Paxil Birth Defects Blog

As early as 2005, the US Food and Drug Administration (FDA) warned both health care professionals and patients about Paxil (paroxetine), an antidepressant drug which belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs).Paxil has been approved by the FDA to treat depression, anxiety disorders, post-traumatic stress disorders (PTSD), obsessive-compulsive disorder (OCD) and premenstrual dysphoric disorder (PMDD). Recently, Paxil is also used by women who suffered depression caused by migraine headaches.

The FDA said that Paxil increases the risks of birth defects when women take it during the first three months of pregnancy. Following a drastic increase in reported incidence of serious birth defects in children with Paxil, the FDA gathered data and conducted in depth studies to better understand birth defects observed from Paxil intake.In one of the studies conducted, it was found out that the risk of heart defects in babies whose mother has taken Paxil during the first three months of pregnancy is relatively higher by one percent compared to babies whose mothers have taken other antidepressants during the same period of gestation.

Although the drug has been approved by the FDA to treat depression and other psychiatric disorders, the FDA suggested that health care professionals should not prescribe Paxil to pregnant women in their first trimester of pregnancy or are preparing for pregnancy. The FDA also suggested that health care professionals should consider discontinuing the use of Paxil on pregnant women and prescribe other alternative antidepressants if necessary. Health care professionals were further advised to discuss the potential risk of Paxil birth defects with their patients.

The FDA addressed the pregnant patients not to use Paxil due to the increase of incidence associating birth defects in babies exposed to it. The FDA noted an increase in the risk of birth defects specifically heart defects in babies whose mother took Paxil on the first three months of pregnancy. The FDA urged women who are pregnant and taking Paxil not to stop but to consult their doctors right away. The agency emphasized that women who are pregnant or planning to be one should not start nor stop using Paxil without talking to their doctors.

The manufacturer of this drug, GlaxoSmithKline was also asked by the FDA to update the labeling of the product and change the pregnancy precaution category from C to D. Category D connotes a stronger warning that studies has been conducted on pregnant women and it was found out that the drug places the fetus on a higher risk. The FDA noted the significant increase on reported Paxil birth defects in babies who have been exposed to Paxil during pregnancy. The agency further stressed that Paxil is not advisable to be administered to pregnant women.

References:

• drugs.com/paxil.html
• fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108527.htm
• pdrhealth.com/drugs/paxil
• ncbi.nlm.nih.gov/pubmedhealth/PMH0001037/

 How big is your heart?

The human heart has the same size as the human fist. The size proportion of these two body parts starts from infancy and far into adulthood. The heart is an essential organ of the body that one must take care of. Exercise, proper diet and weight, and a healthy lifestyle allow the heart to function well. However, a heart abnormality could occur at birth otherwise known as a congenital heart defect.

What is a Congenital Heart Defect?

A congenital heart defect is a structural problem in the heart that is inborn. It can disrupt the normal flow of blood through the heart. They are also known as cyanotic heart disease or congenital cardiovascular malformations.

Common Congenital Heart Defects

Heart defects are among the most common type of birth defects. 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.

Simple congenital heart diseases include Atrial Septal Defect (ASD), Patent Ductus Arteriosus and narrowed valves. On the other hand, the most common complex heart defect is tetralogy of Fallot. 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

Environment and genes are contributory factors to developing a heart defect. However, the actual cause could not determined in most instances. Alcohol consumption, nicotine and cocaine dependence during pregnancy could result to heart abnormalities. Other predisposing factors include 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.

Caution is advised when taking drug medication during pregnancy. 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 risks of pre-natal medication as presented in the Paxil birth defect issue are not worth taking by pregnant women.

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

In July 2011, Cable News Network (CNN) featured a research by Lisa Croen, director of autism research, at Kaiser Permanente Northern California. She discovered that babies who were exposed to antidepressants during the first trimester of their mothers' pregnancy were almost four times as prone to autism spectrum disorder (ASD) than those babies who were not. Her summary of findings: taking antidepressants during pregnancy may cause child autism.

Antidepressant drugs, such as Paxil, bring severe side effects to women who were prescribed with this drug during the first three months of pregnancy, as was reported by the US Food and Drug Administration (FDA). Newborns may suffer from congenital birth defects and withdrawal symptoms that could last for months and even years. The baby’s heart malformations usually happen when the mother took Paxil during the first trimester of pregnancy, during which the baby’s heart was still developing 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. Other defects are limb abnormalities and craniosynostosis, which refers to the deformation of the skull. It was also known that newborns may also have low blood sugar and experience difficulty in breathing, vomiting, seizures, tremor and irritability.

The FDA released a public health advisory that said:

“FDA is advising health care professionals to discuss the potential risk of birth defects with patients who are taking Paxil and who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals avoid prescribing Paxil in women who are in the first three months of pregnancy or who are planning pregnancy, unless other treatment options are not appropriate.”

GSK was required by the FDA to change the pregnancy category of Paxil from C to D because of the earlier stated Paxil birth defects. The meaning of the D category is that studies conducted in pregnant women had presented proof that the drug puts the fetus at stake. Medical professionals said that it important to properly verify the type and timing of the medications prescribed for pregnant women as well as those who are planning to get pregnant soon. Hence, to avoid any untoward incidents, consumers particularly women should always consult a doctor first before taking any medication.

Paxil Side Effects

Careless use of Paxil can lead to serious side effects, medical industry journals warned, as the women who took the drug while pregnant are more likely to suffer from several complications, aside from illness in their children.

GlaxoSmithKline (GSK) is the manufacturing company of the antidepressant Paxil, generic brand name for paroxetine pydrochloride. Media reports have it that when Paxil was out on the market, it quickly became one of the largest-selling, globally available antidepressant drugs . Recently, Newsweek published a research from The Journal of the American Medical Association, which claimed that Paxil is a little more beneficial than placebos, but it has numerous side effects.

A major serious Paxil side effect was determined in cases in which numerous pregnant women were prescribed with the drug during the first three months of pregnancy; their babies suffered from birth defects and their mothers went through withdrawal symptoms that lasted for days, weeks and even years after delivery.

Pregnant women and also those who are planning to get pregnant were advised by the American College of Obstetricians and Gynecologists to avoid taking Paxil. A 2010 research of the Swedish Medical Birth Register (MBR) backed up this recommendation with the results of their study. There is a wide range of birth defects associated with Paxil and the studies have linked the drug to cardiovascular defects like ventricular septal defects and atrial septal defects. These usually happen when the mother took Paxil during the first trimester of pregnancy, during which the baby’s heart was still developing in the womb. Another serious Paxil side effect is pulmonary hypertension of the newborn (PPHN), which is a subtle form of high blood pressure in the lungs of the baby. PPHN can be extremely severe and may lead to death in some cases. Other alleged Paxil-associated defects include limb abnormalities and craniosynostosis, in which the skull is deformed. These birth defects can be very critical. While some after-effects can mend on their own, others cannot and can even lead to further operations and complications. It was also known that newborns may also have low blood sugar and experience difficulty in breathing, vomiting, seizures, tremor and irritability.

The US Food and Drug Administration (FDA) released a Public Health Advisory that said:

“FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.”

GSK was required by the FDA to change the pregnancy category of Paxil from C to D because of the earlier stated Paxil birth defects. The meaning of the D category is that studies conducted in pregnant women had presented proof that the drug puts the fetus at stake. Medical professionals said that it important to properly verify the type and timing of the medications prescribed for pregnant women as well as those who are planning to get pregnant soon. Hence, to avoid any untoward incidents, women should always consult a doctor first.

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/

The Persistent Pulmonary Hypertension (PPHN) is a specific type of lung and breathing problem found in newborns and generally diagnosed within 12 hours of birth. Medical studies have recently associated PPHN as one of the serious side effects of antidepressant drugs which belong to the Selective Serotonin Reuptake Inhibitor (SSRI), one of which is Paxil. A clubbed foot is among the potential birth defects that Paxil causes aside from PPHN.

Women who took SSRIs during their third trimester were six times more likely to deliver babies born with PPHN than those who didn't take SSRIs during their third trimester, according to a New England Journal of Medicine study. Known to cause a variety of problems in patients, SSRI drugs have received an FDA “Black Box Warning” on the label for a risk of suicidal behavior for patients under 24 years old. The birth defects are the most recent side-effects that have been identified affecting children whose mothers took the drug during pregnancy.

As it only affects approximately just one in 700 births, PPHN may not be a common birth defect but still it could cause serious short and long term problems. In the womb, a developing baby’s oxygen needs are provided from the placenta through the umbilical cord. Bypassing the lungs, the pulmonary artery instead sends blood right back to the heart through a fetal blood vessel called the ductus arteriosis. After birth, when the baby takes her first breaths, the ductus arteriosis normally permanently closes and the pulmonary artery begins pumping blood through her lungs and throughout the rest of the circulatory system.

In a baby with PPHN, the baby’s circulatory system does not “switch over.” The ductus arteriosis remains open and the lungs continue to be bypassed, resulting in oxygen deficient blood being circulated throughout the body. Despite being able to breath, the baby is deprived of oxygen because her lungs are “out of the loop”, which can severely damage the lungs and other organs. The exact cause of PPHN is unknown in many cases but when a baby’s mother has taken an SSRI drug during pregnancy, particularly later in pregnancy, this is almost certainly the cause.

Previously, Paxil lawsuits have been filed because of the drug’s potential to cause suicidal thoughts among 24 years old and below. This time, lawsuits are expected to be filed by mothers whose children were born with birth defects after they had taken Paxil without knowing of its harmful side effects on their babies.

Anencephaly, a neural tube defect found at birth is characterized by the absence of the skull and some parts of the brain. There are certain risk factors considered on why some babies develop this defect including the use of the antidepressant Paxil. When a woman has depression even during pregnancy, medications are still prescribed to manage the condition. However, this might also mean that she might risk her pregnancy and her baby might develop complications such as birth defects. With this, she should watch out for side effects or talk to her physician about this. If a woman just found out that she’s expecting a child, she should however, not stop taking the medication immediately as abrupt discontinuation of Paxil can cause withdrawal syndrome.

Paxil and Pregnancy

Paxil is an antidepressant under the SSRI drug class which has a generic name of Paroxetine. The U.S. Food and Drug Association has released a strong warning regarding its use to pregnant women as birth defects have been associated when this drug is taken during pregnancy. This medication was also reclassified from Pregnancy Category C to Category D. Drugs in Category D have shown significant risks to the fetus in controlled studies of pregnant women but the benefits of the therapy may outweigh the risks, so it would be up to your doctor to weigh down the pros and cons of the drug therapy. One of the mentioned birth defects was the neural tube defect anencephaly.

Some Facts on Anencephaly

Anencephaly is one of the most common neural birth defects which occur in 1 of every 10,000 births. This takes place when the upper part of the baby’s neural tube fails to develop. Upon observation, a child with anencephaly has no skull and some parts of the brain are missing. The condition may also be accompanied by facial deformities and heart defects. There is no current treatment for anencephaly but you can talk to your physician for supportive measures and palliative care. This is a very serious condition and prognosis is usually not good as death results a few days after birth. The cause of this condition is actually unknown but it has been said that low folate intake as well as medications can be considered as causes. This medical condition is allegedly a Paxil birth defect that is why the FDA and GlaxoSmithKline, Paxil’s maker, released warnings on the use of the drug in pregnant women.

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

When the FDA asked GSK to reclassify Paxil it was in pregnancy category class C. Officially the FDA defines a drug that is pregnancy category class C 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."

Since the FDA request Paxil is currently pregnancy category class D.

A new question arises with the class reclassification of Paxil which is if it will affect how the drug is prescribed to pregnant women. Now that Paxil is 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. Some of the potential risks of taking Paxil during the final three months of pregnancy may include: general irritability due to withdrawal from the medication, seizures or persistent pulmonary hypertension (PPHN), a serious and life-threatening lung condition. One 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. The FDA requested 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 would like to start taking Paxil for your signs and symptoms of depression, it is best if you consult with your doctor first.

All children follow the developmental milestone of maturity where they pass through predictable stages of growth and development. The child needs to achieve a milestone for the time period and failure to do so would result to a delay in development. The mother’s health during pregnancy, environment and genes may have caused the said delay. Drug intake during pregnancy also plays a big part in the development of the child, Paxil and developmental delay.

Development is evaluated through five different areas, namely: gross motor movements, fine motor movements, speech and language, cognitive or intellectual and social and emotional aspect. The five areas may be affected by the delay or in other cases, just a single aspect. But these areas should develop together for they are interconnected. A delay in one aspect would also mean a delay in other aspects. Awareness of the delay often happens when the parents observe that the child is not achieving some milestones like children their age.

Developmental delay is diagnosed only when the nature and reason of delay is confirmed. Some delays are transient and children may progress on at a normal rate. These delays can be managed through constant exposure to helpful opportunities and support from the family. Persistence of delay may be caused by problems with seeing, hearing, moving and communicating. Further evaluation and management is required to address this kind of delay.

Children with developmental delay have the same needs as the other children. They may not learn new skills at the same pace with other children, but they learn it in the same way. With this, they need extra help in one or more areas of their development. They need to be more exposed to opportunities and instances where they can learn. Regular exposure is the main solution to manage the delays. Support, patience and comfort of the family are vital for a child with delays in development.

Delay in development is first observed at home by the parents and can be confirmed by the doctor. The child will be given a series of tests first before developmental delay is diagnosed. It is recommended that parents adhere to a regular check-up with their doctor for conditions like this to be detected early. For additional information on developmental delay and other birth defects, it is recommended that you talk to a health care provider.