSmithKline.
Persistent Pulmonary Hypertension of the Newborn
A second- and third-trimester risk associated with Paxil includes increased risks for persistent pulmonary hypertension of the newborn (PPHN). In 2011, the U.S. Food and Drug Administration updated the public on the use of SSRIs among pregnant women. It issued this safety announcement because of consistent findings that SSRIs increased the potential risk of PPHN, a rare heart and lung condition. The warning advised health care professionals not to alter current clinical practices to treat depression during pregnancy. However, it advised reporting any adverse events in SSRIs to the agency’s MedWatch Program.
PPHN occurs when a newborn is unable to adapt to breathing outside the womb. Babies with this condition require intensive care support including a mechanical ventilator to increase their oxygen level. In severe cases, PPHN leads to multiple organ damage; including brain damage and death.
PPHN is an extremely serious birth defect that can lead to lifelong medical bills. Your family does not have to pay these bills alone. Contact The Carlson Law Firm to speak with a qualified Paxil birth defects lawyer. We can help you take the first step to filing a Paxil lawsuit against GSK.
How Does Paxil Affect Fetal Development?
Studies suggest that the impact of SSRIs on fetal development may be through direct or indirect pathways that affect placental, maternal, or both, physiology. These effects can ultimately result in downstream effects on the fetus. The varying ways that a drug can reach a developing fetus means that the drug can affect development outcomes in different ways, depending on the stage of pregnancy.
Direct pathways suggest that SSRIs cross the placenta and enter the fetal circulation. This suggests that SSRIs directly target the developing fetus’ serotonergic system. In essence, this means that upon taking an SSRI medication, the drug goes directly to the fetus without first affecting the mother or the placenta.
Indirect pathways mean that the drug affects the mother or the placenta before being passed on to the fetus.
If you or a loved one took Paxil at any point during your pregnancy and had a child with birth defects, contact The Carlson Law Firm. You may be able to seek damages from GlaxoSmithKline with a Paxil lawsuit. We have Paxil birth defects lawyer who can help you navigate your claim against GSK.
What does the FDA say about Paxil?
While GlaxoSmithKline (GSK) has not been forced to recall Paxil, the Food and Drug Administration (FDA) has issued strong warnings about the drug and even required that GSK change the risk grade from C to D for pregnant women specifically. The lower the grade the less safe a drug is.
Paxil was introduced in 1992. Upon its introduction, it was classified as a drug with no known link or risk to increase birth defects. However, that classification was inaccurate. In December 2005, the FDA issues its fire warning about early results in a study that suggested Paxil may be dangerous for pregnant women to use during the first trimester or pregnancy.
Contact the Carlson Law Firm to speak with a Paxil birth defects lawyer about your Paxil lawsuit. Our firm is available 24 hours a day and seven days a week. We can help you navigate the complex American legal system to get the compensation you deserve.
Other Paxil Lawsuits
In addition to heightened risks of birth defects, the first wave of lawsuits GSK concerned Paxil withdrawal syndrome. The first wave of Paxil-related lawsuits were based on allegations that the drug was non-habit forming. However, the company allegedly knew about severe withdrawal symptoms as early as 1993. Withdrawal symptoms include:
- Flu-like symptoms
Increased Suicidal Ideation and Violent Behaviors
It is now clear that SSRIs like Paxil, Prozac and Zoloft cause a condition that leads to severe inner dysphorias such as restlessness, depression and anxiety, irritability, aggression or suicide attempts. This restlessness is a condition called akathisia and is linked to an increase in suicidal thoughts.
As a result, the FDA required GSK to add a black box warning for Paxil. Specifically, the drug is linked to an increased risk of suicide for children and users between the ages of 18-24. The FDA issues a black box warning when the agency has reason to believe that a certain prescription or non-prescription drug is life-threatening. There is no stronger FDA warning than a black box warning. The next step would be for the FDA to force GSK to recall the drug completely. The black box warning for Paxil was issued in 2004 because officials from the FDA, after various studies and analysis, determined that Paxil increases the risk of suicide and suicidal thoughts in children and young adults.
Despite the warning’s association with youths, the first suicide Paxil lawsuit to go to trial involved an adult U.S. patient. A Wyoming federal court jury awarded an $8 million verdict in favor of the family of a man who killed his wife, daughter and granddaughter before taking his own life. The man used Paxil for just two days before the murder-suicide. This case was followed by a significant amount of trials, with GSK opting to settle most cases.
Zoloft is a medication that belongs to the drug class SSRI. Developed and manufactured by Pfizer in 1990, Zoloft was released in the U.S. nine years after its release in the UK. By 2005, Zoloft was one of the most popularly prescribed antidepressants on the U.S. market with almost 30 million prescriptions written. Grossing $2.6 billion, it was also the sixth most prescribed brand-name prescription medication in 2005. Since its launch, Zoloft has brought in over $30 billion in revenue.
Used during pregnancy can cause birth defects. In July 2006, the FDA released two alerts related to Zoloft. The first alert was about the use of antidepressant medicines causing birth defects. The second alert was about the life-threatening condition known as serotonin syndrome which can occur when Zoloft and medicines used to treat migraine headaches (called 5-hydroxltryptamine receptor agonists) are taken together.
Which Birth Defects are linked to Zoloft?
After many patients’ babies were born with birth defects, a number of lawsuits were filed against Pfizer. These lawsuits have claimed that Pfizer did not offer adequate warnings about the risks associated with Zoloft. Birth defects that have been caused by Zoloft include holes in the heart, cleft palate, club feet, spina bifida, skull defects, Down’s syndrome, undescended testes in males, blindness, hernia, malformations and persistent pulmonary hypertension of a newborn. Other birth defects have included:
- Lung defects
- Respiratory problems
- Developmental delays
- Birth with organs protruding from the abdomen
- Brain and spinal cord defects
- Withdrawal syndrome
- Premature birth
Parents of children who have suffered from these injuries experience intense heartache and mental anguish. As a result, many are filing lawsuits for medical damages, lost wages and pain and suffering. In many cases, juries may award punitive damages as well. Contact a qualified SSRI or Zoloft Birth defects lawyer from The Carlson Law Firm.
The Carlson Law Firm Can Make A Difference in Your Paxil Lawsuit
Most personal injury law firms consist of individual lawyers. They may get help from other such as field experts or investigators, but it is very rare that you’ll find a personal injury law firm with in-house resources. The Carlson Law Firm maintains a team of professionals that includes more than 40 experienced lawyers, qualified and compassionate legal staff, and full-time registered nurses and investigators. Our team will investigate and prove that your child’s birth defect injuries were the result of GSK’s negligence in protecting pregnant women from its harmful drug. Moreover, we have a Paxil birth defects lawyer ready to take your call.
Thousands of people have already filed lawsuits against GSK, the makers of Paxil, for serious side effects such as birth defects, suicide, seizures and more. If you or someone you love currently takes Paxil or used to take Paxil and suffered from one or more of the serious birth defects mentioned above, then you may be entitled to financial compensation. Discuss your Paxil lawsuit with a Paxil birth defects lawyer at The Carlson Law Firm to learn more about your rights.
Contact The Carlson Law Firm to Schedule a free Paxil Lawsuit consultation
with a Qualified Paxil Birth Defects Lawyer.