On September 27, 2005, the Food and Drug Administration (FDA) and GlaxoSmithKline notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil to describe the results of a study of major congenital malformations, which are physical body or organ malformations existing at birth.
The study suggested women taking Paxil are at an increased risk of their children being born with major birth defects as compared to other antidepressants. GlaxoSmithKline’s study of more than 3,500 pregnant women revealed that those who took Paxil were twice as likely to bear children with major birth defects vs. other antidepressant drugs. The most common defects were cardiovascular and occurred about 50 percent more than in the general population.
In December 2005, the FDA advised healthcare professionals of early study results, which suggested that Paxil increases the risk for birth defects—particularly heart defects—when women take it during the first three months of pregnancy.
Paxil is a drug approved by the FDA to treat depression, generalized anxiety disorder (GAD), social anxiety disorder, panic disorder, obsessive compulsive disorder (OCD), and post-traumatic stress disorder (PTSD). Paxil is a selective serotonin reuptake inhibitor (SSRI) drug, which has been linked to a higher risk of suicide rates in adults taking the drug. On September 14, 2004, the FDA voted 15-8 to recommend SSRI drug manufacturers add a black box warning label stating that these drugs can be linked to suicidal thoughts and behavior in children and adolescents. The black box warning is the most strongly worded and serious label available. All magazine and television ads are required to include the warning.
Additionally, in February 2005, Spanish researchers reported that babies born to women who were taking SSRIs may experience neonatal withdrawal syndrome within the first few days of birth, and this association was highest in mothers who were taking Paxil.
The FDA issued the following statement: "Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine [Paxil] therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients."
The results of a study that looked at the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN) were recently published in a medical journal.
Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die.
The study results showed that babies born to mothers 20 weeks or later in their pregnancies who took selective serotonin reuptake inhibitors (SSRIs) had a higher chance (6 times as likely) to have persistent pulmonary hypertension (PPHN), than babies born to mothers who did not take antidepressants during pregnancy.
Birth defects are the result of abnormalities in the structure, function, or the chemical balances of a baby when they are born. These abnormalities often result in the physical and/or mental disability of the child and can result in death.
About 150,000 babies are born each year with birth defects. Many of these defects are thought to be the result of environmental factors such as drug or alcohol abuse, infections, or exposure to certain medications.
Paxil is an SSRI, which stands for "selective serotonin reuptake inhibitor." SSRIs are the newest and most popular form of antidepressant drugs on the market. SSRIs have largely replaced the antidepressants of old (tricyclics and monoamine oxidase inhibitors), which interfered with neurotransmitters and receptor sites all over the brain and resulted in many undesirable side effects.
SSRIs, as their name implies, focus specifically on serotonin. The brain will release serotonin and then reabsorb it (known as reuptake) so it can be used at a later time. Physiological depression occurs when the brain doesn’t have enough serotonin to maintain a stable mood; interfering with the reuptake of this chemical back into the brain (which is the design and function of SSRIs) allows for more messages to be sent throughout the brain and results in a steadier, happier mood.
The FDA recommends, "Healthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients."
Consult with your physician if you have questions concerning this medication. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician. Paxil® is a registered trademark of GlaxoSmithKline and is used here only to identify the product in question. This law firm is not associated with, sponsored by, or affiliated with the Food and Drug Administration, HealthDay, WebMD, GlaxoSmithKline, Forbes, or the March of Dimes. Do not stop taking any prescription medications without first consulting a doctor.
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