Paxil, the brand name for the generic medication paroxetine, is an SSRI primarily used to treat depression. SSRIs, or Selective Serotonin Reuptake Inhibitors, increase levels of the neurotransmitter serotonin by blocking its reabsorption in the brain. Through inhibiting the reabsorption of this neurotransmitter, Paxil has been shown to boost mood in individuals suffering from depression.
In May of 1996, Paxil was first approved by the FDA for use in treating panic disorder. Up until that point, there was only one drug available for treating panic disorder and it was habit forming. Because of this, Paxil was marketed positively as being a non-habit forming option for treating panic disorder.
According to the FDA-Approved Medication Guide, Paxil is indicated for use in treating the following conditions:
- Major Depressive Disorder
- Panic Disorder
- Obsessive Compulsive Disorder
- Social Anxiety Disorder
- Generalized Anxiety Disorder
- Posttraumatic Stress Disorder
Side Effects of Paxil
Detailed information about the potential side effects of Paxil is also provided in the FDA-Approved Medication Guide. The guide instructs Paxil users to have a conversation with their doctor before discontinuing use of Paxil, as they could experience dangerous withdrawal symptoms. The potential side of effects of Paxil include:
When first starting the medication or increasing the dose, Paxil users may experience suicidal ideation. If you are experiencing an extreme change in mood, or having thoughts of harming yourself, please contact your health care provider immediately.
Serotonin Syndrome or Neuroleptic Malignant Syndrome. If Paxil users experience symptoms such as a change in mental status (confusion, hallucinations, coma), fever, muscle rigidity or nausea they should contact their healthcare provided as soon as possible.
- Vision changes, pain or swelling in the eyes.
- Rash, swelling, difficulty breathing, or other symptoms of an allergic reaction.
- When combined with anti-inflammatories or blood thinners, Paxil may cause abnormal bleeding.
- Grandiose ideas, rapid speech, extreme restless, extreme increase in energy, impulsivity or other symptoms of mania.
- Weight or appetite changes.
- Older adults may experience low sodium levels in the blood.
Paxil Birth Defects
Paxil, like other SSRIs may increase the risk of birth defects in mothers who have been prescribed the medication during pregnancy. Because more women are prescribed antidepressants than men, it is important the women of childbearing age understand that taking Paxil during pregnancy may put their child at risk for serious birth defects.
In a press release published in 2005, the FDA announced that they had requested the the manufacturers of Paxil change the pregnancy class of Paxil from a C to D. Class C Pregnancy drugs include medications which have been studied in animal research shown some harm to the fetus, but there is inadequate research to declare it unsafe for use during human pregnancies. A class D pregnancy drug, however, is a medication which has been proven dangerous for use during human pregnancies. The FDA advises against taking Paxil while pregnant.
The potential birth defects when Paxil is taken during pregnancy include:
- PPHN or Persistent Pulmonary Hypertension (relating to a newborn): This condition causes low oxygen levels and makes it difficult for the newborn to breath when not in the womb.
- Heart Defects: When Paxil is taken during pregnancy, there are increased risks of the baby developing Hypoplastic Left Heart Syndrome or septal heart defects. Hypoplastic Left Heart Syndrome occurs when the newborn’s heart is underdeveloped. A septal heart defect is characterized by a hole in the wall of the newborn’s heart, which may cause damage to the lungs over time due to increased blood flow.
- Omphalocele: a defect of the wall of the abdomen which causes the newborn to be born with their intestines outside of their body.
- Cleft lip or cleft palate: During the first trimester, the lip and the palate are formed. Research has found an increased risk of abnormalities of the lip or palate when SSRIs such as Paxil are taken during pregnancy.
- Brain or Skull Defects: When taken during pregnancy, Paxil can increase the risk of Anencephaly, or missing portions of the brain or skull.
- Spina Bifida: Damage of the nerves or spinal cord caused by a neural tube defect that prevents the backbone, which protects the spine, from forming completely.
Over 5,000 individuals have filed a lawsuit against GSK concerning side effects of Paxil, according to DrugWatch.com. These lawsuits were filed based on the belief that GSK failed to inform doctors and consumers of the risks associated with taking Paxil. Many of these lawsuits have been filed by women who were not adequately warned of the dangers of taking Paxil while pregnant. The company had paid an estimated 1.14 billion in birth defect lawsuits by the year 2010.
The first case concerning birth defects was filed against GSK in 2009. The mother who filed the lawsuit was prescribed Paxil during her pregnancy, and was not warned of the risks associated with the medication. Her child developed a fatal heart defect, and Paxil was found to be the cause of this defect. The lawsuit ended in the mother’s favor, and she awarded 2.5 million dollars as compensation for medical costs as well as pain and suffering.
In addition to birth defect lawsuits, GSK has been sued for failing to disclose risk of suicidal attempts and dangerous withdrawals when taking Paxil.
Pharmaceutical companies should be held responsible for warning users of their medications with the associated risks. The lawsuits filed by Paxil users insist that GlaxoSmithKline failed to market their product honestly when they did not warn users of the increased risk of birth defect associated with taking Paxil. The belief is that birth defects occurred as a resultant of negligent marketing.
Know Your Legal Rights
The FDA requires pharmaceutical companies to inform consumers of the risk factors associated with the medications they produce and distribute. You have legal rights if your child was born with defects, or developed a fatal birth defect, after Paxil was taken during the pregnancy. Do you know if you have reason to file a lawsuit against GlaxoSmithKline?
If you took Paxil while pregnant, and your baby was born with birth defects, a lawyer may be able to help you receive personal injury damages.