Paxil is a medication used to treat depression, anxiety disorders and some personality disorders. Paxil is an SSRI (Selective Serotonin Reuptake Inhibitor) antidepressant. SSRI medications work by increasing the activity of the chemical serotonin in the brain. http://www.mayoclinic.com

The use of antidepressants, such as Paxil, during pregnancy has shown to be dangerous for the fetus. Although not all women who have taken Paxil during pregnancy will experience fetal malformations the risk exists. Paxil use during pregnancy has been linked by many independent studies to birth defects in newborns. These birth defects can range from heart malformations to abdomen malformations.

Studies from many reputable institutions have shown an increased risk of fetal malformation with the administration of SSRIs during pregnancy. A study at Boston University www.bu.edu found that Paxil use was associated with an increased risk of heart defects in newborns. Similarly, studies from the Harvard School of Public Health http://www.hsph.harvard.edu/ and the American College of Obstetricians and Gynecologists www.acog.org have all found that Paxil use during pregnancy can be dangerous for the fetus.

A study conducted by members of the Department of Epidemiology of the Harvard School of Public Health http://www.hsph.harvard.edu/ has found a link between SSRI (Paxil) use and gestational hypertension. The study was conducted to assess the risks of gestational hypertension and preeclampsia while using SSRIs. This study was published in the American Journal of Psychiatry http://ajp.psychiatryonline.org/.

To do this, the researchers looked at 5,731 women with non-malformed infants. These women participated in the Slone Epidemiology Center http://www.bu.edu/slone/ Birth Defects Study from 1998 to 2007. The study conducted by the Harvard School of Public Health researchers looked at the numbers of women who did and did not develop gestational hypertension and preeclampsia in both those who did and did not take SSRIs during pregnancy. Of the 5,731 women studied, 5,532 were not treated with SSRIs. The rate at which hypertension was present in the group which was not treated with SSRIs was 9.0%. Of the 199 women who were treated with SSRIs, 19.1% developed gestational hypertension. The rate of preeclampsia in women who were not treated with SSRIs was 2.4%. The rate of preeclampsia in women who were treated with SSRIs during the first trimester was 3.7% and was 15.2% for women who continued SSRI treatment beyond the first trimester.

The researchers concluded that SSRI exposure during late pregnancy might identify women who are at an increased risk of gestational hypertension and preeclampsia. Nearly every week, more information about the use of SSRIs such as Paxil during pregnancy is being discovered.

The American College of Obstetricians and Gynecologists is known as ACOG. The College www.acog.org warns of the dangers of the use of Paxil by women who are pregnant or plan on becoming pregnant. According to ACOG, the use of Paxil has the “potential risk of fetal heart defects, newborn persistent pulmonary hypertension and other adverse effects.” A further study revealed a startling statistic. According to the study, women who took Paxil during the first trimester increased the risk of cardiac malformations by one and a half times compared to women who did not receive Paxil. http://ctr.gsk.co.uk/welcome.asp

Then yet another study based on Swedish national registry data of delivery outcomes after women used SSRI antidepressants in early pregnancy reported a 2-fold increase in the risk of cardiac defects in infants exposed to paroxetine (Paxil) compared with the general population. http://74.125.155.132/search?q=cache:4IM5zoD6WGsJ:www.gsk.com/media/paroxeti

Birth defects as a result of SSRI use are not limited to heart problems. A study referred to by the Organization of Teratology Information Specialists or OTIS www.otispregnancy.org links the use of Paxil and other SSRIs to omphaloceles (malformations of the abdomen).

Work is ongoing to bring to light the effects of Paxil during pregnancy. Considering that two of our Paxil/pregnancy cases against Glaxo www.gsk.com (the manufacturer of Paxil) are pending, we hope information regarding the effects of Paxil on babies in the womb comes to light.

A second Emory University www.emory.edu psychiatrist has been reprimanded for alleged conflicts of interest between his research and the pharmaceutical company GlaxoSmithKline www.gsk.com. Zachary Stowe was the lead investigator on at least three National Institutes of Health www.nih.gov grants that involve the study of GlaxoSmithKline antidepressants. Stowe’s grants dealt specifically with the use of antidepressants by pregnant women.

A study conducted by Stowe found that Paxil was safe for breast-feeding mothers. We question this as our Paxil baby cases proceed toward trial. Paxil has been shown by studies to be a potential danger for babies in utero. Pregnant women should be interested in the studies.

In 2007, Stowe allegedly received $154,000.00 from Glaxo and in the first 10 months of 2008, he allegedly received another $99,300.00. It appears GlaxoSmithKline has gone to great lengths to influence studies about Paxil.

Recent news reveals that a medical professor at Emory University in Atlanta www.emory.edu allegedly may have been involved in misleading the National Institutes of Health regarding consulting work done for pharmaceutical companies. The professor was the primary investigator in a study funded by the National Institutes of Health www.nih.gov concerning the use of GlaxoSmithKline drugs.

According to an investigation conducted by Emory, Dr. Nemeroff allegedly did not report $800,000 he received from GlaxoSmithKline www.gsk.com. Dr. Nemeroff apparently claimed he did not know he had to report payments for general talks on medicine. Dr. Nemeroff reportedly played a large role in a GlaxoSmithKline program to “to influence clinicians . . . on the benefits of Paxil versus competitors.” The program was also created to “help build Paxil advocacy.”

What does all of this mean to a mother who took Paxil while pregnant? If the facts are as alleged, it means there is a conflict of interest between GlaxoSmithKline and the information Dr. Nemeroff reported to the National Institutes of Health. In other words, GlaxoSmithKline allegedly may be paying Dr. Nemeroff in a round about way so that he will say good things about its drug. If so, the National Institutes of Health and thus the consumer may receive biased information on Paxil.

Considering that there are lawsuits pending against Glaxo, including ours, for mothers and babies, we would hope that any conflicts of interest involving Glaxo and the medical community are brought to light.

If Paxil damaged you or your baby, your case lives on. The drug industry tried to wipe out lawsuits. Drug companies claimed that if the FDA approved the warning the companies put on a drug, that was the end of it and they could not be held liable for a bad warning. But in Wyeth v. Levine, the United States Supreme Court said, ‘not so fast.’

Levine (the patient) lost her arm to gangrene. The evidence showed that Wyeth’s drug, Phenergran, can cause gangrene even when skilled medical personnel administer it and follow Wyeth’s directions. Wyeth knew that because there were 20 similar amputations in the 30 years before Levine’s case.

The issue in her trial was whether improper administration was an intervening cause that cleared Wyeth from its duty to warn that health care providers should not use the "IV push" method. The jury specifically found that the way it was administered, by IV-push, was not an intervening cause. That’s because Wyeth did not warn that administering it by IV push could lead to gangrene.

An intervening cause breaks the chain of causation. That’s lawyer language that says ‘even if the drug was dangerous, the company is not responsible if someone else caused the damage.’ Here, any damage by the intervening health care providers was the result of Wyeth’s failure to warn.

In lawyer words, this jury decided that an intervening cause did not break the causal chain between Wyeth's failure to warn and Levine’s amputation. So she won the trial. But Wyeth appealed, all the way to the United States Supreme Court. That’s good for you because when the Supreme Court got the case, it decided that “preemption’ is not a defense.

Preemption? What’s that? Language in the opinion clarifies that the Federal Drug Administration www.fda.gov through its regulation at 21 CFR 201.80(e) requires a drug manufacturer to warn of a danger "as soon as there is reasonable evidence of an association of a serious hazard with a drug." http://www.access.gpo.gov/nara/cfr/waisidx_08/21cfr201_08.html. The Court held that Wyeth did not need FDA approval to tell the medical community that Phenergran was too dangerous to be administered via IV-push.

Drug companies are required to have adequate concern for the safety and well-being of their customers. Their customers include those we are especially concerned about: mothers whose unborn babies may have been damaged in utero by Paxil.

Defenders of the drug industry cry that the Supreme Court’s decision will curtail drug innovation. That dog won’t hunt. Until the drug companies and their allies tried to invent FDA preemption out of thin air, the state product liability tort system had run smoothly for decades, and drug companies came up with new products all the time.

Contrary to what critics of the Levine decision say, drug manufacturers can do the right thing: start warning when they learn their drug can be dangerous. It’s their choice but you deserve the best information, so they should warn. When they fail, they should pay for the damage they cause.

The first of the cases filed against GlaxoSmithKline alleging the drug caused injuries to unborn children in utero have just been set for trial. These initial trials will be all-important to our clients, of course. The cases arise from expectant mothers who took the antidepressant Paxil while pregnant, which we allege increases a pregnant woman’s risk of having a baby with a birth defect. Those defects, as alleged in court filings, INCLUDE heart problems. A study led by Carol Louik of Boston University found that use of Paxil was associated with an increased risk of a heart defect in a newborn. We look forward to the trials.

Consumers can find information on off-label uses for many drugs if they know where to look. Here’s one link: http://books.google.com/books?id=fhEFkBxEtH8C&pg=PA118&lpg=PA118&dq=%22off+l

In a previous blog, we noted that 1 out of 7 prescriptions is written off-label. Now prescription drugs have become so popular that 1 out of every 4 prescriptions written is off-label. That's a whopping 115 million off-label prescriptions a year.

Typical off-label conditions for which doctors prescribe common anti-depressants include Wellbutrin to treat chronic lower back pain, and Prozac and Zoloft to relieve the symptoms of menopause.

Off-label prescriptions are completely legal and your doctor will tell you, accurately, that they are a vital alternative for optimal patient care. However, there are still risks of side-effects with these medications - no matter what the reason is that they might be prescribed. So consumers need to actively engage in open discussion with their physicians regarding side effects of any medication they might be given.

A recent article shows that 15% or approximately 1 in 7 expectant mothers will experience depression at some level during their pregnancies. http://www.medicinenet.com/script/main/art.asp?articlekey=84213

For mild to moderate depression, treatments such as cognitive therapy may be effective, according to the article. The severity of the depression determines whether a doctor will prescribe anti-depressant medication such as an SSRI. The use of SSRIs in treating depression is common but certain ones such as Paxil have been found to have serious potential risks to the fetus, especially if the mother takes Paxil in the first trimester.

Paxil was more likely to be prescribed for conditions such as anxiety or panic than other SSRIs. Interestingly, babies whose mothers used an SSRI had a much higher rate of echocardiograms in the first year of life when compared to babies whose mothers took nothing.

Selective Serotonin Reuptake Inhibitors are a class of antidepressants used to treat depression, anxiety disorders and some personality disorders. The brain has neurotransmitters, chemicals that act as messengers. These neurotransmitters are made of serotonin, also known as 5-Hydroxytryptamine or 5-HT, chemicals that naturally occur in the human brain.

Two specific areas of the brain have serotonin concentrations, the midbrain and the hypothalamus. These areas regulate mood, hunger, sleep and aggression. The neurotransmitters are released at one point and absorb at another. This is how the chemical message is emitted and received in the body.

Chemical imbalances of serotonin in these areas cause a variety of mood disorders, particularly depression. SSRI medications prolong or inhibit the process by which serotonin is taken up by neurons, thereby maintaining chemical balance in brain. http://psychcentral.com/lib/2006/choosing-the-best-ssri Inhibiting means stopping or retarding a chemical reaction. SSRI medications treat depression by inhibiting the uptake of serotonin, thus making more available for better brain function. www.answers.com/topic/inhibitor?cat=health

Unfortunately, these medications have side effects. www.holisticonline.com/Remedies/Depression/dep_antidepressant-SSRI.htm Side effects can be perilous for an unborn baby by, for example, damaging the fetal heart.

Taking an antidepressant like Paxil may increase a pregnant woman’s risk of having a baby with a birth defect. Although some researchers suggest that the chances appear remote and confined to a few so-called “rare” defects, those defects can be substantial.

The findings appeared in The New England Journal of Medicine. www.nejm.org GlaxoSmithKline www.gsk.com claims that antidepressants are not a major cause of serious physical problems in newborns.

Here’s the problem with these studies: they didn’t include enough cases to adequately assess risks and they didn’t include information on how long women were taking antidepressants or at what doses.

“These are important papers, but they don’t close the questions of whether there are major effects” of these drugs on developing babies. That’s what Dr. Timothy Oberlander said. He’s a developmental pediatrician at the University of British Columbia www.ubc.ca who was not involved in the studies. “There are many more chapters in this story yet to be told.”

In both studies, researchers interviewed mothers of numerous infants with birth defects, including heart valve problems. They found that mothers who remembered being on antidepressants like Paxil while pregnant were at no higher risk for “most” defects than a control group of women who said they had not taken antidepressants. But they are at higher risk for some birth defects.

For example, the study led by Carol Louik of Boston University www.bu.edu found that use of Paxil was associated with an increased risk of a heart defect in a newborn.

Well, we haven’t posted for awhile due to our trial schedule but now we have some time. Here’s the latest.

Consumers need to be actively involved in decision making when their doctors prescribe medications for them. Don't be afraid to ask questions and challenge decisions made by your doctor. If the decisions are good ones, they will stand up to scrutiny.

A case in point is Lisa Collins. Her general practitioner prescribed Paxil for her six months before she became pregnant because she had irritable bowel syndrome and at times felt claustrophobic. This proved to be a catastrophic choice for her son Chase who was born with a serious heart defect, which required open-heart surgery. http://www.houstonpress.com/2006-09-14/news/baby-blues/ As noted in this article, Collins did not suffer from severe depression or any mental illness - yet her doctor chose Paxil as a suitable choice to treat her symptoms.

GlaxoSmithKline's expert witness in our Tobin trial in Cheyenne testified that general practitioners have insufficient training to take the detailed history required before prescribing Paxil. Consumers need to be alert for problems that the prescribing doctor does not heed.

A Harvard Medical School professor, Dr. Blumenthal, revealed the likelihood of a physician using a particular drug company’s brand of medicine in exchange for free gifts. Those gifts could lead doctors to prescribe brand-name drugs, when less expensive generic versions may be just as effective. Should these gifts influence doctors who prescribe medications, especially those to pregant women?

Here are some examples of how the gift system works. A medical student walked into the office of a medical practice and found food, trinkets, pens and coffee mugs being handed out to the whole office staff, courtesy of Merck & Co. The physician who was the number one prescriber of Vioxx in his entire region that year, was ‘awarded’ a pair of Philadelphia Eagles season tickets. Vioxx’s party ended with the painkiller getting yanked from the market because it could cause heart problems. Investigations revealed that Merck marketers had misled physicians, wrongly suggesting that Vioxx was better for the heart than other pain relievers, even after research suggested possible dangers. See Stephen Cha’s article, These Gifts Are Bad for Our Health http://www.washingtonpost.com/wp-dyn/content/article/2005/07/22/AR2005072202220.html

A professor of social medicine, David J. Rothman, at Columbia University Medical Center opines that $13,000 per physician is spent annually by drug companies in their effective marketing tactics aimed at getting physicians to do what each drug company wants - to prescribe their product. See the article by Ceci Connolly, Distance sought Between Doctors and Drug Industry http://www.biopsychiatry.com/bigpharma/doctors-drugcompanies.html

A United States Senator, Charles E. Grassley of Iowa www.senate.gov, recently said the treatment of certain doctors at the United States Food and Drug Administration www.fda.gov reveals a pattern showing that the FDA needs to be reformed. The latest doctor the FDA abused is Dr. Rosemary Johann-Liang. She left the FDA last Friday after rough treatment for rubbing some people the wrong way over the FDA’s handling of Avandia. www.nytimes.com She wanted the FDA to require a Black Box warning more than a year ago.

As you know, this blog now focuses on newly discovered issues about Paxil, pregnancy and related heart problems in babies. However, we recall the 2003 treatment of Dr. Andrew Mossholder. This doctor discovered that SSRI antidepressants caused suicidal ideation in some children.

The FDA started a criminal investigation after Dr. Mossholder’s findings leaked to a reporter. The agency then wouldn’t let him speak to an advisory committee about his findings. It hired a team of researchers from Columbia University to reanalyze Dr. Mossholder’s data. But guess what? That esteemed team concluded that Dr. Mosholder was right. Part of this sad story is that the re-analysis took a year. Before then, we proved at trial in the United States District Court in Cheyenne, Wyoming, that Paxil could cause death. But what happens to doctors who question the FDA?

Let’s contrast Dr. Johann-Liang’s treatment with another brave FDA doctor, Dr. Frances Kelsey. John Fitzgerald Kennedy presented her with the President's Award for Distinguished Federal Civilian Service in 1962. http://www.lib.umich.edu/govdocs/jfkeo/eo/10979.htm And for what? She was an FDA inspector who demanded evidence of the safety of thalidomide. Nowadays, the FDA is overruling doctors who stand up to big business and ask for evidence of safety – by punishing the doctors and pushing them out of the agency.

What would you like to know about the doctors who are studying the SSRI anti-depressant drugs being prescribed during pregnancy? Would you want to know if any of them had criminal fraud convictions?

Doctors in private practices study drugs for Big Pharma. Their backgrounds are important to pregnant women and babies throughout America. But there is no national database that makes background records on them publicly available. You cannot get them, except in one state, Minnesota. See http://www.state.mn.us/portal/mn/jsp/home.do?agency=BMP if you’re interested.

In Minnesota alone, the drug industry has paid more than 100 doctors to study drugs who have been disciplined or criticized by the state medical board. At least two of them have criminal fraud convictions.

One of the doctors that Minnesota disciplined, Dr. Faruk Abuzzahab, is a Minneapolis psychiatrist. He says the drug makers were aware of his record but have hired him anyway. He says he helped study Paxil, for instance.

He is still overseeing drug testing on patients and pharmaceutical companies are still paying him. Up to twelve drug companies have paid him for research or marketing since he was disciplined. And would you like to know what he was disciplined for?

Ten years ago, Minnesota’s Board of Medical Practice accused him of a “reckless, if not willful, disregard” for the welfare of 46 patients. Of those, 5 died while under his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that. But that hasn’t kept the drug industry from paying him to study drugs. We wonder how many more like this doctor are on the payroll of Big Pharma.

Here's a quick note on a Friday afternoon. An excellent source of information about pregnant women who want to know about the effects of Paxil on babies is www.babycenter.com That website dicusses topics related to birth defects and antidpressant medication that we have covered in this blog. Go to www.babycenter.com/expert/pregnancy/prenatalhealth/2343.html for a good article in Q&A format.

Considering Paxil's apparent link to heart problems in babies, what can be done to spread the word to doctors. We hope information about this link gets more attention. In light of a recent Canadian report showing that drug regulatory agencies’ warnings of the heightened risk of suicides linked to some antidepressants like Paxil were nearly all ignored by doctors who prescribed these medications, it may be that pregnant mothers may have to do their own homework.

Dr. Paul A. Kurdyak, from the Centre for Addiction and Mental Health in Toronto, and colleagues performed a time-series analysis of new antidepressant prescriptions in Ontario between 1998 and 2005. The American Journal of Public Health published the report online. www.ajph.org

Earlier, the UK Committee on Safety of Medicine released a report cautioning doctors against prescribing Paxil to patients under the age 18, thus bringing attention to the antidepressant suicide risks. Then, the U.S. Food and Drug Administration www.fda.gov issued a similar drug advisory of selective serotonin reuptake inhibitors (SSRIs)—a particular class of antidepressants—in young patients. In September 2005, the FDA expanded the warnings to include the risks to an unborn fetus if the mother takes Paxil.

Kurdyak's team examined computerized prescription records of the Ontario Drug Benefit program. Investigators performed a time-series analysis of new antidepressant drugs to find trends in antidepressant prescription coverage that would indicate whether or not agency advisories were being taken seriously.

Kurdyak’s team found that of all five advisories of the increased risk of suicidal thoughts and behaviors linked to antidepressants, only the first warning resulted in change—new Paxil prescriptions for patients under 20 years of age dropped by 54 percent. Otherwise, prescription patterns did not change for any other individual or class of antidepressants in any age group. http://www.nlm.nih.gov/medlineplus/news/fullstory_45944.html No other antidepressant prescription patterns altered, indicating that physicians overlooked the risks.

The fact that the warnings are not necessarily persuading doctors is a serious cause for concern. Both the FDA and American College of Obstetricians and Gynecologists www.acog.org recommend that public should sit with doctors to talk about the risk of taking antidepressants like Paxil.

The easiest route for a pill to take from the manufacturer to the patient may be through gifts and sample medicines that doctors receive from pharmaceutical companies. A New England Journal of Medicine www.nejm.org study http://freeinternetpress.com/story.php?sid=11542 revealed some types of relationships between the doctors and the drug industry from the 94% of the physicians who responded to the survey.

Physicians admitted to getting meals from company representatives (83%), free drug samples (78%), reimbursements for the costs of attending educational conferences hosted by drug companies (35%), fees for consulting, speaking engagements and enrolling patients in clinical trials (28%), tickets to cultural and sporting events (7%), and so on. You can read Joseph Pereira's article, Gifts to Doctors Are Widespread at www.wsj.com.

Paxil’s maker, GlaxoSmithKline, has been one of the pharmaceutical companies promoting its place with depression patients. Would you expect a doctor having close ties with drug manufacturers to be sensitive toward side effects and to look into them before prescribing? Of course, you would, and you would hope for objectivity. But did you know that the pharmaceutical industry itself estimates that it spends about five billion, seven hundred million dollars ($5,700,000,000.00) every year on marketing directly to physicians? That an average of $6,000 to $7,000 per doctor, so you know some are getting much more. www.washingtonpost.com/wp-dyn/content/article/2005/07/22/AR2005072202220.html

What about your doctor? Almost all doctors are of course conscientious and have your best interests at heart. But you should know about the role marketing may play in your health care provider’s choice of medications to treat you. They may have side effects that a pregnant woman, for example, would want to know about before they affected her baby.

Past posts to this blog show evidence that a baby born to a mother who tool Paxil during pregnancy are at risk for heart defects. In addition, a Canadian study has found that a number of women who took Paxil during the last trimester of their pregnancies gave birth to babies that went through withdrawal symptoms. http://citypages.com/databank/23/1141/article10788.asp.

A study investigating the prenatal effects of SSRIs on neurobehavior of newborns found prenatally exposed infants to be hyperactive, tremulous and with behavioral state abnormalities., http://pediatrics.aappublications.org/cgi/reprint/113/2/368 (Zeskind, P. S., & Stephens, L. E. (2004), Maternal selective serotonin reuptake inhibitor use during pregnancy and newborn neurobehavior).

Eduard Bercovici’s research indicated that children prenatally exposed to SSRIs scored lower on psychomotor (Bayley Scales of Infant Development test) and lower on the motor quality factors (Bayley Behavioral Rating Scale). You can download the article at www.oadd.org/publications/journal/issues/vol11no2/download/bercovici.pdf (Eduard Bercovici, Prenatal and Perinatal Effects of Psychotropic Drugs on Neuro-cognitive Development in the Fetus, Journal On Developmental Disabilities)

GlaxoSmithKline’s (GSK’s) steady addition to the list of disorders Paxil is supposed to treat and an energetic campaign for its use have lead to an astounding increase in the number of users. There are an estimated 3,000 to 5,000 new users every day. In 2001, doctors wrote about 25 million new prescriptions for Paxil. Some of those were for pregnant women. However, GSK did not tell them or their doctors about the risks of defects, including heart defects, in unborn babies. How does this happen?

Drug companies are really good at getting doctors’ attention. Here are some ways they do it. There’s a new study by a team of researchers from Harvard www.harvard.edu, Yale www.yale.edu and the University of Melbourne www.unimelb.edu.au. This study polled doctors across the United States by sending questionnaires to 3,167 physicians. Responses came in from 1,662 physicians. And what did they show?

Almost all the doctors (94%) acknowledged that they had accepted some form of gifts or money from pharmaceutical and medical-device manufacturing firms. What kinds of gifts and money? 83% allowed company representatives to treat them to meals; 78% took free drug samples; 35% accepted reimbursements for the costs of attending educational conferences hosted by drug companies -- in some cases including travel, food and lodging. www.wsj.com. Here is what we’d like to know: Over dinner, or when handing samples to the doctors, were the doctors told about any risks of the drugs, so they could inform their patients?