An estimated 16 percent of woman will experience symptoms of depression, known as postpartum depression (PPD), during the first year after giving birth. If left untreated, PPD can have serious consequences for both the mother and her newborn child. The newborn may experience lower APGAR scores, failure to thrive, and poor physical, emotional and behavioral development for the baby.

But more and more attention is being paid to antenatal depression, or depression during pregnancy. Nearly one-fourth of women experience antenatal depression. Maternal depression can lead to poor maternal self-care, increased risk-taking behavior and poor pregnancy outcomes.

Treatment often comes in the form of a pill, or antidepressant. But the APA/ACOG review report indicates that symptoms of depression and antidepressant use during pregnancy may lead to serious problems for the baby, including preterm delivery, low birth weight and birth defects. Weighing the best treatment should be approached individually with each patient.

For example, a recent scientific study indicated that antidepressants taken during the first trimester increased the risk of birth defects. Some drugs, such as Paxil (paroxetine), had even a greater risk of birth defects, in particular defects of the heart, when taken during the first three months of pregnancy.

The report recommends that given the potential for serious consequences from antidepressant use during pregnancy, some women who are pregnant or considering pregnancy should taper or discontinue therapy to reduce their risk. Women who have mild or no depressive symptoms for six months should consider discontinuing treatment with antidepressants before becoming pregnant. For these women, psychotherapy may be a safer treatment plan.

Women with suicidal or acute psychotic symptoms should optimize their therapy and consult with a therapist about adjusting their antidepressant therapy before becoming pregnant. For these women, the risks associated with untreated depression may outweigh the potential harm to the unborn baby. If at all possible, antiepileptic agents, which are often used with patients with severe symptoms of depression and psychosis, should be avoided for the first three months of pregnancy.

The report further encourages women who suffer from depression who are pregnant or thinking about becoming pregnant to discuss treatment options with their physician or trained clinician to ensure a safe and healthy pregnancy.

SOURCE: Paxil and Pregnancy › Treatment guidelines for women before, during pregnancy

“GSK knew it was not safe to take Paxil (during pregnancy) but said nothing,” his parents say in a video on YouTube. Now Manie has a broken heart, and a scar that runs down the center of his chest. He holds a sign against his scarred chest. It reads, “Why?”

“How many more babies will suffer,” they ask. “Answer this, GSK, please.”

In September 2005, a study on infants born to women taking antidepressants, including Paxil, during the first trimester of pregnancy, revealed a greater risk for overall birth defects and an increased risks for heart defects specifically. Following the study, GSK updated the PRECAUTIONS subsection of its label for Paxil to include the risk of birth defects, including heart defects.

“Do the benefits outweigh the risks?” Manie’s parents ask.  “No. Never.”

What’s to become of Manie’s broken heart?

Read more of Manie’s story at bigpharmavictim.blogspot.com

Source: YouTube, jiedgi

SOURCE: Paxil and Pregnancy › Parents ask GSK: ‘How many more babies will suffer?’

Sometimes drugs are essential for the health of the pregnant mother. In those cases, it is imperative for women to discuss their condition with their doctor and weigh the benefits and risks of medication. Drugs taken by a woman who is pregnant most often reach the fetus by crossing the placenta, just as nutrients and oxygen do. When a pregnant woman takes medication, it can cause premature birth by forcefully contracting muscles in the uterus, starve the fetus of nutrients and oxygen thus resulting in an underweight or underdeveloped baby, or cause abnormal development (or birth defects) and even death.

The Food and Drug Administration (FDA) classifies drugs according to the degree of risk they may cause the fetus during pregnancy, as it did with Paxil in 2005 after reports that women taking Paxil during the first trimester of pregnancy had a greater risk of delivery a baby with a birth defect, especially a heart defect. Some drugs are highly toxic and should be avoided during pregnancy. In some cases, doctors may prescribe an alternative medicine that is safer for the unborn baby.

Source: Merck

SOURCE: Paxil and Pregnancy › Pregnant women beware: Some medications can be lethal to fetus

Researchers looked at data collected between 1990 and 1996 from a larger study investigating heart disease risk, and pulled data from 555 women who were 24 years old on average when they gave birth. Researchers studied that data for links between race, preterm birth and pre-pregnancy depressive mood. The data showed that 18.1 percent of the 249 black women gave birth prematurely – at less than 37 weeks gestation – compared to 8.5 percent among the 306 white participants.

The prevalence of pre-pregnancy depression was also higher among black women compared with white women – 9.4 percent compared to 7.2 percent, respectively. Researchers say the findings suggest that a woman’s overall health must be viewed when considering reproductive outcomes.

But it also points to a need for health care professionals to address a woman’s emotional presence especially if she is pregnant or considering pregnancy. Depression during pregnancy can be dangerous for both the mother and her unborn child, leading to poor nutrition; dependence on alcohol, drugs or cigarettes; and suicidal behavior, all of which can contribute to premature birth. Psychotherapy and antidepressants are a viable option but doctors and patients must both be advised of the potential risks that antidepressants carry. Some SSRIs commonly used to treat depression, such as Paxil, can increase the risk of birth defects, especially heart defects, which have led manufacturers like GlaxoSmithKline to include warnings of potential birth defects on the medication’s label.

Source: Reuters

SOURCE: Paxil and Pregnancy › Depressed, black women at higher risk of delivering prematurely

Pregnant women

The study, published earlier this year in the Journal of the American Medical Association, examined more than 11,000 low-income mothers in New Jersey. The data indicated that 9.6 percent of women with diabetes who had no indication of depression during pregnancy, developed depression during the year following delivery.

Researchers say that the findings do not establish that diabetes causes postpartum depression, only that the two are related and that health care professionals should consider the mental health of patients when dealing with low-income individuals with diabetes both during pregnancy and the postpartum period.

About 10-20 percent of women will struggle with some symptoms of depression during pregnancy, and a quarter to half of those will suffer major depression, according to the American Pregnancy Association. Untreated depression can have potential dangerous risks to both the mother and baby, leading to poor nutrition; dependence on alcohol, drugs or cigarettes, and suicidal behavior that can cause premature birth, low birth weight and developmental problems. Add maternal diabetes to the mix, and mothers can feel even more consumed by emotions.

While antidepressants can serve as a viable treatment for depression, women should discuss their options with their healthcare provider. Some SSRI medications, such as Paxil, have been shown to increase the risk of overall birth defects and in particular heart defects, when taken during pregnancy. As of September 2005, Paxil manufacturer GlaxoSmithKline has updated its precautions section on the Paxil labels to warn of the potential risk to babies when taken by mothers during the first trimester.

SOURCE: Paxil and Pregnancy › Women with diabetes more likely to suffer postpartum depression

Dr. Zachary Stowe, director of the Women’s Mental Health Program at Emory, is listed as the primary investigator on at least three National Institutes of Health grants that involve antidepressant use in pregnant women and the effects on children delivered by those women.

According to records, Dr. Stowe received payments totaling more than $250,000 between 2007 and 2008 from drugmaker GlaxoSmithKline PLC, during which time Dr. Stowe delivered at least 95 promotional talks on behalf of the drug company. Dr. Stowe contends his work with GlaxoSmithKline was not a conflict of interest and that such relationships are not uncommon in research.

Dr. Stowe is the second Emory researcher who has been reprimanded for not properly disclosing his financial arrangements with drug companies. Last fall, Dr. Charles Nemeroff resigned as chairman of Emory’s Department of Psychiatry for similar conflict of issues concerns.

Of heightened concern is GlaxoSmithKline’s antidepressant Paxil, which recent studies have shown have a greater risk of causing serious birth defects in the children of women who took the antidepressant during the first three months of pregnancy. As a result, GlaxoSmithKline updated the cautions section of Paxil to indicate the risk of overall birth defects, in particular heart defects.

Sources:
Atlanta Journal Constitution
Wall Street Journal

SOURCE: Paxil and Pregnancy › Psychiatrist reprimanded for taking money from drug maker

The findings are based on a study published in the online journal Fertility & Sterility. It is touted as one of the first studies to investigate the effects of antidepressants on sperm quality. While fertility wasn’t a direct focus of the study, “we can infer that as many as half of men taking SSRIs have a reduced ability to conceive,” says Dr. Peter Schlegel the study’s senior author.

More than a third of participants in the study also reported significant changes in erectile function and ejaculatory difficulties. Both sexual function and compromised sperm DNA returned to normal one month after discontinuation of the antidepressant.

Antidepressants also can have a more serious effect on fertility. Women who take antidepressants during the first trimester of pregnancy are at greater risk of having a baby with serious birth defects. Studies show that while a number of birth defects have resulted from use of antidepressants, paroxetine (Paxil, Seroxat) poses the greatest risk to an unborn child. Those defects include cardiac defects such as ventricular septal defects, pulmonary hypertension, omphalocele, and craniosynostosis.

Those who are pregnant or are considering pregnancy should consult with their doctors about any medications, including antidepressants, they are taking. In some cases, doctors may recommend an alternative that is safer for the unborn child and won’t interfere with conception.

SOURCE: Paxil and Pregnancy › Paxil, Seroxat may interfere with man’s ability to conceive

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

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

One of the most important is to see your health care provider before getting pregnant so that she can evaluate your health and identify any health or lifestyle risks that may affect your pregnancy.

Your doctor will discuss various subjects with you. Here is what the March of Dimes says you can expect during your pre-pregnancy checkup:

1. Family History. A family history includes medical information about you, your partner and your families. If any of you have had birth defects or disorders, you may need to see a genetic counselor to asses any potential risks.

2. Medical Conditions. Some medical conditions, such as epilepsy, diabetes or high blood pressure may require you have special care during pregnancy.

3. Medications. If you take medications to treat any existing conditions, your provider may ask you to change to a drug that’s safer during pregnancy. Some medications taken during pregnancy, such as antidepressants, have been found to cause birth defects in babies.

4. Vaccinations. Chickenpox or rubella (German measles) during pregnancy can harm your baby. Your doctor will encourage you to be up-to-date on your immunizations. If you do not know if you are immune to a disease, your doctor can schedule a blood test to find out. If you need a shot, wait at lest one month after the shot before trying to conceive.

SOURCE: Paxil and Pregnancy › Pre-pregnancy checklist for women considering pregnancy

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

Christine K had been prescribed a combination of Paxil, Risperdal and Depakote five years prior to becoming pregnant. While pregnant she read that Paxil could be harmful to her unborn baby. She asked her doctor take her off the meds, but he insisted she stay on them.

Christine K did more research on the medications and learned that a scientific study on infants born to women taking antidepressants during the first trimester of pregnancy showed that women who took Paxil had a greater risk of birth defects compared to other antidepressants.

As a result of the study, in 2005, GlaxoSmithKline informed health care professionals that it was updating the precautions section of the label for its antidepressant Paxil to include the risk of birth defects and, in particular, heart defects.

In 2006, the Food and Drug Administration (FDA) released another Public Health Advisory based on another study that indicated additional risks associated with taking antidepressants during pregnancy including persistent pulmonary hypertention (PPHN), a serious and life-threatening lung condition that occurs soon after birth, omphalocele and craniosynostosis.

Six months into her pregnancy, against her doctor’s orders, Christine K heeded the warning signs she had read about online and weaned herself off Paxil and the other antidepressants. But the damage had already been done. While her son doesn’t have any of the above mentioned severe birth defects, he does experience sleep problems, aversions to eating, and overall poor health.

“In the first three years of his life, this child has needed more medical care and doctor’s appointments than my other three children combined,” she told the Dissident Voice. “All I can do is watch and wait and hope (his medical problems) resolve on their own.”

SOURCE: Paxil and Pregnancy › Child is helpless victim of mother’s use of Paxil during pregnancy

What Gibson soon realized was that a warning about heart defects in infants born to women who took Paxil during pregnancy was issued the very month her daughter was born.

“I never would have taken the (Paxil) had I been told,” Gibson told a reporter for The Province.

The long, red scar down the middle of her daughter’s chest is a painful reminder of the condition she was unnecessarily born with. She says her daughter’s heart defect has made the little girl prone to infections and stunted her growth.

In 2005, the FDA issued a warning to pregnant women and their doctors to stay away from Paxil because of the increased risk of heart defects in newborns. The agency fell short of banning the medication for pregnant women but stated that it “is advising patients that this drug should usually not be taken during pregnancy.”

The risk of heart defects among newborns is about 1 percent overall. For infants born to women taking Paxil, that number jumps to 1.5 to 2 percent, according to studies cited by the FDA.

SOURCE: Paxil and Pregnancy › Babies born to women taking Paxil at higher risk for heart defects

The families contend that the mothers’ use of Paxil during pregnancy resulted in severe heart defects in their infants and have sued GlaxoSmithKline for failure to warn the public about the dangers of the drug for pregnant women.

The American College of Obstetricians and Gynecologists recently recommended that pregnant women not use Paxil, according to the plaintiffs’ lawyer, Karen Barth Menzies of Los Angeles.

Two of the plaintiffs are from West Virginia, two from Ohio and one from Nebraska.

Source: Lawyers USA

SOURCE: Paxil and Pregnancy › Parents sue Paxil maker for heart defects

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

The family sued the company in state court in Philadelphia for failing to warn consumers of the possible risks of taking the medication during pregnancy, according to the family’s attorney Karen Barth Menzies.

The family is seeking unspecified damages.

Source: Laywers USA

SOURCE: Paxil and Pregnancy › First Paxil birth defect lawsuit filed

The research raises troubling questions about the lack of safety data for many drugs prescribed to pregnant women.

About 8 percent of pregnant women develop high blood pressure, which can lead to a heart attack or stroke.

Exactly how many pregnant women take ACE inhibitors or another blood pressure medication is unclear. However, a national survey found the number of ACE inhibitor prescriptions given to women of childbearing age increased from 1.4 million in 1995 to 2.7 million in 2002, the latest data available.

ACE inhibitors already carry a strong Food and Drug Administration “black box” warning about their dangers in the later stages of pregnancy, and the label says the drugs should be discontinued when pregnancy is detected. But little has been known about their early effects.

Avoid use during pregnancy

Based on the new findings, taking these drugs during early pregnancy “cannot be considered safe and should be avoided,” lead researcher Dr. William Cooper, a Vanderbilt University pediatrician, said in Thursday’s New England Journal of Medicine.

The FDA said more research is needed before it considers changing the warning label to specifically include the risks during the first trimester. But the agency is notifying doctors and patients about the dangers through its Web site.

Doctors said expectant mothers should not stop treatment, because uncontrolled high blood pressure can harm them and the fetus, but should immediately switch to other drugs. Women contemplating pregnancy were advised to ask their doctors about their options.

‘Wake-up call’

“This is a wake-up call. We need to learn more about these drugs to offer better advice to pregnant women,” said Dr. J.M. Friedman, a medical geneticist at the University of British Columbia who had no role in the study.

ACE inhibitors have been on the market for 25 years, but little research has been done on their effects during early pregnancy with the exception of animal experiments and small human studies. The drugs work by relaxing blood vessels and increasing blood flow to the heart.

Last year, U.S. sales of ACE inhibitors topped $3.8 billion, with about 150 million prescriptions filled, according to IMS Health, a pharmaceutical information company. The top-sellers include Lotrel, Altace and Lisinopril.

In the study, researchers studied Medicaid records on 29,507 Tennessee infants born between 1985 and 2000. Of those, 411 had mothers who took a blood pressure drug at least once during their first trimester, including 209 who took ACE inhibitors.

About 7 percent of babies exposed to ACE inhibitors developed major birth defects compared with about 2 percent whose mothers took no drugs or other blood pressure medication, such as water pills, calcium channel blockers or beta blockers.

The most common defects included holes in the heart and neurological and kidney problems.

Researchers found no increased risk among babies whose mothers took another type of blood pressure medication. But they said it is premature to declare those drugs safe to use during early pregnancy.

Finding points to larger problem

“It’s a sobering finding,” said Dr. Robyn Barst, a pediatric cardiologist at Columbia University and spokeswoman for the American Heart Association. “It highlights our lack of data on many drugs that we think are perfectly safe.”

The study was partly funded by the FDA. Three co-authors reported receiving support or fees from Novartis AG or Pfizer Inc. Novartis makes Lotrel. Pfizer makes the calcium blocker Norvasc.

In an accompanying editorial, Friedman of the University of British Columbia said the ACE inhibitor study points to a larger problem about the lack of safety data available on most new drugs when they receive government approval.

The FDA acknowledged it was an imperfect system. Dr. Robert Temple, the agency’s associate director for medical policy, said the government is trying to improve its detection of harmful effects through patient registries and other studies.

“The only way to discover (risks) is through long-term use. That’s a little uncomfortable. It means you only learn about what drugs do to pregnancies after the drug’s been used for a long time,” Temple said.

In the early 1990s, the FDA required pharmaceutical companies to put warning stickers on ACE inhibitors after the agency received a few reports from women whose babies were harmed. The label warned that ACE inhibitors can cause skull deformities, kidney failure, lung problems and even fetal death when taken in the last two-thirds of pregnancy.

Source: AP

SOURCE: Paxil and Pregnancy › Blood pressure pill doubles risk of birth defects

The lawsuit, filed in Pennsylvania state court, is seeking unspecified damages for failing to warn pregnant women about the risks of taking Paxil.

During the last month of her pregnancy, Vasquez learned, while receiving an ultrasound to determine the sex of her baby, that there was something wrong with his heart.

Since then, Adrian has undergone three open-heart surgeries and now has a pacemaker.

The seriousness of these birth defects is such that, at the very first sign of danger, GSK should have issued a strong warning, said attorney Karen Barth Menzies, who is representing the family.

Adrian will need repeated heart surgeries as he continues to grow and may need artificial replacement valves, and perhaps eventually a heart transplant. His prognosis is unclear, she said.

Menzies added that with 40,000 pregnant women nationwide taking antidepressants, thousands of babies are at risk.

Source: Lawyers USA

SOURCE: Paxil and Pregnancy › Paxil Maker Sued Over Child Born with Severe Birth Defects

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

The extent of the heart defects ranged from mild to those that were severe enough to require surgery.

The FDA said that based on the data, it is asking that Paxil’s drug classification be changed from “C” to “D”. Doctors use the classification system to decide whether or not to prescribe a specific drug to a woman who is pregnant.

Despite the warning, the FDA said that Paxil’s benefits may outweigh its risks for certain patients. Paxil is also known by the generic name paroxetine.

The FDA noted that Glaxo (GSK ) had changed its label in September to reflect results from one of the clinical studies. The agency said it now asked the company to update Paxil’s label to now include results from the second study.

In September, Glaxo also sent out letters to health professionals advising of the labeling changes for pregnant women, according to the FDA’s website.

Like many other popular antidepressants, Paxil also carries a warning advising that it can trigger suicidal thoughts in some children and adolescents. The drug is not approved for pediatric use.

Paxil was first approved by the FDA in December 1992.

Source: MarketWatch

SOURCE: Paxil and Pregnancy › FDA strengthens pregnancy warning on Glaxo’s Paxil

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