Parents blame antidepressant for toddler’s heart defect

March 3, 2007

edition.cnn.com/2006/HEALTH/11/29/paxil.pg/

Parents blame antidepressant for toddler’s heart defect
POSTED: 1608 GMT (0008 HKT), November 30, 2006

• A mom fears the Paxil she took while pregnant caused her son’s heart defect
• FDA says two studies suggest paroxetine, or Paxil, increases birth defect risk
• Paxil’s labeling was changed last year to warn about the risks of birth defects
By Jennifer Pifer
CNN
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BEDFORD, Texas — One of the first things you notice about Adrian Vasquez is the bulge beneath his shirt. It’s a pacemaker, the size of a chocolate-covered Oreo cookie.

Adrian is only 2 1/2 years old.

Born with a double outlet on the right ventricle of his heart, Adrian has endured three open-heart surgeries and countless trips to the emergency room.

His life has been fragile from the beginning. The day after Adrian was born, a hospital chaplain baptized him in the ICU. With a tube in his nose helping him breathe, Adrian’s mother and father sprinkled holy water on his tiny head. He was so weak, they weren’t allowed to hold him. Adrian’s first surgery was three days later, when he was 5 days old. (Watch a boy with a broken heart )

Sitting in their home in suburban Dallas, Texas, Anthony and Matilda Vasquez recently talked about the night their son almost died. Adrian was 5 months old and had just undergone surgery. He had been in the hospital for about a week and seemed to be thriving. In the middle of the night, the young couple got a call.

Adrian was crashing.

They rushed to the hospital. Anthony Vasquez says Adrian was “gasping for air and turning blue.” It took doctors a half-hour to stabilize him. “He pulled out of it,” Vasquez says with fatherly pride.

For a long time, Matilda Vasquez says, she went over in her head every aspect of her pregnancy, trying to figure out whether she did something to cause Adrian’s heart problems. She says she didn’t smoke, didn’t drink, exercised and watched her diet. She says she didn’t even want to take aspirin for fear it would hurt the baby. However, she was taking the antidepressant Paxil when she got pregnant. She says she asked her doctor about it and after checking the labeling, he said it was safe for her to keep taking it.

But late last year, Anthony Vasquez heard something on television about Paxil, heart problems and babies. He checked the Internet and found a warning from the Food and Drug Administration. It said early results from two studies suggested women who took Paxil during the first three months of pregnancy were 1.5 to 2 times as likely to have a baby born with a heart defect as women who received other antidepressants or women who didn’t take antidepressants.

Paxil is made by Glaxo Smith-Kline. A company internal study released in 2005 and shared with the FDA found a 1.5 times increased risk for heart malformations for Paxil compared with other antidepressants. Normally, the risk of giving birth to a child with a heart defect is about 1 percent.

At the urging of the FDA, Glaxo Smith-Kline changed Paxil’s labeling in September 2005 to warn about the risks of birth defects.

Adrian’s parents were furious. They believe Glaxo Smith-Kline was aware of the drug’s risk before he was born in April 2004 and didn’t do enough to warn doctors or expectant mothers. In July, the family sued the company. Glaxo Smith Kline declined to comment on the lawsuit, but in a written statement said it has diligently monitored the safety of Paxil before and after its approval by the FDA in 1992.

The American Medical Association estimates about 40,000 women take antidepressants while pregnant. Weaning a woman off an antidepressant while pregnant can be excruciating. Many doctors we spoke with say the pros often outweigh the cons.

On Wednesday, the American College of Obstetrics and Gynecologists Committee on Obstetric Practice recommended that the use of paroxetine, or Paxil, among pregnant women or women planning to become pregnant be avoided, if possible. The group also said that treatment with with all SSRIs or selective norepinephrine reuptake inhibitors or both during pregnancy be judged on a case by case basis.

But Matilda Vasquez believes expectant mothers should have all the information so they can make the decision for themselves. She says had she known about the possibility of heart defects, she would have stopped taking Paxil.

These days, Adrian spends a lot of time at the doctor’s office. He is behind developmentally and communicates on the level of a 9-month-old. His big brother, Isaiah, often “translates” for his parents and grandparents. It breaks his father’s heart to think that Adrian will never be able to do “boy things” like roughhousing or playing soccer.

When it’s not too hot, Adrian and his brother “drive” around the family’s back yard in a child-sized electric truck. The boys smile and squeal as their dad follows. Matilda Vasquez smiles at her family, but there is also a longing in her eyes. “Adrian will never have a normal life,” she says. “I just hope this lawsuit will just warn people and let them see what an innocent baby can go through.”

Jennifer Pifer is a senior producer with CNN Medical News.

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PaxilDefects.Com

March 3, 2007

www.paxildefects.com/

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Vickery & Waldner – Trial Lawyers
Paxil Drug Litigation Attorney
Only Attorneys in USA to win Jury Verdict in Paxil case

Do you suspect that an antidepressant may have caused a birth defect, serious personal injury, wrongful death or suicide? If so, you may wish to file a product liability lawsuit against the pharmaceutical manufacturer whose negligence resulted in injury or death. Contact us to learn more.

Vickery & Waldner is a Houston, Texas law firm on the forefront of the highly specialized and ever-adapting field of pharmaceutical liability litigation. Our attorneys, while licensed to practice in Texas, are able to handle cases on a national scale. We have the knowledge, skills and resources necessary to help clients take on major pharmaceutical companies in pursuit of justice.

Skilled Drug Lawyers
Much of our drug litigation practice has been focused on the Paxil, which is a SSRI-class antidepressant. Paxil is used primarily to treat depression and anxiety. However, studies have shown that Paxil can have potentially devastating side effects, including suicidal and homicidal tendencies. In June 2001, a jury in our Tobin case found that Paxil can cause some people to become homicidal and/or suicidal. It is the only Paxil case to go to trial in this country. In 2005, GSK warned that women using Paxil during the first trimester of pregnancy are at double risk to give birth to an infant with a congenital heart malformation.

If you have been affected by an unsafe or defective pharmaceutical, you may be entitled to recover compensation for physical, emotional, and financial damages. Call (866) 76-PAXIL for more information.

Experienced Paxil Drug Litigation Attorneys
Vickery & Waldner garnered national media attention in 2001 when a jury ruled in favor of our client, Tim Tobin, who filed a lawsuit against Paxil manufacturer GlaxoSmithKline. Mr. Tobin’s wife, daughter and mother-in-law were killed by his father-in-law, who went on a Paxil-induced rampage just two days after being prescribed the antidepressant. The case remains the only instance in which a plaintiff won a lawsuit against an SSRI manufacturer.

Firm founders Andy Vickery and Paul Waldner have more than 60 years of combined law practice and extensive trial experience. Both are members of the invitation only American Board of Trial Advocates (ABOTA). Our firm is so committed to trying cases that we have our own on-site courtroom. We use advanced video conferencing technology to communicate with out-of-state clients.

Contact Us for More Information
At Vickery & Waldner, our trial lawyers have extensive experience in the highly specialized arena of pharmaceutical litigation. All cases are handled on a contingent fee basis: we do not recover a fee unless you recover compensation in your case. Contact us to learn more about our unique and effective legal approach.

Vickery & Waldner is a Houston, Texas based law firm whose Paxil and anti-depressant litigation practice is national in scope. While we are licensed to practice in Texas, we advise clients throughout the country. We handle cases from New York City to Los Angeles; Boston, Massachusetts to Seattle, Washington. We have handled drug cases from Cheyenne, Wyoming to Honolulu Hawaii.


FDA warnings Seroxat Defects

March 3, 2007

www.fda.gov/bbs/topics/NEWS/2005/NEW01270.html

FDA News
FOR IMMEDIATE RELEASE
P05-97
December 8, 2005

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Advising of Risk of Birth Defects with Paxil
Agency Requiring Updated Product Labeling

The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.

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.

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.

Additional information concerning today’s announcement is available on FDA’s Web site at:
Public Health Advisory: www.fda.gov/cder/drug/advisory/paroxetine200512.htm and
CDER Information Sheets: www.fda.gov/cder/drug/infopage/paroxetine/default.htm.


New baby alert over Seroxat

March 3, 2007

www.telegraph.co.uk/news/main.jhtml?xml=/news/2005/09/29/nserox29.xml&sSheet=/news/2005/09/29/ixhome.html

New baby alert over Seroxat

By Celia Hall, Medical Editor
Last Updated: 12:49am BST 29/09/2005

A new caution over the anti-depressant, Seroxat, has been issued, advising doctors that it could increase the risk of abnormalities in babies if given to women in the first three months of pregnancy.

In America the product leaflet has already been changed to give the new information and a letter to doctors from the manufacturers, GlaxoSmithKline, has been published on the website of the regulatory authority, the Food and Drug Administration (FDA). In Britain and Europe the regulators are still considering the new data, provided by Glaxo at the end of last month.

Seroxat is one of the most widely prescribed anti-depressants, taken by an estimated 2.4 million people in the UK. The drug is only prescribed to pregnant women who are severely depressed when a doctor decides that the benefit to the women outweighs any risk to the foetus.

Last year the Medicines and Healthcare Products Regulatory Agency said that Seroxat should not be given to children under 18 and doctors have been warned that the drug and others in the same class have been prescribed too freely.

The new data, from a Glaxo study, suggests that the risk of congenital abnormalities and heart abnormalities may be raised among women taking Seroxat compared with other anti-depressants.

“GSK is conducting additional epidemiologic studies to more fully understand these preliminary findings,” the company said.

An earlier independent study of 4,291 infants, from Sweden, found no increased risk of birth defects for women who took Seroxat early in pregnancy.

A spokesman said: “The current product information states that Seroxat (paroxetine) should be used during pregnancy only when strictly indicated. Doctors are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy. Patients who are concerned shouldn’t stop taking their medication without consulting their doctor.”

The new data indicated a four per cent risk of congenital abnormality when the drug was taken compared with a population risk of three per cent and a two per cent risk of heart abnormality compared with a one per cent risk.

A spokesman for the MHRA said: “Previous epidemiological data have not provided evidence of an increased risk of birth defects with SSRI antidepressants such as paroxetine. The MHRA is carefully considering all available data and will seek expert advice from the Committee on Safety of Medicines and issue advice as necessary.”

chall@telegraph.co.uk


Baby Blues : A mothers Story

March 3, 2007

www.houstonpress.com/2006-09-14/news/baby-blues/

Baby Blues
Lisa Collins took the Paxil her doctor prescribed. There was supposed to be no problem with her continuing it during her pregnancy. Now, it seems, there was.
By Todd Spivak
Published: September 14, 2006
Dark blue splotches stained Lisa Collins’s newborn son’s mouth as if he’d gotten messy with a lollipop.

Daniel Kramer

Daniel Kramer

Chase’s daily drug regimen tripled after he had open-heart surgery.

Subject(s): Antidepressants and birth defects
Mom scrubbed Baby clean in the bathtub, but the blemishes would not go away.

The discoloration soon spread to Chase’s tiny fingernail beds — the sign doctors had warned about.

Midway through her pregnancy, doctors told the 27-year-old Friendswood resident to expect complications.

The same ultrasound that revealed she was having a boy also showed the fetus was missing part of his heart. A more detailed X-ray image taken a week later revealed an underdeveloped heart chamber.

Doctors predicted Chase would require surgery within two weeks after delivery, if he survived that long.

Nobody could explain why the baby had congenital heart defects. Neither the mother’s nor the father’s family had any history with such problems.

Months later Collins caught a TV news segment warning pregnant women against using antidepressants. Studies showed they may cause birth defects in developing fetuses.

Collins doesn’t suffer from severe depression or any other mental illness. But six months before becoming pregnant, she complained to her general practitioner in Pearland of irritable bowel syndrome and at times feeling claustrophobic.

Dr. Jackie Lynn Snell prescribed Paxil, a popular antidepressant viewed as a cure-all for all things psychosomatic, from depression to an array of anxiety and compulsive disorders.

After becoming pregnant, Collins asked Snell if she should stop.

“She assured me it was perfectly safe,” the mom says. “I trusted my doctor.”

Collins popped the oval-shaped pills through the end of her first trimester.

On November 2, 2005, Collins had a cesarean delivery at St. Luke’s Hospital. Nurses immediately rushed the baby to the neonatal intensive care unit. For two weeks Chase was hooked to a ventilator and fed through a tube.

“I was tripping over cords trying to hold my baby,” Collins recalls.

Able to breathe on his own, he was allowed to go home.

Here he was, nearly three months old, doing fine. A happy, alert infant with a mop of black hair, he ate slowly but rarely fussed and already slept through the night.

Mom held out hope that the doctors were wrong.

Then Baby turned blue.

In March Collins sued GlaxoSmithKline, the pharmaceutical giant that manufactures Paxil. The suit alleges the London-based company concealed studies and manipulated statistics that revealed the drug’s risks for pregnant women.

“We cannot discuss pending litigation around our products,” says GlaxoSmithKline spokeswoman Gaile Renegar.

Snell is also named in the suit. The 35-year-old general practitioner, currently on sabbatical after giving birth to her own child, contends she did not know about the hazards until the U.S. Food and Drug Administration’s advisory late last year.

“The deed was already done by the time the reports came out,” says her attorney, Jay Henderson, of the Houston firm Cruse, Scott, Henderson and Allen, LLP.

Since December 2005, the FDA has issued three public health advisories concerning Paxil and the threat of congenital heart defects. The regulatory agency changed Paxil’s pregnancy category from C to D, which indicates that there is “positive evidence of fetal risk.”

In addition to heart defects, several medical studies published in the last year have shown antidepressants taken during pregnancy significantly increase the risk of potentially fatal lung conditions and abdominal wall defects in newborns.

The FDA has not approved Paxil or other similar drugs for pregnant women, though they are commonly prescribed to treat depression. More than 40,000 pregnant women in the United States take antidepressants, according to the American Medical Association.

Though it remains too early to know how many families may be affected, the potential result is a new generation of deformed children and guilt-ridden mothers not seen since the thousands of thalidomide babies born in the early ’60s.

Antidepressants such as Paxil were widely touted as wonder drugs with no serious side effects when they entered the market nearly two decades ago. “Sunshine in a bottle,” proponents called them. They have since become increasingly controversial, prompting thousands of lawsuits.

These suits have fallen into two main camps. One alleges the drugs are addictive and can produce severe withdrawal symptoms including hallucinations, extreme mania and electric-shock sensations. The other claims they may actually cause depression and trigger suicidal and homicidal behavior.

Collins’s case is among the first of its kind and marks the start of a new trend in litigation against antidepressant makers.

Dallas-area residents Anthony and Matilda Vasquez have filed the only other similar lawsuit in Texas. Their two-year-old son, Adrian, has undergone three open-heart surgeries and has a pacemaker. The mom took Paxil during her entire pregnancy.

These cases may attract international attention; the Collins suit is the first in the country to already have a trial date, set for next summer.

The FDA approved Paxil to treat depression in 1992 as part of a new class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.

It has long been believed that SSRIs work by boosting serotonin levels, the brain chemical most closely associated with depression. Drug makers and several leading scientists say this helps normalize cell-to-cell communication in the brain, stabilizing the chemical imbalance thought to cause depression.

Recent studies cast doubt on this theory, suggesting that scientists have never understood the drugs’ effects on the brain.

A growing number of medical researchers say while increasing serotonin retention, SSRIs also indirectly inhibit the neurotransmitter dopamine, causing a chemical imbalance in some users. This has been linked to serious side effects such as akathisia, a severe inner restlessness associated with violent behavior.

Illegal hallucinogens such as ecstasy, LSD and PCP similarly increase serotonin levels and decrease serotonin metabolism.

SSRIs were considered a vast improvement over previous generations of antidepressants, developed in the ’50s and ’70s, which were found to elevate moods but later deemed acutely toxic with a high risk of overdose.

he first SSRI introduced in the United States was Eli Lilly’s Prozac in 1988. Its immediate popularity led to a host of brand-name imitators, from Paxil to Pfizer’s Zoloft, Forest Laboratories’ Celexa, Solvay Pharmaceuticals’ Luvox, Wyeth Pharmaceuticals’ Effexor and many others.

Daniel Kramer

Houston attorney Robert Kwok plans to file multiple lawsuits against antidepressant maker GlaxoSmithKline.

Photos courtesy of Cassandra Burdick

Cassandra Burdick holds son Nicholas…

Subject(s): Antidepressants and birth defects
All are marketed to treat a range of mental illnesses, including severe depression, post-traumatic stress disorder, social anxiety and obsessive-compulsive disorder. Doctors prescribe them for everything from eating disorders to bed wetting, low self-esteem, nail biting and shyness.

More than 20 million Americans take antidepressants. Last year doctors dispensed 150 million prescriptions in the United States, according to IMS Health, a Connecticut-based health care information company. As much as 70 percent of the drugs are prescribed not by psychiatrists but by general practitioners with no special training in complex mental disorders.

The overall market for antidepressants in the United States exceeds $12.5 billion annually. Sales of Paxil earn GlaxoSmithKline $3 billion a year worldwide.

The debate over SSRIs has raged for 20 years. Drug companies and countless patients who swear by them have been quick to dismiss any suggestion that they may be harmful. Then there are doctors and attorneys who blame the drugs for virtually every seemingly unexplainable violent rampage.

Harvard Medical School psychiatrists were the first to identify a link between SSRIs and aggressive behavior, reporting in 1990 that six adults experienced “intense, violent suicidal preoccupation” within a couple of months of starting Prozac.

An FDA panel dismissed the study. It took 15 years for the agency — which some criticize as more lapdog than watchdog — to change its thinking.

FDA drug-safety analyst Andrew Mosholder in 2003 discovered several suicide attempts reported in Paxil trials under the euphemistic heading “emotional liability.” Mosholder conducted his own analysis of Paxil and other antidepressants. He found they doubled the risk of suicidal thoughts or behavior in children and adolescents compared to a placebo. Several trials further showed they performed no better than a sugar pill.

The FDA blocked Mosholder from going public, claiming that his study had not been finalized. But his findings were soon leaked to the media.

Based on these revelations, the FDA in the summer of 2003 issued a public health advisory warning that Paxil and other SSRIs may worsen depression and cause suicidal tendencies in kids under 18.

In June 2004, New York Attorney General Eliot Spitzer sued GlaxoSmithKline for allegedly burying studies showing Paxil increased suicidal thoughts and behavior in kids. Central to the case was an internal GlaxoSmithKline document showing the company intended to “manage the dissemination of data in order to minimize any potential negative commercial impact.” GlaxoSmithKline denied the charges but settled the suit in August 2004 for $2.5 million and agreed to post its clinical results on the Web.

Later that year the FDA required all antidepressants to carry a black box warning on labels, the agency’s strongest kind, to warn of suicide risk in children. Then in May 2006, GlaxoSmithKline issued a statement warning doctors of a heightened risk of suicide in young adults, ages 18 through 30. It marked the first study released by a drug company that showed a connection between antidepressants and suicidal behavior.

This debate has been argued in scores of lawsuits since the late ’80s, when Prozac hit the market. Antidepressants have been blamed for prompting the Columbine shootings and countless other killing sprees.

Many of these suits were resolved in 11th-hour settlements, enabling drug companies to avoid the publicity of going to court and nix the risk of confronting a guilty verdict.

One high-profile case pitted the family of Joseph Westbecker against Eli Lilly, claiming the Kentucky man’s four-week use of Prozac in 1989 led him to kill eight people. Lilly won the case. But it was later discovered that the drug company doled out huge settlements to all the attack survivors and their attorneys. The judge later changed the official record from a jury verdict in Lilly’s favor to dismissal of a settled case.

In 2001 relatives of Donald Schell sued GlaxoSmithKline, claiming the Wyoming man’s 48-hour use of Paxil in 1998 led him to kill his wife, daughter and nine-month-old granddaughter. The jury found Paxil was a “substantial factor” and ordered the drug company to pay $6.5 million to surviving relatives. It marked the first and only case won by a plaintiff.

Houston trial lawyer Andy Vickery represented the Schell family. He enjoys a national reputation as the lone attorney to stick it to GlaxoSmithKline on the suicide issue.

Vickery and associate Paul Waldner already have consulted with about 70 women who are convinced that taking Paxil during pregnancy caused serious birth defects.

The most commonly reported malformations have been atrial and ventricular septal defects. These are holes in the membrane that separates the chambers of the heart, and often can be surgically repaired.

Vickery and Waldner are in the preliminary stages of filing several lawsuits against GlaxoSmithKline. They are selecting the most extreme and unique cases, all of which required multiple surgeries. In one instance, a baby was born without heart chambers. In another, the aorta and pulmonary artery were conjoined as one vessel.

Vickery points to revelations that GlaxoSmithKline selectively used clinical trial data to play down the risks of violent behavior in Paxil users. He predicts similar information will emerge regarding the dangers to fetuses.

“We gained access to a lot of GlaxoSmithKline documents that are not in the public domain,” says Vickery, whose firm is devoted entirely to antidepressant cases. “We’re not some wild-eyed crazy lawyers blowing smoke.”

Vickery says the first claim linking Paxil with heart defects in fetuses appeared in a 1998 report filed in the FDA’s “adverse effects” database.

In 2003 GlaxoSmithKline began the first major study on the subject, performing a retrospective analysis of pregnant women, dating back to 1995, who had taken antidepressants in the first trimester and had given birth to children with major congenital malformations. The analysis showed a more than twofold increase in women taking Paxil compared to other antidepressants.

At about the same time researchers analyzed data from Sweden’s birth registry, which collects information on pregnant women and offspring, and found birth defects were twice as common among Paxil users.

Based on these studies, the FDA changed Paxil’s labeling.

Meanwhile, new reports continued to surface showing a wider array of health risks for pregnant women taking Paxil and similar antidepressants.

2005 study published in The Teratology Society reported women who took Paxil were more likely to have infants with birth defects such as omphalocele, in which the intestines or other abdominal organs protrude from the navel, and craniosynostosis, the early closing of one or more of the sutures of an infant’s head, resulting in malformation of the skull as well as mental retardation and blindness.

Photos courtesy of Cassandra Burdick

…who died after three months on a ventilator.

Subject(s): Antidepressants and birth defects
A February 2006 study published in The Archives of Pediatrics & Adolescent Medicine examined 60 newborns exposed in utero to SSRIs. Of these, 18 showed mild to severe signs of “neonatal abstinence syndrome,” or withdrawal from the drugs at birth. Symptoms included tremors, high-pitched crying and feeding difficulties.

One week later a study published in The New England Journal of Medicine showed taking antidepressants such as Paxil after 20 weeks of pregnancy greatly increases the risk of having a baby born with persistent pulmonary hypertension. As much as 20 percent of babies born with the disease die soon after birth, while others will have developmental delays, hearing loss and brain abnormalities.

And a report last month in the Archives of General Psychiatry found that babies born to women who took SSRIs during pregnancy face an increased risk of having a low birth weight and developing respiratory distress.

These studies and several others still awaiting publication would seem to offer ample proof that SSRIs and pregnancy should not mix. But many doctors remain unconvinced.

“The evidence is not conclusive,” says Dr. Christina Chambers of the University of California at San Diego, who was the head researcher for the report on persistent pulmonary hypertension.

Chambers led a study ten years ago showing neonatal problems in infants born to mothers using SSRIS but says the risks were not statistically significant compared to the general population. Chambers and many others say the sample sizes in most studies have been too small to be considered definitive.

Houston attorneys Robert Kwok and Sean Tracey, who represent Lisa Collins, are planning a trip to GlaxoSmithKline’s headquarters in Pennsylvania to pore over files.

They face the difficult task of proving the antidepressants caused the deformations in much the same way attorneys had to show the drugs and not the depression were causing violent behavior.

Renegar, the GlaxoSmithKline spokeswoman, is quick to point out that congenital heart defects affect 3 percent of the general population and often have no discernible cause.

Kwok believes there will be strength in numbers.

“The drug company’s not going to be able to deny causation,” he says, “when I have 100 babies lined up with the same problem.”

So what’s a depressed woman in her childbearing years to do?

Doctors remain divided on this question, since depression during pregnancy carries its own risks. Several studies have linked the illness to higher rates of miscarriage, stillbirths, premature deliveries and developmental delays.

“Someone who is severely depressed, who is not getting out of bed, not eating, not tending to prenatal care — I’m going to medicate her,” says Dr. Margaret Spinelli, director of the Maternal Mental Health Program at the New York State Psychiatric Institute.

But Spinelli and others say they may be more inclined to prescribe tricyclics, a previous generation of antidepressants developed in the ’70s not found to cause birth defects.

Psychiatrist and author Peter Breggin, a longtime critic of SSRIs, says it’s hard to get unbiased information about treatment options for depressed pregnant women because of what he perceives as the incestuous relationship between drug companies and the FDA.

In the ’60s the FDA won praise for rejecting approval of thalidomide, a sedative marketed to pregnant women that became infamous for producing birth defects such as flipperlike arms. But that was a different agency, he says, from the one that took 15 years to succumb to evidence of a suicide risk in SSRIs.

In fiscal year 2004 the FDA collected some $250 million from drug companies, nearly half its drug-review budget. At the federal level, congressional committees and the Government Accountability Office recently have criticized the agency for failing to scrutinize drug safety. This summer the FDA announced plans to write new guidelines specifying when scientists and doctors serving on advisory panels should be disqualified because of conflicts of interest.

Further complicating the issue are recent revelations that several doctors considered opinion leaders on the risks of antidepressants have financial ties to drug companies.

In July, The Wall Street Journal revealed that a study published in the Journal of the American Medical Association, which warned that pregnant women who stop taking SSRIs are more likely to relapse into depression, was created by authors paid as consultants and lecturers by makers of antidepressants.

According to Breggin, it should come as no surprise that SSRIs are harmful to fetuses, since the drugs cross the placenta barrier and even enter the breast milk. Paxil, he says, is particularly toxic.

“The drug should not be given to pregnant women, period,” Breggin says. “The fetus is bathed in Paxil. The developing brain and the developing lungs are growing in response to the drug, and that can’t be good.”

A faint, thin scar extends from the base of Chase’s neck to his bellybutton, covering one quarter of his pale little body.

On January 27, 2006, three days after his nail beds turned blue, Chase underwent open-heart surgery at Texas Children’s Hospital. The operation went as well as could be expected.

Two weeks later he unleashed a hair-raising scream from his crib unlike anything his mother had ever heard.

Chase had suffered three consecutive strokes due to a blood clot caused by the operation, a cardiologist later discovered.

Following the strokes, seizures gripped his body, causing his eyes to roll back and his head and limbs to fold forward and convulse. He has since experienced seizures on a near-daily basis.

The surgery saved his life. But it changed him.

Blame it on the stroke, the half-dozen medications he takes daily or a combination of the two, but Chase today often appears catatonic. His facial features drag; his motor skills are delayed, his breathing labored.

Doctors warn he will need repeated heart surgeries. He may one day require artificial replacement valves and a heart transplant.

He is examined monthly by a cardiologist, a hematologist and physical and occupational therapists. He has been rushed to the ER ten times in nine months.

Lisa Collins quit her job as an office manager to take care of Chase full-time. She and the child’s father, 29-year-old Radford Steele, agree that stress over the baby dissolved their five-year relationship.

Last month Collins moved in with her grandparents across from Friendswood High School. A poster hangs in the kitchen, demonstrating how to perform CPR on an infant.

Collins has warned other pregnant women against using Paxil. Since she began publicizing her experiences, several Houston-area women have come out of the woodwork with similar stories and are now working to file their own suits against GlaxoSmithKline.

Cassandra Burdick, a 41-year-old Galveston resident and taxi driver, took Paxil during her first trimester to help level out her mood. Burdick’s doctor assured there was no risk involved. Last June she delivered a boy with no pulmonary artery, among other deformities. Never allowed to leave the hospital, Nicholas died two months later.

“Tubes,” she says. “That’s all he knew his whole life was tubes.”

Despite their better judgment, Collins, Burdick and others hold themselves responsible.

“My baby was cut from top to bottom,” Collins says, “and I may have taken something that caused him to go through all of this.”


Paxil linked to cleft lip

March 3, 2007

www.lawyersandsettlements.com/articles/paxil_cleft_lip.html?ref=case

Paxil linked to Cleft Lip
September 8, 2006. By Jane Mundy digg Del.icio.us
Neosho, Missouri: “I took Paxil when I was pregnant,” says Amee Stauffer. Isabel was born with a cleft lip and had surgery when she was two months old. “Now she is four and kids are already laughing at her.”

“Isabel is going to need more surgery as she gets older and major orthodontics – she has several teeth missing and will need implants. She had surgery to repair the top lip and the plastic surgeon said we have to leave the bottom lip until she is older, so that means it is going to grow.

I read about Paxil and the link to birth defects earlier this year and we thought that Paxil might be the reason for her cleft lip; this is usually genetic and there is no history of cleft palate or cleft lip on either side of our families. Isabel also has deformity on her lower lip that her pediatrician and her plastic surgeon said they have never seen anything like it – it looks like a cleft almost formed on her lower lip.

I did some research about Paxil and mostly found information about heart defects. Then I found that Paxil was also related to birth defects such as cleft lip and cleft palate. I don’t have any idea why this happened to Isabel. So far I haven’t talked to her doctor about any correlation between her birth defects and Paxil. He told me that it was OK to take Paxil while I was pregnant and that it would be better to take it rather than be anxious or depressed – my mental state would outweigh any possible side effects, otherwise I would never have taken it. This is so frustrating and I feel responsible because I chose to take Paxil. But I was also told by my doctor that it was better to take it. Of course I wish I never took it, nobody wants their kids to have to deal with stuff like this.

It really hurts me when Isabel gets laughed at. Most kids are her friends but new friends say to her ‘What is the matter with your mouth,’ and she gets upset. Isabel doesn’t see anything wrong with it, but as she gets older it is going to be a big problem. This worries me, it weighs heavily, especially being a girl and having a birth defect on her face. Now that I know it could have been Paxil, it makes me mad but also helps explain why this happened. I wonder how many other parents out there don’t know that Paxil may have caused birth defects like cleft lip?


Paxil linked with birth defects

March 3, 2007

www.medicalnewstoday.com/medicalnews.php?newsid=31317

antidepressant Paxil Might Be Associated With Birth Defects, Study Says

GlaxoSmithKline’s antidepressant drug Paxil might be associated with birth defects, FDA said on Tuesday, the AP/Philadelphia Inquirer reports. According to FDA and the company, a retrospective study on women who took Paxil during the first trimester of pregnancy found that there were an increased number of infants born with birth defects, including heart defects, when compared with pregnant women who took other antidepressants during their first trimester. The medication is classified as a “Category C” drug for pregnant women, which means comprehensive studies of its effects during pregnancy have not been performed. GSK advised physicians “to carefully weigh the potential risks and benefits of using [Paxil] therapy in women during pregnancy,” adding, “It is recommended that health care providers discuss these latest findings, … as well as treatment alternatives, with their patients.” The company said it has not decided whether a definitive causal link exists between the drug and an increased incidence of birth defects. The company cited a separate study of births that showed no comparable increase (AP/Philadelphia Inquirer, 9/28). However, GSK said it plans to include the findings of the study in the drug’s list of precautions (USA Today, 9/28).