The organization recently sponsored a British study of 1,400 women and found mothers of multiples (twins and triplets) are almost twice at risk of experiencing symptoms of depressions as mothers of single babies. This, researches say, may be linked to the emotional battles these mothers of multiples face trying to conceive, dealing with IVF treatments or handling the increased risk of miscarriage.

The study also found that one in eight mothers of multiples had to be separated from their newborns shortly after birth because the babies required medical treatment. This separation stirred traumatic emotions in mothers. Tending to a newborn can be exhaustive, and that pressure is doubled – and even tripled – with multiple newborns to care for.

Other factors that can contribute to postpartum depression include socio-economic stress, lack of a stable and supportive family relationships, and the self-imposed pressure many women put themselves under by trying to be the “perfect mom.” Partners of expectant and new mothers are also at increased risk for depression, according to the study.

By screening expectant mothers, BeyondBlue hopes to identify women at higher risk for depression so they can seek treatment sooner. “Long-term untreated PND (postnatal depression) can cause delayed cognitive and emotional development in the baby. The benefits of picking up PND early are immense,” says Dr. Nicole Highet, deputy chief executive for BeyondBlue.

SOURCE: Paxil and Pregnancy › Australian group to screen expectant mothers for postpartum depression

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

For the study, researchers observed a group of 300 pregnant women, most of whom did not suffer from depression but some either had a history of depression or reported becoming depressed during pregnancy. Of those observed, some took medication to treat their depression either for part of their pregnancy or for the entire pregnancy; some did not take medication and remained depressed; and some did not take medication and reported being depressed for only part of their pregnancy.

The research found that the women who took medication for the duration of their pregnancy and the women who did not take medication but still suffered with depression had a much higher rate of premature birth (20 percent) than the women who took no medication and recovered from their depression during their pregnancy (4 to 9 percent).

Antidepressants can also carry others risks to unborn babies. A 2005 scientific study showed a link between birth defects in babies born to women who took antidepressants during pregnancy. The recurrence was rare enough that some antidepressants are still considered viable options for pregnant women.

However, one antidepressant showed a greater risk to unborn children in the first trimester over other antidepressants, Paxil. As a result of the study, drug manufacturer GlaxoSmithKline updated the PRECAUTIONS subsection on the labeling for its popular antidepressant Paxil, citing a greater risk for overall birth defects, in particular heart defects.

Women who are pregnant or are considering becoming pregnant should consult with their doctors to determine what depression treatment is best for them.

SOURCE: Paxil and Pregnancy › Study: antidepressants, depression linked to preterm birth

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

FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus.  Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy.  Women taking Paxil should not stop taking it without first talking with their physician.

The early results of two studies 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 as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.

FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.

Based on results of the preliminary data, GSK updated the drug’s labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.

Source: FDA

SOURCE: Paxil and Pregnancy › FDA Advising of Risk of Birth Defects with Paxil