Paxil (paroxetine) is a popular type of antidepressant which belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). It is used to treat mental disorders such as major depression, obsessive-compulsive disorder (OCD), anxiety and panic disorders, and post-traumatic stress disorder (PTSD). It is also used for other conditions such as bipolar disorder, premenstrual dysphoric disorder (PMDD), Diabetic neuropathy, and headaches.
The FDA has issued a number of warnings and required updates or changes to safety information in prescribing information for Paxil. GlaxoSmithKline has also faced a number of lawsuits filed by people or loved ones of those who have been injured by Paxil.
Paxil Side Effects
Paxil may cause common side effects such as nausea, insomnia, anxiety, drowsiness, headache, weakness, dry mouth, weight gain or loss, constipation and sexual dysfunction.
It may also cause more severe side effects or complications which may be serious or life threatening including:
- Suicide Risk – In 2004, the FDA found that there was an increased risk of suicide in children and adolescents taking Paxil. The risk may be worsened in patients who have bipolar disorder or a history of suicidal behavior and when medication is first started or undergoes dosage changes
- Birth Defects – increased risk of birth defects may include miscarriage, premature birth, heart defects, persistent pulmonary hypertension of the neonatal (PPHN), and physical abnormalities such as brain, skeletal or abdominal malformations like anencephaly, craniosynostosis or omphalocele, autism and delayed development.
- Serotonin Syndrome – caused by an excess of serotonin in certain areas of the brain which may be fatal or have symptoms such as changes in mental function, blood pressure, heart rate, muscle symptoms, fever or severe nausea, vomiting and diarrhea
- Withdrawal or Discontinuation Syndrome – patients who take SSRIs for a long period of time may become physically dependent. If Paxil is suddenly discontinued, serotonin withdrawal symptoms can occur including dizziness, nausea or diarrhea, headache, chills, electric or other odd sensations. Some withdrawal symptoms may last for a long time.
Severe side effects should be reported to a medical professional and may require emergency treatment.
Paxil is the brand name for the generic medication paroxetine. It is approved to treat a number of mental disorders such as major depression, obsessive-compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety, and posttraumatic stress syndrome. It has only been approved for use in adult patients.
It is also used as off-label treatment for bipolar disorder, premenstrual dysphoric disorder (PMDD) – Physical and psychological symptoms that start before the onset of a woman’s menstrual cycle), Diabetic neuropathy (tingling in the hands and feet), and headaches. Off-label use is allowed by a physician, but the manufacturer is not allowed to promote or advertise off-label uses.
The SSRIs work by affecting the serotonin receptors in the mood centers of the brain. Serotonin is a neurotransmitter (a chemical messenger) in the brain that helps maintain mood states. Specifically, the SSRIs block the reuptake of serotonin that has been released so that it can send more “feel good” messages to the rest of the cells in the mood centers.
Paxil was approved and marketed in 1992 by the British pharmaceuticals company SmithKline Beecham, which has now become GlaxoSmithKline, a huge multi-national conglomerate in the pharmaceutical industry. 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.
In its near-30 year history, Paxil has been the subject of multiple FDA warnings and lawsuits and 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.
Paxil Side Effects
Paxil, like other SSRI antidepressants has a number of side effects related to serotonin activity in the brain. Most Paxil side effects are mild-to-moderate and will go away with time, but others may be serious or life-threatening.
Common Paxil side effects may include:
- Dry Mouth
- Sexual dysfunction in both males and females
Some side effects of Paxil are more severe and may be serious or life-threatening.
Severe Paxil side effects may include:
- Balance or coordination disorders
- Racing heart or abnormal heart beats
- Allergic reaction
Paxil Birth Defects
Paxil may cause complications for women who are pregnant and their fetus 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.
When Paxil is taken by pregnant women it may cause:
- Premature Birth
- Hypoplastic Left/Right Heart Syndrome (HLHS, HRHS)
- Other septal heart defects
- Persistent Pulmonary Hypertension in Newborn (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
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 paroxetine because of an increased risk of birth defects and miscarriage or premature birth.
Paxil Suicide Risk
In 2004, the FDA required the addition of a black box warning for its 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 health care 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 the medication for depression should be closely monitored for signs of suicidal type behavior and other changes.
GlaxoSmithKline has faced thousands of lawsuits for injuries caused by Paxil including birth defects, suicides, drug withdrawal and other complications and many of these cases have been settled. People or loved ones of those who were injured by Paxil should seek legal advices.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.