Paxil
Paxil Side Effects & Birth Defects
Recent studies have raised concerns that Paxil may cause cardiac (heart), pulmonary (lung) and other birth defects in infants whose mothers took Paxil during pregnancy. Information developed in recent studies reviewed by the FDA showed that women who took Paxil during pregnancy were one and a half to two times as likely to have a baby with a heart defect compared with women who took other antidepressants or women who were not taking this type of medication at all. If you or a loved one took Paxil during pregnancy and your baby was born with a heart defect, you should contact us immediately, we may be able to help you obtain compensation for your child's injuries.
Side Effects Associated with Paxil include, but are not limited to the following:
• Heart Birth Defects (Atrial or Ventricular Septal Defects, Murmurs, etc)
• Lung Birth Defects (Persistent Pulmonary Hypertension)
• Craniosynostosis (resulting in an abnormally shaped head)
• Abdominal Birth Defects (Omphalocele)
• Cranial Birth Defects (Craniosynostosis)
What is Paxil?
Paxil (paroxetine hydrochloride) is an antidepressant medication that is part of a family of drugs called selective serotonin re-uptake inhibitors (SSRIs). Paxil is sold as Seroxat outside of the United States and as Paxil (paroxetine HCl) in the United States.
Paxil is currently approved by the Food and Drug Administration (FDA) for the treatment of major depressive disorder, generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder, obsessive-compulsive disorder (OCD) and posttraumatic stress disorder (PTSD) in adults.
Paxil is used to treat:
• Depression
• Panic disorder
• Social anxiety disorder (SAD)
• Obsessive-compulsive disorder (OCD)
• Posttraumatic stress disorder (PTSD)
• Generalized anxiety disorder (GAD)
• Premenstrual dysphoric disorder (PMDD)
Who Should Not Take Paxil?
Never take Paxil if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking Paxil close in time to an MAOI can result in serious, sometimes fatal reactions including:
• High body temperature
• Coma
• Seizures (convulsions)
MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.
Never take paroxetine if you are taking Mellaril (thioridazine), used to treat schizophrenia, because it can result in serious heart beat problems.
What Are The Risks?
• Suicidal thoughts or actions: See FDA Alert.
• Stopping Paxil: Do not stop taking Paxil suddenly because you could get side effects. Your healthcare professional will slowly decrease your dose.
• Bleeding problems: Paxil may cause bleeding problems, especially if taken with aspirin, NSAIDs (nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen), or other drugs that affect bleeding.
• Mania: You may become hyperactive, excitable or elated.
• Seizures: You may experience a seizure (convulsion) even if you are not taking paroxetine close in time with a MAOI.
• Pregnancy: Tell your healthcare professional if you are or may be pregnant (see FDA Alert [12/2005] above). In addition to the issues discussed in the alert, babies delivered to mothers taking paroxetine late in pregnancy have developed problems, such as difficulty breathing and feeding.
• Sexual problems: You may have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire).
• Other side effects include weakness, dry mouth, constipation, yawning, infection, diarrhea, sweating, dizziness, tremor, nervousness, nausea, difficulty sleeping, decreased appetite, and sleepiness.
• Tell your healthcare professional about all your medical conditions, especially if you have liver or kidney disease, or glaucoma. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby.
Are There Any Interactions With Drugs or Foods?
• Paxil may interact with medicines other than the ones already mentioned in this information sheet. These interactions can cause serious side effects. Tell your healthcare professional about all medicines, vitamins, and herbal supplements you take.
• If you plan to drink alcohol, talk to your healthcare professional.
Paxil Related Birth Defects & Side Effects
Birth Defects
Heart Birth Defects
The FDA issued a Public Health Advisory for Paxil on December 8, 2005 based on U.S. and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy may be associated with an increased risk of heart birth defects. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations.
Lung Birth Defects
Persistent pulmonary hypertension (PPHN) is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care.
On July 19, 2006 the FDA issued another Public Health Advisory for Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine, Symbyax (olanzapine and fluoxetine) and Zoloft (sertraline) based on a study that suggests there may be additional risks of SSRI medications during pregnancy. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.
Abdominal Birth Defects
GSK - GlaxoSmithKline, maker of Paxil, sent a letter to doctors and healthcare professionals in September, 2005 advising them of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI-antidepressant were more likely than those who were not exposed to have an infant with omphalocele (an abnormality in newborns in which the infant's intestine or other abdominal organs protrude from the navel. The strongest effect was reported to be with Paxil (paroxetine) which accounted for 36% of all SSRI exposures.
Cranial Birth Defects
GSK - GlaxoSmithKline included in the September, 2005 "Dear Doctor" letter that the authors of the above study also found an association of exposure to any SSRI-antidepressant and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull.)
Other Side Effects
It has been found that Paxil® and other drugs in the same class-selective serotonin re-uptake inhibitor (SSRI) can cause a condition called akathisia (severe inner restlessness) that in turn is associated with suicidal tendencies.
According to FDA data, at least 110 American kids have killed themselves while taking antidepressants during the past decade. Paxil and its risk of suicide has been making headlines as mounting pressure from critics and Congress has been put on the FDA to publicly disclose reports associating antidepressant medications to increased risk of suicide among children. The FDA withheld an internal finding showing Paxil and suicide occurs twice as often as kids on sugar pills, as well as other antidepressant medications, at the start of 2004.
In June 2004, New York Attorney General Eliot Spitzer filed a lawsuit accusing GlaxoSmithKline (GSK) of burying several studies that indicated Paxil was ineffective in the treatment of children and adolescents and may increase suicidal thoughts. The lawsuit, filed in New York State Supreme Court, also accuses Glaxo officials of misrepresenting data on the prescribing of Paxil to children.
In response to the lawsuit, Glaxo published the results of nine pediatric clinical trials showing Paxil is mostly ineffective in treating children and may actually increase the risk of suicidal tendencies.