paxilandsuicide News

Off-Label Prescription Uses Grow

Jim Fitzgerald

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.

Echocardiograms for the Newborn

Jim Fitzgerald

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.

How Do SSRI Medications Work?

Jim Fitzgerald

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.

Babies and Risks of Paxil

Jim Fitzgerald

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.

Heart Surgery for a Baby

Jim Fitzgerald

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.

Gifts to Doctors-Damages to babies?

Jim Fitzgerald

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

From Medals to Troubles - The FDA's Path

Jim Fitzgerald

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.

Big Pharma Paying Convicted Doctors To Test Drugs For Mothers?

Jim Fitzgerald

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.

Source Of Information - Effects of SSRI Medications During Pregnancy

Jim Fitzgerald

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.

Doctors Ignoring Drug Risk Warnings?

Jim Fitzgerald

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.

Pharma’s Gifts: Doctor’s gain? Patient’s pain?

Jim Fitzgerald

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.

More Effects of Paxil on the Unborn

Jim Fitzgerald

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)

Why So Many Scripts?

Jim Fitzgerald

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?

Paxil in the 2d Trimester – Newborn PPH

Jim Fitzgerald

Here is some updated information on the topic of Persistent Pulmonary Hypertension in the newborn baby. Not only must pregnant women be concerned with possible heart defects in the baby, but also we are learning that PPHN is a potentially fatal lung condition. It occurs shortly after birth. A baby with PPHN cannot take enough oxygen into the bloodstream because high pressure in the blood vessels of the lungs blocks it. While many of ours posts are related to the first trimester of pregnancy, there is now information about the risks in taking Paxil in the second trimester and it relates to PPHN. As you know from a past post, the New England Journal of Medicine published a study (Feb 9, 2006), that found that taking SSRI antidepressants, including Paxil, after 20 weeks of pregnancy increases the risk of the baby being born with Persistent Pulmonary Hypertension (PPHN). The direct link is http://content.nejm.org/cgi/content/abstract/354/6/579

It is good that this second-trimester concern about PPHN is drawing attention. Previously, there were reports that late-term exposure to SSRIs can result in withdrawal symptoms such as irritability, difficulty feeding, and difficulty breathing for the mothers of the infants. http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm As you know, we recommend seeking additional information about possible PPHN in newborn babies of mothers who took SSRI antidepressants during pregnancy.

Risks of Birth Defects vs. Treatment of Depression

Jim Fitzgerald

Pregnancy has historically been viewed as a time when depression lifts. Women of reproductive age have the highest prevalence of major depressive disorders, with the American College of Obstetricians and Gynecologists www.acog.org experts estimating that about 1 in 10 will experience a bout of major or minor depression sometime during pregnancy or the postpartum period. Some women choose to keep taking antidepressants like Paxil throughout pregnancy.

The FDA www.fda.gov has strengthened its warnings about possible birth defects in babies born to women taking Paxil during pregnancy. www.fda.gov/bbs/topics/NEWS/2005/NEW01270.html. The question then is “Is it safe for women to stop taking Paxil?” The answer may be “No”.

Those who stopped taking antidepressants or altered their doses were more likely to have a relapse of major depression during pregnancy. www.fda.gov/bbs/topics/NEWS/2005/NEW01270.htmlwww.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm. A study published in the Journal of the American Medical Association (JAMA, February 2006) found that discontinuing the medication had an impact on the risk of a relapse. Lee Cohen, MD and colleagues studied 201 pregnant women whose depression had been lifted by antidepressant drugs for at least three months before their last menstrual period. About six in 10 women who stopped taking antidepressants or lowered their doses due to their pregnancy started taking antidepressants again while still pregnant. They still reported more depression than those who never quit taking antidepressants, the study showed. ACOG, in the news release, while stating that women who are pregnant or planning on becoming pregnant should avoid the use of Paxil when possible because of the high risk of birth defects, including PPHN, also acknowledged that the potential heightened risk for birth defects must be weighed against the risk of relapsing into depression for pregnant women who discontinue their antidepressant 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. www.forbes.com/forbeslife/health/feeds/hscout/2006/11/29/hscout536339.html

The risk of relapsing into depression is also a serious cause for concern, leaving expectant mothers to decide whether the benefits of Paxil outweigh the risks associated with it. Unfortunately, one of the risks that has been identified is damage to the unborn baby. GlaxoSmithKline should warn women who are pregnant or may become pregnant of these risks so that they can seek informed health care.

Women, Depression, Babies & Off-Label Prescriptions

Jim Fitzgerald

One of every seven prescriptions for common drugs are for off-label uses lacking scientific support suggests a study. See www.fool.com/investing/dividends-income/2006/12/22/is-offlabel-offbase.aspx

Paxil is not approved for use in children, but doctors can prescribe drugs as they see fit and routinely recommend antidepressants for children suffering from depression and other psychological disorders.

Dr. Gleason, 53, is a Maryland psychiatrist. He was arrested and charged in connection with promoting a drug for purposes other than those approved by the federal government. At hundreds of speeches and seminars, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. www.nytimes.com/2006/07/22/business/22drugdoc.html?ex=1311220800&en=eeafd3a0752f4924&ei=5088&partner=rssnyt&emc=rss

Nearly a year ago, the U.S. Food and Drug Administration (FDA) and GlaxoSmithKline -- which makes Paxil -- changed the warnings on the drug to include the results of the studies. The FDA then advised pregnant women to merely switch from Paxil to another SSRI drug. A 2005 study showed major birth defects in babies born to women who took this antidepressant during the first three months they were pregnant. An article at www.nytimes.com discussed the study showing twice as many birth defects when mothers were on Paxil, compared to other SSRI drugs.

Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drug’s sales, so companies often evade the rules by funding seminars where doctors are paid to make presentations promoting their drugs, including the “off label” uses.

Lawsuits Against Big Pharma

Jim Fitzgerald

More than 6,000 lawsuits have been filed in recent years against drugs taken by millions of patients: hormone-replacement drug Prempro, birth-control patch Ortho Evra, anti-psychotic Seroquel and anti-seizure drug Neurontin. These lawsuits raise questions about whether drug makers and the FDA pay enough attention to patient safety. Added to the list is Paxil.

Paxil is manufactured by Pharma giant Glaxo SmithKline. Paxil is approved for the treatment of depression, generalized anxiety disorder, social anxiety disorder, panic disorder, obsessive compulsive disorder, and posttraumatic stress disorder in adults.

A 2005 study showed major birth defects in babies born to women who took this antidepressant during the first three months they were pregnant. An article at www.nytimes.com discussed the study showing twice as many birth defects when mothers were on Paxil, compared to other SSRI drugs.

Paxil is an antidepressant drug belonging to a class of medications known as selective serotonin reuptake inhibitors (SSRIs). Paxil is believed to be very addictive, and many users report severe withdrawal symptoms after discontinuing use. Some experts (and a jury in Cheyenne, Wyoming) have linked Paxil to an increased suicide risk.

Glaxo SmithKline Corporation, the manufacturer of Paxil, has been accused of misleading the public and the medical profession by downplaying side effects of the drug. In response, many victims have banded together and filed lawsuits against Glaxo SmithKline Corporation.

Persistent Pulmonary Hypertension of the Newborn (PPHN)

Jim Fitzgerald

The initial warning of the FDA was not to prescribe Paxil to women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate. www.fda.gov/cder/drug/advisory/paroxetine200512.htm However, the New England Journal of Medicine (Feb 9, 2006), based on a retrospective case-control study, found that taking antidepressants, including Paxil, after 20 weeks of pregnancy, i.e., in the second trimester of pregnancy, increases the risk of the baby being born with Persistent Pulmonary Hypertension (PPHN). PPHN is a potentially fatal lung condition that occurs shortly after birth. Babies with PPHN are not able to get enough oxygen in their bloodstream because of high pressure in their lung blood vessels.

More specifically, according to the authors of this study, the risk of PPHN is six times greater in women who take an SSRI antidepressant after the 20th week pregnancy. In women who do not take SSRIs, the rate of PPHN is one or two per 1000 live births. A statement on the FDA's website states, "Neonatal PPHN is associated with significant morbidity and mortality." This concern about PPHN is in addition to previous reports that late-term exposure to SSRIs can result in withdrawal symptoms such as irritability, difficulty feeding, and difficulty breathing for the mothers of the infants.

We recommend seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy.

Pregnant Women, the FDA and Warnings

Jim Fitzgerald

Word is getting out about the risks to an unborn fetus if the mother takes Paxil. The wheels sure grind slowly, though. The initial FDA www.fda.gov warning for women expecting a baby was in September 2005. The FDA based its warning on two studies, the first of which found double the risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared to the risk in the general population.

Three months later, the FDA ordered GlaxoSmithKline www.gsk.com to reclassify Paxil from a Category C to D (a stronger warning) for pregnant women. Category D means studies in pregnant women demonstrated this risk to the unborn baby. The most common defects were cardiovascular, or heart problems.

It took another year for the American College of Obstetricians and Gynecologists (ACOG) www.acog.org to get around to issuing its own warning. Finally, the ACOG Committee on Obstetric Practice recommended that paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible, due to these risks. You can see the warning at www.acog.org/from_home/publications/press_releases/nr12-01-06-1.cfm.

Why do doctors prescribe Paxil to pregnant women?

Jim Fitzgerald

A past post talked about reports about how Paxil may be linked to baby heart defects. Why are expectant mothers prescribed Paxil? For one thing, advertising influences medical choices, leading some pregnant women to ask for Paxil by name. Since 1997, when the FDA www.fda.gov changed the advertising rules, ads for depression medications have moved on from the respected medical journals to television and magazines. When the drug industry knows that 800,000 women per year suffer some form of depression during pregnancy, that’s a huge market to tap. But what about telling pregnant mothers taking Paxil about the risks of birth injuries and congenital heart malformations in their babies.

Public Citizen www.citizen.org is a non-profit consumer advocacy group. Its Dr. Peter Lowry has testified that direct-to-consumer ads are a problem. He described how the drug industry got the power to advertise without disclosing all the side effects: “It was made to seem as if it was some ordinary regulatory step but in fact, it just totally opened up the flood gates and television has never been the same.”

These kinds of ads came under scrutiny during hearings in the U.S. House of Representatives. www.house.gov Dr. Janet Woodcock, the FDA's Deputy Commissioner for Operations, testified http://www.latimes.com that "A lot has happened in the last decade with direct-to-consumer advertising, and we believe it's time to receive additional input.” "It's critical, from a public health standpoint, that the advertisements are truthful and balanced."

But do the ads tell the whole truth? They don’t tell the risks when they can avoid it, and that happens all the time. Through lawyers and public relations firms, Big Pharma’s got quite a lobbying effort going. http://www.sourcewatch.org/index.php?title=Pharmaceutical_Research_and_Manufacturers_of_America Dr. Paul Anthony is Chief Medical Officer at the Pharmaceutical Research and Manufacturers of America. www.phrma.org He says, “Drug consumer advertising is a powerful force that can educate patients and it gets them to go in and have an informed discussion with their physician about their health conditions and treatment options.” When women intend to give birth, they need to know about the risks to their babies if they take Paxil.