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Paxil® Linked to Birth Defects
On September 27, 2005, the Food and Drug Administration (FDA) and GlaxoSmithKline notified health care 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 (1). 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 (2). The most common defects were cardiovascular and occurred about 50% 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 drug injury and birth defects—particularly heart defects—when women take it during the first three months of pregnancy (3).
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) (4). 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 (5). 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 of a potential drug injury.
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 (6).
The FDA issued the following statement: "Health care 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 (1)."
Persistent Pulmonary Hypertension (7/2006) FDA Update:
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 (six times as likely) to have persistent pulmonary hypertension (PPHN), than babies born to mothers who did not take antidepressants during pregnancy.
Source: Healthcare Professional Sheet with FDA Alert, from the Food and Drug Administration
If you or someone you care about has suffered the anguish of a child born with birth defects after taking prescription drugs, you may need a drug injury lawyer. Your initial consultation is free and we will handle your inquiry with the utmost level of care and professionalism.
What Are Birth Defects?
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 (7).
Three major types of birth defects:
- Structural Abnormalities. When part of the baby's body is either missing or deformed (can be internal or external). Common examples of structural abnormalities are heart defects, which affect around one out of 125 babies born and are the leading cause of abnormality-related infant deaths.
- Metabolic Abnormalities. Metabolic abnormalities are birth defects from genetic factors, which result in the child being able to produce enzymes necessary to sustain a normal, healthy life and occur with far less frequency (about one in 3,500 infants are affected) than structural abnormalities.
- Congenital Infections. Infections in the mother that cause birth defects in children. Sexually transmitted diseases are an example of congenital infections which may cause defects in babies if the mother contracts one of the diseases early on in pregnancy or prior to conception.
What Are SSRIs?
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.
What Should I Do if I Took Paxil?
Do not stop taking any prescription medications without first consulting a doctor. If you or someone you love has taken Paxil and has had a child with birth defects, contact our drug injury law firm immediately for a free and confidential case evaluation today. We also have birth injury lawyers and defective product attorneys who can assist your case. We want to help.
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 speak with a doctor.
Sources:
- The Food and Drug Administration's 2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements from www.fda.gov. Accessed on 04/11/06.
- "Paxil's Birth Defects Warning Strengthened" from WebMD (www.webmd.com). Accessed on 04/11/06.
- "FDA Advising of Risk of Birth Defects with Paxil" from www.fda.gov. Accessed on 04/11/06.
- What Does Paxil Treat? from www.paxil.com. Accessed on 04/11/06.
- Consumer Affairs' "FDA Warns Paxil Users of Birth Defect Risks."
- "New Warning Issued on Paxil" by Amanda Gardner, HealthDay Reporter. Accessed on 04/11/06.
- Birth Defects from the March of Dimes Perinatal Data Center. Maternal, Infant, and Child Health in the United States, 2001. Accessed on 04/11/06.
Paxil® is a registered trademark of GlaxoSmithKline and is used here only to identify the product in question.
This drug injury 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.
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At Ferrer, Poirot & Wansbrough, we are dedicated to protecting victims' rights. We are an experienced personal injury law firm taking cases throughout the country. Our drug injury lawyers have successfully defended the rights of thousands of clients just like you. Complete a free online consultation form or dial (866) 589-0257 to get the help you need.
We handle several case types, including: auto accident, birth injury, defective medical device, defective product, drug injury, environmental injury, medical malpractice, motorcycle accident, nursing home abuse and truck accident. If you have been seriously hurt, call us now.
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