Archive for 2011

Congenital Heart Defects

Posted on Thursday, December 22, 2011 by Paxil Birth Defects

How big is your heart?
The size of your heart is about the same size as your fist.  The size proportion of these two body parts starts from infancy and far into adulthood.  The heart is the body engine that keeps one going.  Exercise, a clean lifestyle, a healthy diet and weight will go a long way in keeping your heart fit.  However, there are cases when the heart is defective at birth, a condition known as a congenital heart defect.

What is a Congenital Heart Defect?
 A congenital heart defect is structural flaw in the heart that is present at birth.   It may cause the blood flow to slow down, go in the wrong direction, go to the wrong place, or it may block the flow completely.  Sometimes, they are referred to as cyanotic heart disease or congenital cardiovascular malformations.

Common Congenital Heart Defects
 Heart defects are the most common of abnormalities at birth.  About 35,000 infants are born with it each year in the United States.  The defect ranges from mild, requiring little or no treatment, to severe which could potentially put an infant’s life at risk.   They account for majority of birth defect-related fatalities.

Examples of  non-severe congenital heart diseases are Atrial Septal Defect (ASD), Patent Ductus Arteriosus and narrowed valves.  Tetralogy of Fallot is the most common of complex heart defects.  It is a condition wherein not enough blood is able to reach the lungs to get oxygen, and oxygen-poor blood flows to the body.

Causes
Heart defects can be caused by prenatal environmental as well as genetic factors.   However, the actual cause could not determined in most instances.   Alcohol consumption, nicotine and cocaine dependence during pregnancy could result to heart abnormalities.  Other possible causes are medication, viral infections and chronic illnesses such as diabetes, phenylketonuria (PKU) and deficiency in the B vitamin folic acid.   Heredity and genes likewise contributes to the development of heart defects.  

Prevention
The first trimester of a mother’s pregnancy is critical.   The heart, like some other body organs, starts to develop shortly after conception.   Complications and abnormalities resulting to abnormalities in the heart are likely to occur.




During pregnancy, drug medication should not be taken without the doctor’s clearance. Many drugs contain chemicals or substances that could potentially harm the fetus. As an example, the U.S. Food and Drug Administration (FDA) had issued several health advisories on the potential benefits and risks of antidepressants during pregnancy.  Based on FDA advisory, pregnant women who took Paxil were 1.5 to two times at risk of having babies with a congenital heart defect compared to those who took other antidepressants.  The issue of pre-natal drug medication, like the Paxil birth defect, is one that should not to be cast aside by any pregnant woman.

URL References:

  • nhlbi.nih.gov/health/health-topics/topics/chd/types.html
  • americanpregnancy.org/birthdefects/congenitalheart.html
  • fi.edu/learn/heart/development/development.html
  • fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm124348.htm
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Birth Defects Due To Paxil

Posted on Tuesday, November 8, 2011 by Paxil Birth Defects


Paxil is a popular drug taken as tablet or oral suspension for depression, OCD, anxiety and panic disorder for adults.    Paxil is manufactured by GlaxoSmithKline and has been available in the market since 1992.  It helps prevent re-absorption of a neurotransmitter in the brain called Serotonin thus it is under the Selective Serotonin Reuptake Inhibitor drug class.   Preventing the re-absorption of Serotonin can increase the general well being of the patient. Most pregnant women undergo fluctuation of emotions that at times needs to be medicated because it is not already manageable.   For those patients that have been harmed by taking the drug made by GlaxoSmithKline, the company has agreed to settle it with the amount of $3 Billion.

When studies have found out that taking Paxil in the 1st trimester of pregnancy will result to birth defects for the fetus, the FDA has changed its pregnancy category from C to D.   Atrial and ventricular septal defects were the common heart defects seen in fetuses.   Not only can it cause heart defects but it can also cause lung defects for the fetus. Thoughtful consideration of the benefits and disadvantages in taking the drugs before it would be taken because of the potential harm it could cause in the fetus.   Options can be given by your doctor if you want to get pregnant but still taking Paxil.  Likewise if you are already pregnant and is still taking Paxil, it should be consulted with your doctor.

A study for the safe usage of Paxil was done in 2010 even if it was launched way back 1992. It was then that it was upgraded to a higher pregnancy risk category.  Breastfeeding should also be consulted with the doctor. Consult your doctor if you are breastfeeding your infant.  There were some cases that have surfaced stating that they were pregnant when they had the prescription of Paxil and that their children were born with heart defects. Many cases are now being made public about women who were pregnant when they took Paxil and as a result have babies that have a heart defect. 

GlaxoSmithKline is now facing cases from women who have babies with birth defect due to Paxil. Cases about Paxil birth defects are now increasing.


References:
  •          medicinenet.com/paroxetine/article.htm
  •         health.ezinemark.com/reports-show-paxil-birth-defects-more-likely-during-first-trimester-7d300a23f680.html
  •          uniteforlife.wordpress.com/category/paxil-birth-defects/
  •          drugs.com/paxil.html

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Victims of Antidepressants Try to Raise Awareness on Antidepressant Harms

Posted on Thursday, October 20, 2011 by Paxil Birth Defects

In dealing with depression, medical professionals frequently prescribe oral medications like antidepressants and also psychotherapy. However, reports from patients, results of various medical studies, and Food and Drug Administration (FDA) warnings suggest that antidepressants like Paxil, Zoloft and Effexor may not be the safest way to cure depression and anxiety disorders because of their tendency to cause harmful effects. These include increased suicide risk, sexual dysfunction, hallucinations, abnormal personality changes, atypical mood shifts, eating disorders, and sleeping problems. Birth defects to newborns had been also reported, especially if the mother took the drug during the first trimester of pregnancy. The website BCLocalNews.com published an article on October 17, 2010 about a British Columbian couple trying tointensify awareness about infant exposure to antidepressants. This couple believes that their son died apparently from the wife’s exposure to antidepressants while pregnant.

On February 21, 2009, the mother—Christiane Schultz—was prescribed Effexor while she was pregnant and gave birth to her son, Matthew. Sadly, he died immediately two hours after he was born. She and her husband Amery supposed that her Effexor use contributed to Matthew's death. From then on, they have been trying to raise awareness on the hazards of antidepressant drugs to pregnant women and their children.

According to the studies, there is a wide range of birth defects linked to Paxil such as cardiovascular malformations in the form of atrial septal defects and ventricular septal defects. These typically occur when the mother has taken Paxil within the first trimester of pregnancy, during which the baby's heart is still forming in the womb. Moreover, pulmonary hypertension of the newborn (PPHN) is another Paxil side effect. It is some kind of high blood pressure in babies’ lungs. PPHN can be tremendously serious and it may lead to death in extreme cases. Limb abnormalities and craniosynostosis (skull deformation) are also other birth defects that are allegedly blamed on Paxil. These defects can be very serious. Certain defects can correct themselves while others cannot and may even lead to complications and surgeries. It was also known that newborns may also have low blood sugar and experience difficulty in breathing, vomiting, seizures, tremor and irritability.

The consumers should also be aware that various PaxilLawsuit is presently being filed by victims against the manufacturer of the drug, GlaxoSmithKline.


References:


  • adrugrecall.com/paxil/birth-defect.html
  • medicinenet.com/script/main/art.asp?articlekey=57323
  • webmd.com/news/20051208/paxil-stronger-birth-defects-warning
  • paxil.lawsuitinformation.org/


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Common Paxil Heart Birth Defects

Posted on Friday, September 30, 2011 by Paxil Birth Defects


A black box warning about pregnancy has been given to Paxil since 2005, this warning states that pregnant women have to consult with their doctor before starting Paxil as it can lead to serious Birth Defects. There are also several studies that have shown that Paxil can potentially cause miscarriages.

However, Paxil has also been known to cause birth defects, the more common of which deal with the heart of the newborn. A study conducted in 2006 and published in the New England Journal of Medicine found that PPHN was six times as likely to occur in infants born to mothers who used Paxil or another SSRI medication during the final twenty weeks of pregnancy.  The main reason for this is that the high blood pressure and poor oxygen flow through the infant’s body is the result of incomplete development of the respiratory system, caused by a malfunction in one of the blood vessels that functions during fetal growth.

 Below is a list of the most common heart birth defects that can potentially be caused by Paxil:

•   Persistent pulmonary hypertension, or PPHN, is a lung condition that occurs in newborns and has been linked to maternal use of the antidepressant Paxil.  Newborns that are diagnosed with PPHN are usually unable to breathe properly because of constricted blood vessels in the lungs and consequently cannot get enough oxygen to vital organs such as the brain and kidneys.  PPHN often requires intensive medical treatment and sometimes surgery.

•    Atrial Septal Defect (AVD) and Ventrical Septal Defect (VSD) can be described as , a hole between the two upper chambers of the heart (atrial) or the two lower chambers of the heart (ventrical).Often AVD or VSD will heal themselves; in more severe instances the infant will undergo surgery. 

•    Hypoplastic Left Heart Syndrome this is when a newborn is born with an underdevelopment of one of the components of the left side of the heart: the left ventricle, aortic valve, or the left side of the mitral valve. 

 Studies have shown that Paxil has the ability to have a serious side effect on women who are taking the drug for their signs and symptoms of depression while pregnant; these women should be wary of potential Paxil Birth Defects to their babies.

Reference:
http://www.adrugrecall.com/paxil/birth-defect.html

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Paxil Birth Defects May Include PPHN

Posted on Friday, September 2, 2011 by Paxil Birth Defects

Persistent pulmonary hypertension of the newborn (PPHN) can be defined as the failure of the normal circulatory transition that occurs after birth. The main characteristics of PPHN is hypoxemia and right-to-left extrapulmonary shunting of blood. This plus the increased cravings for alcohol are some of the possible side effects of Paxil.

Now what does this all mean? PPHN occurs when a newborn's circulation system does not adapt to breathing outside the womb. While a fetus is in the womb, it gets its oxygen from its mother's placenta through the umbilical cords, so the lungs need little blood supply. There is high blood pressure in the lungs, so blood in the pulmonary artery is sent away from the lungs to the other organs through a fetal blood vessel, called the ductus arteriosus.

After a child is born and takes its first breaths, the blood pressure in their lungs falls and there is an increased blood flow to the lungs, where oxygen and carbon dioxide are exchanged. Soon after the blood is then returned to the heart and pumped back out to the body. The ductus arteriosus constricts and permanently closes in the first day of life.However, in babies with PPHN, the pressure in the lungs remains high and the ductus arterious remains open, allowing blood to be directed away from the lungs.

The first step in PPHN treatment is to maximize the amount of oxygen delivered to the baby's lungs (and, in turn, to the blood), so 100% oxygen will be given through a tube inserted directly into the baby's trachea (windpipe). The oxygen is administered by a mechanical ventilator, which does the work of breathing for the baby. The PPHN treatment would be given in conjunction with other treatments for the illnesses that may have contributed to the initial development of PPHN (such as low blood sugar, pneumonia, or other infections).

PPHN is a life-threatening heart condition for newborns. Studies have shown that PPHN is also a possible Paxil birth defect. If you would like to start using Paxil for your signs and symptoms of depression, consult with your doctor first.

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Paxil Birth Defects Cause FDA to Request Change in Paxil Pregnancy Class Category

Posted on Wednesday, August 17, 2011 by Paxil Birth Defects

In 1979 the United States Food and Drug Administration (FDA) introduced drug classification categories of fetal risks due to pharmaceuticals. The manufacturer of Paxil, GlaxoSmithKline, was asked by the FDA in 2005 to reclassify Paxil from Pregnancy Class C to Pregnancy Class D. With the reclassification many women are beginning to think if taking Paxil during pregnancy is really worth it.

Before the FDA asked GSK to reclassify Paxil it was in pregnancy category class C.  According to the FDA a pregnancy category class C drug is defined as: “Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."

After the FDA request Paxil is now pregnancy category class D. The FDA officially defines a pregnancy category class D drug as: “There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”

A new question arises with the class reclassification of Paxil which is if it will affect how the drug is prescribed to pregnant women. Taking into consideration that Paxil is now classified as a potential risk to a developing fetus many women may stray from taking the drug as the potential risks may outweigh any positive effects the drug may have. The Potential risks of taking Paxil during the last trimester of pregnancy have been known to include: general irritability due to withdrawal from the medication, seizures or persistent pulmonary hypertension (PPHN), a serious and life-threatening lung condition. However, an instance in where Paxil may be prescribed to a pregnant woman is if the patient has already taken other antidepressants with no positive response.

The FDA’s request to GSK to reclassify Paxil from pregnancy category class C to pregnancy category D may have caused many current users of Paxil to rethink using the drug.  This reclassification may also change how the drug is prescribed to women who are pregnant or are looking to become pregnant because of possible Paxil birth defects. If you are looking to take Paxil for your signs and symptoms of depression, consult with your doctor first.

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Associated With Using SSRI Antidepressants

Posted on Wednesday, August 10, 2011 by Paxil Birth Defects

Around one in every 1,000 babies born in the United States have clubfoot.  A comparatively common birth defect, one or both feet can be affected and ranges from mild to severe.   Medical experts call this “Congenital Talipes Equinovarus” and is often seen by the foot turning inward and downward at birth. People believe its cause is unknown but there are studies that say taking antidepressants during pregnancy could lead to birth defects.  Some studies even point a link between Paxil and macrocephaly.

Clubfoot does not cause any discomfort or pain and a baby with this malformation would continue developing normally until he or she starts to stand and walk.  When the deformity is not treated, he or she could walk on the sides of his or her feet.  This could be further complicated by infection on the part used for walking and over time, it could lead to arthritis.

This malformation could be treated through non-surgical means. Usually, it involves manipulation, casting, splinting, and taping.  Its major goal is to make the foot appear normal and restore its function.  An orthopedic specialist is usually the person to address this.  It is ideal that clubfoot be treated as soon as it is detected after birth since this is when the newborn's bones is easiest to reshape.

Nowadays, many experts believe that genetic and environmental factors contribute to clubfoot.  Environmental factors include smoking, infection and drug use.  Paxil is an antidepressant classified under Selective Serotonin Reuptake Inhibitor (SSRI) that doctors prescribe even to pregnant women to treat mood disorders and depression. Classified by the FDA as a drug that could cause potential harm to the developing fetus, Paxil is one of the drugs being looked at closely because it allegedly causes an array of birth defects among newborns.

To mothers of children who have clubfoot as a result of taking Paxil, there is a legal option that you can take.  Its manufacturer has an obligation to answer the apparent flaws in its product.

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FDA Study Causes GSK to Change Warning Labels on Both Product and Website

Posted on Wednesday, July 27, 2011 by Paxil Birth Defects

On September 27, 2005 the United States Food and Drug Administration (FDA) released the results of a study which showed that Paxil has the potential to cause major birth defects in newborns whose mothers took Paxil during the first trimester of pregnancy.  The FDA made a public statement with regards to the study which stated: "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."

In response to the FDA study the manufacturer of Paxil, GlaxoSmithKline (GSK), has updated warning labels on their product.GSK also placed a warning about Paxil on their website after the study’s publication, this warning states: "Tell your doctor if you are pregnant or plan to become pregnant as there is a potential risk to the fetus with [Paxil]. Some studies of [Paxil] in pregnant women have suggested a possible increased risk of malformations, while others have not shown such a risk."

Concerning the possible birth defects that Paxil can cause GSK has placed a statement on its website as well this statement says: "Babies born to mothers who have taken antidepressants, including SSRIs such as Paxil, in the third trimester of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil.”

A study concerning Paxil and the major birth defects in newborns it can possible cause especially in mothers have taken the drug during pregnancy, has been released by the FDA. The FDA study has also caused the manufacturer of Paxil, GlaxoSmithKline, to change warnings on both its website and product. If your child has been born with a major birth defect and you believe that your consumption of Paxil during pregnancy is the cause, then taking legal action could be your next logical step.For more information on any potential legal action you may take, visit with a Paxil  lawyer as soon as possible, most lawyers will give you a free consultation and many will not charge you unless your case receives compensation by the courts.


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