Pregnant woman and women who are trying to get pregnant are routinely prescribed prenatal vitamins containing at least 1,000 milligrams of folic acid as a way to improve the health of the unborn child. In the mid-1990s, the Food and Drug Administration (FDA) took the effort one step further, requiring that folic acid be added to breads, cereals, flours, corn meals, pastas, rice and other grain products. Researchers say that move likely contributed to the 26 percent drop in neural tube defects, according to the U.S. Centers for Disease Control and Prevention. Now they say folic acid also may be tied into the six percent drop in heart defects each year after folic acid was added to grain supplies, researchers say.

While congenital heart defects are rare, such news is encouraging. “If you can reduce such a significant abnormality by doing something as simple as a public health intervention by increasing folic acid in the grain supply and encouraging individuals to take folic acid supplementation, it’s a win-win situation,” said Dr. Diane M. Ashton, deputy medical director of the March of Dimes.

Besides consuming a folic acid supplement or consuming foods high in folic acid, another step a woman can take to improve her chances of having a healthy baby is to discuss with her doctors any medications she is taking. Some drugs, such as SSRI antidepressants like Paxil, have been linked to a an increased risk of overall birth defects, and specifically heart defects.

SOURCE: Paxil and Pregnancy › Folic acid may help reduce risk of heart defects in newborns

SSRIs (selective serotonin reuptake inhibitors) are antidepressants that affect serotonin levels in the brain. It’s not fully understood how they work but it is thought they provide higher levels of serotonin at the brain receptor site. SSRI discontinuation syndrome can occur during or following interruption or the lowering of dosage or the discontinuation of an SSRI or SNRI (serotonin-norepinephrine reuptake inhibitor) antidepressant.

Side effects can occur between 24 hours to one week after reduction or stoppage of dosage and they can be overwhelming. Side effects may include dizziness, electric shock-like sensations or “zaps,” sweating, nausea, insomnia, tremor, confusion, and vertigo.

If you are considering coming off your antidepressant, Summer Beretsky on PsychCentral.com offers some tips on how to make the process in a blog that details her challenges when she came off Paxil. Her weaning process was a months long ordeal that involved tapering down her dosage by splitting or shaving pills over the course of seven months. During that time of weaning off she says she suffered from side effects headaches, lethargy, depression, dizziness, the “zaps,” and nausea, to name a few. Read her personal story and tips on gradually weaning off SSRIs on the site’s blog.

SOURCE: Paxil and Pregnancy › Coming off antidepressants can take months of effort

Seeking help from a health care provider is vital not only to the mother, but to her unborn child. Depressed mothers-to-be may not have the energy to take care of themselves or seek optimal prenatal care. She may even rely on smoking cigarettes or drinking alcohol to cope, which can have detrimental effects on an unborn child. Health care providers can discuss healthier options, such as group or one-on-one therapy. In some cases, antidepressants may be recommended.

According to the Mayo Clinic, few medications have been proven safe beyond a doubt for use during pregnancy, which is why many doctors advise their patients who are pregnant or are considering pregnancy to wean off most drugs. However, some antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), should only be taken during pregnancy after a woman weighs the risks with her doctor because of the possibility of serious birth defects.

Common SSRIs that have previously been prescribed for depression during pregnancy include Celexa, Prozac, Zoloft and Paxil. However, with all those medications there is a possible risk of persistent pulmonary hypertension, or PPHN, in the newborn. The risk is so rare that Celexa, Prozac and Zoloft are still considered options for use during pregnancy.

However, in 2005, a scientific study indicated that women who took Paxil during the first three months of pregnancy had a greater risk of their unborn child developing birth defects – in particular heart defects – than any other antidepressant. As a result of that study, GlaxoSmithKline, makers of Paxil, updated the PRECAUTIONS section of its medication label discouraging use of Paxil during pregnancy.

The Mayo Clinic urges women to consult with their doctors and learn the risks and benefits of antidepressants during pregnancy before making a decision.

SOURCE: Paxil and Pregnancy › Mothers-to-be should weigh risks of antidepressants during pregnancy

According to Women’s Health, changing hormones throughout a woman’s life can trigger depression, including times such as puberty, during and after pregnancy, and during perimenopause. Some women also experience depressive symptoms right before their period. Women with a personal or family history of depression are more prone to suffer from postpartum depression.

It is identified by symptoms such as trouble sleeping, lack of interest, feelings of guilt, loss of energy, difficulty concentrating, changes in appetite, restlessness or slowed movement, and thoughts or ideas about suicide. It also can begin at any time within the first three months after delivery. And it can seriously threaten both the woman and her baby, which is why women who think they are experiencing postpartum depression, or individuals who are concerned about a loved one, should seek medical attention immediately.

Postpartum depression can be treated through support groups, counseling sessions with a mental health professionals and even antidepressants from a group of selective serotonin reuptake inhibitors (SSRIs). The most common ones are Zoloft, Paxil, Celexa and Prozac. A woman should discuss with her doctor if she plans to breastfeed while taking medication as many antidepressants can get into her breast milk and may cause problems for the baby.

She will want to discuss going off the medication before getting pregnant again, as some antidepressants, such as Paxil, have been linked to serious birth defects in babies whose mothers took the medication during pregnancy.

SOURCE: Paxil and Pregnancy › Postpartum depression puts mother, baby at risk

Numerous studies have not found an increased risk of major birth defects associated with the use of SSRIs during pregnancy. However, exposure to SSRIs late in pregnancy has been associated with short-term complications in newborns including jitteriness, mild respiratory distress, excessively rapid respiration, weak cry, poor muscle tone, and admission to the neonatal intensive care unit. Unpublished data regarding the use of Paxil® during the first trimester of pregnancy have raised concerns about an increased risk of congenital heart malformations. Thus, the US Food and Drug Administration issued a public health advisory regarding the use of Paxil® during pregnancy and the manufacturer changed its pregnancy category from C to D. A Category C classification is for drugs that have been shown to harm fetuses in animal studies but have not been adequately studied in humans. A Category D classification means a drug has been found to be harmful to human fetuses.

The potential risk of SSRIs during pregnancy must be weighed against the risk of depression relapse if the medication is discontinued. Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications. Fetal echocardiography should be considered for women who were exposed to Paxil® in early pregnancy.

ACOG’s Committee on Obstetric Practice emphasizes that decisions about depression treatment should involve the obstetrician and the mental health clinician, along with the patient, ideally prior to pregnancy. However, because approximately 50% of pregnancies are unplanned, preconception planning for women with depression will not always be feasible, and treatment decisions about SSRIs will undoubtedly occur during pregnancy.

Committee Opinion #354, “Treatment with Selective Serotonin Reuptake Inhibitors During Pregnancy,” is published in the December 2006 issue of Obstetrics & Gynecology.

Source: The American College of Obstetricians and Gynecologists

SOURCE: Paxil and Pregnancy › ACOG Issues Opinion on SSRI Antidepressant Use During Pregnancy

ACOG’s Committee on Obstetric Practice “recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible,” read the statement, which is in the December issue of Obstetrics & Gynecology.

The guidelines come a full year after the U.S. Food and Drug Administration(FDA) issued a warning about possible birth defects associated with Paxil when the drug is taken during the first trimester of pregnancy.

This warning was based on two studies. The first found about a 2 percent risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared with a 1 percent risk in the general population.

The second study found that the risk of heart defects was 1.5 percent in babies whose mothers took Paxil in the first three months of pregnancy, compared with 1 percent in babies whose mothers took other antidepressants in the first trimester. The most common defects were cardiovascular.

“Since the FDA warnings a year ago, most ob/gyns have been trying to avoid Paxil during pregnancy,” noted Dr. Jennifer Wu, an obstetrician/gynecologist at Lenox Hill Hospital in New York City. “This is just a formal statement by ACOG.”

The initial FDA warning came in September of 2005. In December of the same year, the FDA instructed Paxil’s maker, GlaxoSmithKline, to reclassify the drug from a Category C to D (a stronger warning) for pregnant women. Category D means studies in pregnant women have demonstrated a risk to the fetus.

Other reports had indicated that SSRIs, the category of antidepressants which includes Paxil as well as Celexa, Prozac and Zoloft, may cause newborns to have withdrawal symptoms.

ACOG acknowledged that these potential problems must be weighed against yet another study which found that pregnant women who discontinue their antidepressant medication are five times more likely to relapse into depression than women who continue with the medication.

“Untreated depression has its own risks, including low weight gain, alcohol and substance abuse, and sexually transmitted diseases, all of which have negative maternal and fetal health implications,” the statement said.

Women of reproductive age have the highest prevalence of major depressive disorders, with ACOG experts estimating that about 1 in 10 will experience a bout of major or minor depression sometime during pregnancy or the postpartum period.

Ideally, these issues should be considered before a woman becomes pregnant, the ACOG panel said. But, given that about half of all pregnancies are not planned, many decisions regarding treatment will inevitably happen after the woman has conceived. Fetal echocardiography, which looks for heart trouble, should be considered for women who were exposed to Paxil in early pregnancy, the statement recommended.

“Women who have certain health problem such as depression really should try to plan their pregnancies with their ob/gyn and psychiatrist,” Wu confirmed. “The major danger will be to women who have an unplanned pregnancy and don’t realize it until they’re two months along. There’s a lot of organ development during that time, and exposure to certain SSRIs may pose some dangers.”

SOURCE: Health Day News

SOURCE: Paxil and Pregnancy › Ob/Gyn Group Urges Pregnant Women to Shun Paxil

A second study suggests there may be additional, though rare, risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which 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. 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. The study was too small to compare the risk in one drug compared to another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.

The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns coming from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing. In addition, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiology study suggesting that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects (see FDA Public Health Advisory for Paxil dated December 8, 2005).

The uncommon potential risk to the newborn of PPHN has not been confirmed by additional studies. Uncertainty about these rare events and their potential impact on the newborn, along with the potential risk to the mother of recurring depression if she stops her antidepressant medicines during pregnancy, makes decisions about the treatment of depression in pregnant women especially challenging for health care professionals and patients.

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant without first consulting their physician. The decision to continue medication or not should be made only after there has been careful consideration of the potential benefits and risks of the medication for each individual pregnant patient. If the decision is made to stop treatment with SSRIs before or during pregnancy, this should be done with a healthcare professional, according to the prescribing information for the drug, and patients should be observed closely in case their depression comes back.

The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. In the meantime, the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. Prescribing information will be updated with information from additional studies when this information becomes available.

SSRIs and a Combination Drug Containing an SSRI

• Celexa (citalopram)
• Fluvoxamine
• Lexapro (escitalopram)
• Paxil (paroxetine)
• Prozac (fluoxetine)
• Symbyax (olanzapine/fluoxetine)
• Zoloft (sertraline)

Source: FDA Public Health Advisory

SOURCE: Paxil and Pregnancy › Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns

Results of two early studies reviewed by the FDA showed that women who took Paxil during the first three months of pregnancy were about 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 in the general population. Most of the heart defects reported in these studies were of the type known as atrial and ventricular septal defects (holes in the walls of the chambers of the heart). These types of heart defects can range in severity from relatively minor that resolve without treatment to those that cause serious symptoms and need to be repaired surgically. The risk for this type of heart defect is approximately one per cent of births in the general population. In one of the studies with Paxil, women taking the drug had an approximately two per cent risk of having a baby with heart defects, and in the second study, women taking Paxil in the first trimester had an approximate 1.5% risk of having a baby with heart defects.

According to the FDA announcement:

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.

The manufacturer of Paxil, Glaxo Smith Kline, has changed the product labeling from pregnancy class C to class D, meaning that that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy with Paxil may outweigh the potential risks to the fetus.

It’s important to note that these conclusions are preliminary and are based on early results of two studies. The FDA is collecting additional data and waiting for the final results of these and other studies in order to better characterize and understand the risk for birth defects associated with Paxil. If you’re currently taking Paxil, talk to your doctor if you are pregnant or planning to become pregnant. He or she can advise you on the best course of action for your situation and medical condition

Source: MedicineNet

SOURCE: Paxil and Pregnancy › Updated Product Labeling Warns of Birth Defect

The company cited newly analyzed data from a retrospective epidemiologic study of major congenital malformations in infants, saying that “preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants.”

Changes in the drug’s labeling are being made after consultation with the U.S. Food and Drug Administration (FDA).

Current FDA-approved labeling lists paroxetine as a pregnancy Category C drug. Category C is defined as drugs with “no adequate and well-controlled studies in humans to determine the effect on the fetus.” Current labeling reminds prescribers that paroxetine during pregnancy should be used only if the potential benefit justifies the potential risk.

Information will be added to the product label indicating that of 3,581 pregnant women exposed to paroxetine or other antidepressants during the first trimester, use of paroxetine, compared with other antidepressants, was associated with an “increased risk of overall major congenital malformations.”

Specifically, women who took paroxetine were 2.2 times more likely to give birth to an infant with a major congenital malformation and 2.08 times more likely to give birth to an infant with a cardiovascular malformation than women on other antidepressants. Of 14 infants with a major congenital malformation born to women taking paroxetine, 10 of those with cardiovascular malformations had ventricular septal defects.

The new labeling goes on to note that a separate study based on the Swedish Medical Birth Registry “evaluated 4,291 infants exposed to SSRIs in early pregnancy. This study reported no increased risk for overall major malformations in 708 infants born to women with paroxetine exposure early in pregnancy.”

In the company’s “Dear Healthcare Provider” letter regarding the new labeling, GSK said that “it is important to note that because the GSK study was designed to evaluate the relative risk of congenital malformations in infants born to women exposed to antidepressants, the study did not include a comparison to infants who were not exposed to any antidepressant. Therefore, these data should be viewed within the context of the overall prevalence of congenital malformations in the general population, which is estimated in the U.S. to be approximately 3 percent for any malformation, and approximately 1 percent for cardiovascular malformations alone.”

GSK reviewed other epidemiological studies of SSRI exposure during pregnancy in its “Dear Healthcare Provider” letter, as well as several case-control studies. In addition, it cited the National Birth Defects Prevention Study of infants delivered from 1997 through 2001.

In that study, women who took any SSRI were more likely than those who were not exposed to have an infant with omphalocele.

The strongest effect was reported in that study to be with paroxetine, which accounted for 36 percent of all exposures to an SSRI. Infants born to mothers taking paroxetine during the first trimester were found to be 6.3 times more likely to have an omphalocele compared with infants born to mothers who took no SSRIs. An association was also found between SSRI exposure and infants being born with craniosynostosis.

GSK concluded, “The differences in the results from the available studies and the diversity in type of abnormalities recently reported makes it difficult to definitively conclude a causal relationship for any particular congenital abnormality with paroxetine.”

The company, in cooperation with FDA requests, is conducting additional epidemiologic studies “to more fully understand these preliminary findings.”

SOURCE: Paxil and Pregnancy › New Paxil Labeling Warns Of Birth-Defect Risk

Paxil Linked to Twice as Many Birth Defects

GlaxoSmithKline recently conducted a study of major birth defects in infants born to women who took antidepressants (including Paxil) during the first trimester of pregnancy.

In a study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants, according to the FDA.

Birth defects are very rare in the U.S., and it’s not certain what role, if any, Paxil played in the birth defects seen in the study, notes GlaxoSmithKline.

Changes have been made to the labeling information on pregnancy precautions that accompanies Paxil, says the FDA.

GlaxoSmithKline is a WebMD sponsor.

Most of the birth defects seen in the study were heart related; the most common heart malformations were ventricular septal defects, which are holes between the heart’s two main pumping chambers. These are common birth defects overall as well.

The study was a retrospective epidemiological study. That means it looked at large groups of people in hindsight. There was no data on birth defects in babies born to women who didn’t take antidepressants during early pregnancy.

From the Company to Doctors

It is “difficult” to determine whether Paxil caused those birth defects, says GlaxoSmithKline in a letter sent to doctors.

In the letter, the company notes that these findings differ from previous studies looking at birth defects and antidepressants.

Data from the large Swedish Medical Birth Registry hasn’t shown evidence of increased risk of major birth defects with antidepressants, including Paxil, notes GlaxoSmithKline.

GlaxoSmithKline spokespeople were not immediately available for comment.

Paxil’s Warning

Paxil’s official web site puts it this way:

“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.”

Antidepressants, including Paxil and others, such as Prozac and Zoloft, have been linked to withdrawal symptoms in babies born to mothers taking these medications. These antidepressants are known as selective serotonin reuptake inhibitors (SSRIs).

The Paxil web site also 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.

“Like many antidepressants, Paxil can be present in breast milk so tell your doctor if you are nursing.”

Source: WebMD Health News

SOURCE: Paxil and Pregnancy › New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants