What Is Paxil?
Paxil is the name brand for the generic medication paroxetine and is a popular type of SSRI antidepressant. It is approved for the treatment of mental disorders such as major depression, obsessive-compulsive disorder (OCD), anxiety and panic disorders, and post-traumatic stress disorder (PTSD). It is also used to treat other conditions such as bipolar disorder, premenstrual dysphoric disorder (PMDD), diabetic neuropathy, and headaches.
SSRI antidepressants, like Paxil, work by increasing the activity of a chemical messenger in the mood centers of the brain. This chemical messenger is the neurotransmitter, serotonin, which acts to regulate sleep and mood and may help provide the satiety or “satisfaction” sensation. Paxil increases the level of serotonin in the brain.
Paxil is the brand name for paroxetine and was originally manufactured by SmithKline Beecham. SmithKline Beecham became GlaxoSmithKline, a huge multi-national conglomerate in the pharmaceutical industry. GlaxoSmithKline has become GSK. Paxil hit the market in 1992. During its peak year of 2007, more than 18 million prescriptions were written for Paxil and it had become the fifth most popular drug in the US.
The FDA has issued several warnings and required updates or changes to safety information in prescribing information for Paxil. GlaxoSmithKline has faced many lawsuits filed by people or loved ones of those injured by Paxil.
Is Paxil FDA-Approved?
Over the years, the U.S. Food and Drug Administration (FDA) has approved Paxil to treat several conditions. Though it has been used to treat other mental health conditions, Paxil has not been approved for those uses. Paxil is not approved for use in children. Some pediatricians may prescribe Paxil to children if the benefits offset the dangers of taking the medication.
In its 30-year history, Paxil has been the subject of multiple FDA warnings and lawsuits. The manufacturer has settled several claims regarding accusations of packaging and mislabeling errors, sham litigation to block generic manufacturing of the medication, withholding safety information, and the unlawful promotion of Paxil use in children.
What Is Paxil Prescribed To Treat?
Paxil is prescribed by doctors to treat conditions it is approved to treat as well as conditions for which it is not approved.
Paxil is approved to treat the following conditions:
- Obsessive-compulsive disorder
- Social anxiety disorder
- Panic disorders
- Posttraumatic stress disorder
- Generalized anxiety disorder
- Premenstrual dysmorphic disorder
What Is Depression?
Major depressive disorder (MDD) is commonly referred to as depression. Depression is a disorder that affects a person’s mood, causing a constant feeling of sadness coupled with a loss of interest.
Symptoms of depression include:
- Loss of interest in normal activities
- Feelings of guilt or worthlessness
- Excessive crying
- Lack of energy
- Loss of concentration
- Changes in appetite
- Changes in sleep patterns
- Suicidal thoughts and tendencies
What Is Obsessive-Compulsive Disorder?
Obsessive-compulsive disorder (OCD) causes people to have persistent, unwanted obsessions that cause them to feel compelled to do something repeatedly. These obsessions may present in the form of thoughts, ideas, or sensations. These repeated actions can be a variety of behaviors, such as handwashing, and may considerably affect a person’s day-to-day life.
What Is Social Anxiety Disorder?
Social anxiety disorder is also referred to as social phobia and is characterized by intense anxiety, self-consciousness, and embarrassment due to the fear of being negatively judged by others. Those intense feelings lead to the avoidance of situations and may affect a person’s daily life in school, work, or in relationships.
Panic disorders are one variety of anxiety disorders. People with panic disorder experience unanticipated and recurrent episodes of heightened fear that are coupled with physical symptoms such as chest pain, shortness of breath, dizziness, heart palpitations, or abdominal discomfort or distress. Episodes caused by panic disorder are not induced by an obvious stressor.
What Is Posttraumatic Stress Disorder?
Posttraumatic stress disorder (PTSD) refers to a psychiatric disorder that can occur in a person who was exposed to a traumatic event. Exposure can be by having experienced the event, by having witnessed the traumatic event, or by having secondhand experience such as learning about a loved one’s violent death or hearing details of someone else’s trauma. Examples of traumatic events include war, combat, natural disaster, major accident, terrorist attack, or rape. Threats of serious injury, death, or sexual assault are also considered to be traumatic events.
What Is Anxiety?
Anxiety is a natural response to stress. It may cause feelings of nervousness or anxiousness. Anxiety can be helpful in some situations, and it may alert to danger or help a person pay attention. Anxiety in general differs from anxiety disorders, which are characterized by excessive worry, fear, or anxiety which are not proportionate to the situation and affect a person’s ability to function normally.
Generalized anxiety disorder (GAD) is not just anxiety. It involves continuous, extreme worry that is tough to control, interferes with daily life, and lasts for at least six months. Symptoms of generalized anxiety disorder include:
- Constant worry or anxiety
- Inability to make decisions
- Difficulty concentrating
- Difficulty sleeping
Premenstrual dysmorphic disorder (PMDD) is an extreme form of premenstrual syndrome (PMS). PMDD may be caused by an abnormal reaction to hormonal changes that occur during every menstrual cycle. This abnormal reaction can cause serotonin deficiency in some people. PMDD is characterized by symptoms that occur before menstruation and end a few days after the start of a person’s period. These symptoms are so severe that they interfere with daily life tasks.
Is Paxil Prescribed To Treat Other Conditions?
Paxil is sometimes prescribed “off-label” to treat conditions other than those for which it is approved. When a medication is prescribed off-label, that means that it does not have FDA approval to treat that condition. Federal law allows for medications to be prescribed for non-approved conditions, but pharmaceutical companies are prohibited from marketing medications to treat those non-approved conditions.
These off-label uses may be provided for both children and adults Conditions for which Paxil has been prescribed off-label include:
- Obsessive-compulsive disorder in children
- Social anxiety disorder in children
- Bipolar disorder
- Diabetic neuropathy
- Separation anxiety
- Postpartum depression
- Premature ejaculation
Before prescribing Paxil for any of these off-label uses, doctors should justify their reasoning and discuss it with their patients.
Paxil, like most medications, causes side effects in some patients. Most of these side effects are mild and will go away on their own with time. However, some patients may experience severe side effects and should seek medical attention right away. These severe side effects are dangerous and may become life-threatening in some cases.
Mild side effects caused by Paxil include:
- Dry Mouth
- Sexual dysfunction in both males and females
Paxil can cause severe side effects. These side effects should be reported to a healthcare professional immediately.
Severe side effects caused by Paxil may include:
- Balance or coordination disorders
- Racing heart or abnormal heartbeats
- Allergic reaction
Paxil may cause side effects that are significant and may be life-threatening. These side effects have been the basis of lawsuits filed against the manufacturer. These are:
- Birth defects
- Increased risk of suicide
- Serotonin syndrome
- Withdrawal or discontinuation syndrome
Is Paxil Safe To Take When Pregnant?
Taking Paxil may cause complications for pregnant women and their fetuses and may result in birth defects. In 2005, the FDA issued a warning regarding Paxil use in pregnancy and upgraded the medication’s classification to Pregnancy Category D, indicating that human research shows that the drug poses a risk to a developing fetus.
Medical groups such as the American College of Obstetrics and Gynecology (ACOG) recommend that women who are or intend to become pregnant should not use Paxil (paroxetine) because of an increased risk of birth defects and miscarriage or premature birth.
Paxil may cause “non-teratogenic effects” in newborns. These effects are not birth defects, but they may include complications that require lengthened hospital stays, respiratory support, and the use of a feeding tube after delivery.
Serious effects in newborns noted with Effexor may include:
- Respiratory distress
- Temperature instability
- Difficulty feeding
- Constant crying
Pregnant or nursing mothers face serious risks. Taking Paxil while pregnant carries the potential risk of birth defects and may be linked to serious complications in some pregnancies.
- Premature Birth
- Hypoplastic Left/Right Heart Syndrome (HLHS, HRHS)
- Other septal heart defects
- Persistent Pulmonary Hypertension in Newborns (PPHN)
- Cranial defects
- Spina Bifida
- Cleft Palate or Cleft Lip
- Club Feet or other malformation of limbs
- Delayed development
- Autism spectrum disorder
- Pulmonary stenosis and atresia
Paxil is associated with considerable neonatal mortality and morbidity.
Is It Safe To Take Paxil While Breastfeeding?
Paxil is excreted in breast milk, so nursing mothers who are taking Paxil should exercise caution.
In 2004, the FDA required the addition of a black box warning for Paxil’s increased risk of suicide. A black-box warning is a notification that is placed at the top of all prescribing information so that it will be the first thing seen by a physician or healthcare provider. The black-box notification is the most serious warning that any medication can get.
The black-box warning on Paxil and other SSRI antidepressants identifies an increased risk of suicidal thinking and behavior in children, adolescents, and young adults following short-term use for a major depressive disorder. The warning also advises that patients who take medication for depression should be closely monitored for signs of suicidal type behavior and other changes.
Paxil use may cause “serotonin syndrome” which occurs when too much serotonin builds up in the brain. It is more likely if it is taken with other medications that also affect serotonin including treatments for migraine, cough suppressants, and certain herbal remedies.
Serotonin syndrome may include symptoms such as:
- Unusually high fever
- Increased heart rate and changes in rhythm
- Loss of balance or coordination
- Confusion and hallucinations
In some cases, serotonin syndrome may be life-threatening. All medications should be discussed with a physician to avoid drug interactions.
Patients who take SSRIs for a long time may become physically dependent. If Paxil is suddenly discontinued, serotonin withdrawal symptoms can occur. These symptoms may include dizziness, nausea, diarrhea, headache, chills, electric, or other odd sensations. Some withdrawal symptoms may last for a long time. It is important to discuss quitting any medication with a doctor.
Paxil’s manufacturer, GSK, has faced several lawsuits regarding Paxil and claims associated with the medication. Most of these lawsuits have involved birth defects, deaths, or other injuries. Paxil has been the subject of more than 40 warnings from drug regulatory agencies in seven countries. In 2011, the US Food and Drug Administration (FDA) warned health professionals about the increased risk of persistent pulmonary hypertension (PPHN) in newborn babies whose mothers had taken Paxil. This came after warnings about the risk of other types of birth defects in babies born to mothers using Paxil.
Warnings for Paxil were also issued in Australia about an increase in death rates among female Paxil users and a public health warning was issued in the U.S. about Paxil’s risk for inducing serotonin syndrome. This condition can cause hallucinations and hypertensive crisis, and in some cases, be fatal.
There are two main types of lawsuits that have been filed regarding potential claims patients and their loved ones may have against the manufacturer of Paxil.
These two lawsuit types are:
- Product liability
- Wrongful death
Both lawsuit types can result in monetary awards to the Plaintiff. They also help to raise awareness about dangerous products.
A medication manufacturer is charged with ensuring its medications are not unreasonably dangerous to patients and are safe for patients to take. Plaintiffs who have filed Paxil lawsuits allege that the manufacturer did not provide adequate warnings about the possible severe risks of taking Paxil. The plaintiffs argue that the injuries they or their loved ones sustained would not have resulted had they been properly warned about the risks associated with taking Paxil.
A wrongful death lawsuit can be brought by certain immediate family members of a deceased person against the individual or company that caused the loved one’s death. Those family members or close loved ones who may sue vary depending on state laws. Wrongful death lawsuits have been brought against the manufacturer of Paxil in situations where a baby died because of a birth defect linked to Paxil and in situations where it is alleged that Paxil led to suicide.
Paxil’s maker, GlaxoSmithKline (GSK), has paid billions in settlements and compensation for injuries, birth defects, and wrongful death caused by the medication. GSK has been named in antitrust claims and was ordered to pay a fine of $3 billion in fees to settle U.S. Department of Justice charges and lawsuits with other governmental agencies. Those claims alleged that Paxil had been illegally promoted as safe for treating depression in children, despite not having received the go-ahead from the FDA for use by people younger than 18.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.