Yourlawyer.com (Paxil Birth Defects News)

First Paxil Birth Defects Trial A Loss for Glaxo

Wed, 14 Oct 2009 00:00:00 -0700

GlaxoSmithKline has lost the first Paxil birth defects lawsuit to go to trial, with a Pennsylvania state jury ordering the drug maker to pay $2.5 million to the family of a 3-year-old boy. The child was born with heart defects, which his mother attributed to her use of Paxil while pregnant with him.

Paxil is one of a class of drugs known as selective serotonin reuptake inhibitors (SSRI). On two occasions in 2005, the Food & Drug Administration (FDA) requested that the labeling of Paxil be changed to include warnings on three studies that found an increase risk of birth defects. 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). That same year, the FDA also classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

The Philadelphia jury awarded the plaintiffs more than double the $1.2 million they had sought. The jury found 10-2 that Glaxo officials “negligently failed to warn” the doctor treating the child's mother, Bloomberg.com said. It also concluded the antidepressant was a “factual cause” of the child’s heart defects. However the plaintiffs were not awarded punitive damages because the jury did not find Glaxo's handling of the drug to be "outrageous."

As we've reported previously, during the trial, attorneys for the plaintiffs presented internal Glaxo documents, including e-mails and memos, that showed the company's own scientists and executives were aware of Paxil's link to birth defects, yet minimized the risk to doctors. Other evidence presented suggested Glaxo aggressively promoted Paxil for use in pregnant women even after suspecting the risk.

According to the Philadelphia Inquirer, the jury deliberated for just seven hours over two days.

Glaxo is disputing the verdict, and plans to appeal, Bloomberg said. The company must still defend 600 other Paxil birth defects lawsuits.

SSRI Antidepressants Linked to Early Birth

Tue, 06 Oct 2009 00:00:00 -0700

Women who take antidepressants known as selective serotonin reuptake inhibitors or SSRIs during pregnancy may be more likely to experience premature birth than other women, according to a new study. The study, which was published in the Archives of Pediatrics and Adolescent Medicine, also found that babies born to women taking SSRIs were more likely to be admitted to an intensive care unit.

Popular SSRIs include Prozac, Paxil, Zoloft, Celexa, and Lexapro. SSRIs affect seratonin levels in the brain, a chemical neurotransmitter. Seratonin is produced in the brain on an ongoing basis and in response to pleasure-giving experiences, in a normally healthy system.

For this study, researchers at the Bandim Health Project in Guinea-Bissau looked at health records of more than 56,000 women who received prenatal care from the University of Aarhus Hospital between 1989 and 2006. About 300 of them had received SSRIs during their pregnancy and nearly 5,000 of the study participants had a history of psychiatric problems but did not take any SSRIs while being treated for their pregnancy.

According to the study authors, women who took SSRIs delivered their babies five days earlier than other women in the study, and were twice as likely to give birth prematurely. Babies born to these women were also more likely to have a five-minute APGAR score of seven or below. A baby considered healthy generally has a score of seven or higher. They also faced a higher risk of being admitted to the intensive care unit, and some showed signs of withdrawal.

In addition to preterm birth, SSRIs are associated with other serious side effects. Paxil, for instance, has been shown to increase the risk of heart related birth defects. In fact, on two occasions in 2005 , the Food & Drug Administration (FDA) requested that the labeling of Paxil be changed to include warnings on three studies that found an increase risk of birth defects. 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). That same year, the FDA also classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

Babies born to mothers who have taken antidepressants, including SSRIs in the third trimester of pregnancy have suffered complications from withdrawal, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. In many of these cases, tube feeding, help with breathing and longer hospitalization was needed.

Ex-Glaxo Exec Testifies at Paxil Trial

Mon, 21 Sep 2009 00:00:00 -0700

A former GlaxoSmithKline executive has testified that officials with the drug maker said in 2001 that a birth defect in a fetus was probably linked to the mother's use of Paxil, reported Bloomberg.com. Glaxo is facing some 600 pending cases in which Glaxo is alleged to have known Paxil causes birth defects, yet hid those findings.

The former Glaxo official stated, under oath during a Philadelphia state court trial, that the birth defect was revealed in the unborn baby of a woman taking Paxil when pregnant, said Bloomberg.com. That particular adverse event took place in 2001. Officials with the drug giant apparently indicated in Glaxo’s files that, after reviewing an email received from the woman who aborted her fetus because of a heart defect, it was “almost certain” Paxil was associated with the defect, said Bloomberg.com, citing Jane Nieman. Nieman is a former drug safety executive with Glaxo, said Bloomberg.com.

According to Nieman’s testimony, “I don’t know who made that assessment, but it’s there,” quoted Bloomberg.com. The testimony was videotaped from her deposition and played for jurors in a case involving another family in which a three-year-old boy—Lyam Kilker—allegedly suffered birth defects due to his mother’s Paxil use, reported Bloomberg.com. According to Philly.com last week, the plaintiff’s attorney claimed Glaxo ignored information that the antidepressant caused birth defects. The boy has undergone some cardiac surgeries and is expected to have to undergo at least one more operation.

Glaxo maintains it is not responsible for the heart defect diagnosed in Lyam, denies that it buried adverse event findings to maintain profits, and claims it properly tested Paxil, noted Bloomberg.com. Lyam’s mother, Michelle David, disagrees and alleges that the drug is responsible for her son’s heart defects, described by Bloomberg.com as “life-threatening.”

According to the U.S. Food & Drug Administration (FDA), in late 2005 it sent an alert to physicians about early studies suggesting Paxil could be a contributor to heart defects in babies when taken by expectant mothers in the first trimester, said Bloomberg.com, previously. Glaxo received reports of 50 miscarriages or intrauterine deaths by 1997, with its own scientists describing the amount of cases as an “alarming finding,” words omitted in the final report provided to the FDA, despite that it was mandated to include such information, reported Philly.com, citing the plaintiff attorney. Also, Bonnie Rossello, an executive at Glaxo, wrote in a 1997 memo that should animal studies be conducted, the drug maker could “bury” any negative findings, added Philly.com.

Regarding the woman who aborted her fetus over heart defects, it seems Glaxo was aware of the woman’s experience with Paxil in 2001 following her email to the drug maker looking for information concerning trials conducted on Paxil regarding birth defects, said Nieman, wrote Bloomberg.com. The woman wrote that while she was thrilled with Paxil’s benefits, “If there is a chance that this might hurt or affect the baby I want to know up front and I will somehow stop taking it for the time being,” said Nieman, quoting the email, reported Bloomberg.com. “… Please contact me as soon as possible. Please don’t forget about me,” the email went on to say.

Nieman said she was unclear who at Glaxo made the notation on it database, saying,” Somebody from GSK filled that in… There’s a possibility someone made a mistake and checked the box wrong.”

Kilker’s lawyers claim Glaxo built an advertising plan that included urging physicians to increase prescriptions written for expectant mothers suffering from anxiety, said Bloomberg. The family alleges Glaxo also hid Paxil’s birth defect links from the medical community.

Ghostwriting Prevalent in Medical Journals, Study says

Mon, 21 Sep 2009 00:00:00 -0700

Nearly eight percent of all medical journal articles are the work of industry-paid ghostwriters, according to a study that recently appeared in the Journal of the American Medical Association. The paper was presented this month at the sixth annual International Congress on Peer Review Congress and Biomedical Publication in Vancouver, Canada,

As we’ve reported in the past, ghostwriting involves the act of a drug company producing a journal article aimed at either counteracting criticism of a drug or embellishing its benefits. Usually, a drug maker hires a professional writing company to draft the article, and recruits a physician to sign off as the author. Once the article has been published, drug sales reps often present copies of the piece to physicians as evidence that the drug covered in the article is safe and effective. Critics of the pharmaceutical industry claim ghostwriting is a common practice.

We have long been reporting on the frequent use of ghostwriting by drug makers. For instance, in August, we detailed the so-called CASPPER program uncovered by attorneys representing plaintiffs in Paxil lawsuits. According to an Associated Press report on the program, one memo instructed Glaxo salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing Paxil.

Also in August, we reported that Wyeth-paid ghostwriters had authored more than two dozen medical journal articles to promote hormone replacement therapy. According to a report in The New York Times, the articles were published under the bylines of doctors who did not contribute much to the actual piece.

For the JAMA ghostwriting study, the authors conducted a survey of 900 research articles, reviews, or editorials that appeared in six general medical journals in 2008: Annals of Internal Medicine, JAMA, The Lancet, Nature Medicine, New England Journal of Medicine, and PLoS Medicine. The article authors were asked to complete an online questionnaire about ghostwriting and honorary authorship. The researchers conducting the survey received replies from 630 authors.

They found that 7.8 percent of all medical journal articles were written by un-credited ghostwriters. So-called "Honorary Authors" were also listed in about 20.6 percent of medical journal articles the researchers reviewed. An Honorary Author is someone credited with an article, but who in reality contributed very little.

The publication with the highest prevalence of ghostwritten articles was the New England Journal of Medicine, with 11 percent. The journal Nature Medicine had the highest prevalence of Honorary Authors, with 39 percent, the survey found.

Glaxo Accused Of Ignoring Paxil Birth Defect Risks

Wed, 16 Sep 2009 00:00:00 -0700

Last week we wrote that drug maker GlaxoSmithKline Plc was scheduled to defend itself in a Philadelphia court this week over allegations its blockbuster antidepressant Paxil, (generic: paroxetine) can lead to birth defects when taken by pregnant woman. Bloomberg.com described the lawsuit as a “test case” for some 600 other similar cases.

According to Philly.com, at the start of that trial this week, a plaintiff's attorney claimed Glaxo ignored information that Paxil caused birth defects. The lawyer represents a mother who said her three-year-old son is suffering from cardiac issues because she took Paxil while pregnant. The attorney also told the jury that Glaxo advised its scientists to not reveal any potential risks Paxil presented to pregnant women, Philly.com said.

Patients and their parents claim that internal Glaxo documents show the drug maker neglected to publicize warnings about Paxil’s risks until it was compelled to do so by the U.S. Food and Drug Administration (FDA) in 2005, said Bloomberg.com, last week. Paxil was approved by the agency in 1992.

Although Glaxo argued that its drug did not cause the boy’s heart problems, the woman’s lawyer noted that in initial testing, when rats received Paxil, their pups did not live more than four days. Plaintiff attorneys claim Glaxo’s paperwork prove it was aware Paxil could increase birth defect risks as far back as 1980 and that it did not fully research Paxil before—and after—release to market, said Bloomberg.com, previously.

The attorney pointed out that going back to the late 1980s, a Glaxo scientist stated that, "there remains the possibility that Paxil could cause birth defects at higher doses," reported Philly.com. According to the attorney, for two decades, Glaxo allegedly neglected to understand what caused the rat pups, whose mothers took Paxil when pregnant, to die, said Philly.com. “There remains the possibility that this compound could be teratogenic at higher dose levels. A teratogenic agent is one that causes malformations of an embryo or fetus,” wrote company scientist John Baldwin in a 1980 memorandum, quoted Bloomberg.com.

According to the FDA, in late 2005 it sent an alert to physicians about early studies suggesting Paxil could be a contributor to heart defects in babies when taken by expectant mothers in the first trimester, said Bloomberg.com, previously. The government asked Glaxo to update medication information warning on birth defects.

An attorney for Glaxo argued that while the boy was hospitalized for months following his birth and underwent cardiac surgeries that today, he "has no cardiac symptoms … is at preschool and runs and walks like a 4-year-old should," quoted Philly.com. The boy’s attorney argued that the boy will need more cardiac surgery.

Glaxo received reports of 50 miscarriages or intrauterine deaths by 1997, with its own scientists describing the amount of cases as an "alarming finding," words omitted in the final report provided to the FDA, despite that it was mandated to include such information, reported Philly.com, citing the plaintiff attorney.

Worse, Bonnie Rossello, an executive at Glaxo, wrote in a 1997 memo that should animal studies be conducted, the drug maker could “bury” any negative findings, added Philly.com.

Paxil Lawyers Uncover Glaxo Ghostwriting Program

Fri, 21 Aug 2009 00:00:00 -0700

Paxil medical journal articles written by GlaxoSmithKline consultants were prepared using a sophisticated ghostwriting program that allowed doctors to take credit for the work. According to the Associated Press, the ironic name for the ghostwriting program was CASPPER.

As we've reported in the past, ghostwriting involves the act of a drug company producing a journal article aimed at either counteracting criticism of a drug or embellishing its benefits. Usually, a drug maker hires a professional writing company to draft the article, and recruits a physician to sign off as the author. Once the article has been published, drug sales reps often present copies of the piece to physicians as evidence that the drug covered in the article is safe and effective. Critics of the pharmaceutical industry claim ghostwriting is a common practice.

Documents detailing the CASPPER program were uncovered by attorneys representing plaintiffs in Paxil lawsuits, according to the Associated Press. Lawsuits allege that Glaxo downplayed Paxil's association with serious side effects, such as suicide and birth defects.

The documents reviewed by the Associated Press include a company memo from April 2000 which stated the CASPPER program was designed to "strengthen the product positioning and overcome competitive issues." The memo instructs Glaxo salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing Paxil, the Associated Press said. According to the memo, CASPPER could help physicians with everything from "developing a topic," to "submitting the manuscript for publication."

We have long been reporting on the frequent use of ghostwriting by drug makers. For instance, earlier this month we reported that Wyeth-paid ghostwriters authored more than two dozen medical journal articles to promote hormone replacement therapy. According to a report in The New York Times, the articles were published under the bylines of doctors who did not contribute much to the actual piece.

Earlier this summer, we reported that Zyprexa maker Eli Lilly apparently asked doctors to put their names on articles written by company officials in an effort to promote the drug. The company’s alleged strategy to use ghostwritten articles to increase Zyprexa sales was revealed when more than 10,000 pages of internal documents that were unsealed in May in lawsuits alleging Eli Lilly exaggerated Zyprexa’s effectiveness.

Last April, the Journal of the American Medical Association published analysis of court documents uncovered in the course of Vioxx injury lawsuits that found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies.

Settlement Proposed in Paxil Class Action Lawsuit

Fri, 27 Mar 2009 00:00:00 -0700

A settlement has been proposed in the so-called Paxil "split pill" class action lawsuit. According to a press release, if approved, the settlement will provide up to $28 million to claimants and their insurance companies.

Paxil is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Paxil was approved to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Paxil was the first antidepressant formally approved in the US for the treatment of social anxiety disorder.

The drug has been linked to a variety of problems, including birth defects, as well as suicide and suicidal tendencies when taken by young people and children. Yet in spite of these risks, by 2006 Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.

The Paxil "spit pill" class action lawsuit alleges that Paxil "controlled release" (CR) tablets made between April 1, 2002 and March 4, 2005, contained a manufacturing defect that caused them to split apart. According to the complaint, Paxil CR tablets are intended to deliver the active ingredient over a period of time, and not all at once. When one splits apart, the outside coat breaks up and the drug is released while the tablets are still in the stomach. Patients end up with all of the active ingredient, without the benefits of the controlled-release, and received the entire dose at once. Or they get only the controlled-release ingredient without the active ingredients, the complaint says.

In March 2005, armed marshals with the Food and Drug Administration (FDA) raided GlaxoSmithKline plants in Puerto Rico and Tennessee after learning that some pills manufactured there had split apart. The FDA had originally discovered the problem at the Puerto Rico plant in February 2002, and the problem continued despite repeated warnings and inspections, the complaint charges.

If approved, the $28 million settlement will be split between consumers who paid for their Paxil and insurance companies seeking to be reimbursed for their expenditures. The amount each class member recovers will depend on how many defective pills they bought, with a maximum recovery of $150 per person. A final approval hearing will be held on July 10, 2009.

Under the settlement, GlaxoSmithKline denies liability and all of the claims in the lawsuit.

Antidepressants Linked to Sudden Cardiac Death in Women

Wed, 11 Mar 2009 00:00:00 -0700

A new study has concluded that women with no history of cardiac problems but who use antidepressants are at an increased risk for sudden cardiac death (SCD). HealthDay News reports that the reason for the link remains unknown, according to the researchers whose findings were published in the Journal of the American College of Cardiology.

"We suspect that their use is a marker for people with worse depression," explained the study’s lead author Dr. William Whang, an assistant professor of clinical medicine at Columbia University Medical Center in Manhattan. "The elevated risk seems more specific for antidepressant use, but that use may well be a marker of more severe symptoms," quoted HealthDay News. Whang noted that the link seemed to be physiological saying, “We found that women who had worse depressive symptoms had higher rates of risk factors such as hypertension, diabetes, and smoking.” As a matter-of-fact, the report indicated, said HealthDay News, women with clinical depression were at a two-fold risk of experiencing SCD.

The researchers looked at over 63,000 American women in the Nurses Health Study, said HealthDay, with no history of previous stroke or heart disease from 1992 to 2004, said Natural News, and found a link between depression and heart risk; however, the link between SCD and antidepressants was significantly more pronounced. Also, antidepressant use was not linked with an increased risk of cardiac arrest over fatal heart disease, only with the increased risk of SCD, reported HealthDay News. Prior research established the link between depression and an increased risk of death for those with heart disease, explained Whang, who noted, "But this was a group of women without heart disease, and that makes it different," said HealthDay News.

Natural News pointed out that the study found women with the highest risk for SCD and fatal coronary heart disease (CHD) expressed the most severe depression symptoms or were on antidepressant therapy. "We can't say antidepressant medications were the cause of higher risk of sudden cardiac death. It may well be that use of antidepressants is a marker for worse depression," said Whang, reported Natural News. "The biggest clinical implication is that management of coronary heart disease risk factors may be especially important for those with depressive symptoms. Taking care of those risk factors can modify the risk for coronary disease," warned Whang, according to HealthDay News.

To determine which women suffered from depression, the team reviewed their self-reported depression symptoms and use of antidepressants, for instance, Prozac, said Natural News. A link was clearly present with serious heart rhythm problems, which include those causing sudden death, said HealthDay News. The American Heart Association explained, said Natural News, that SCD causes sudden death from an unexpected loss of heart function.

SSRI antidepressants, such as Prozac, Lexapro, Zoloft, and Paxil have been described as safe for the heart; however, a number of cardiovascular side effects, such as irregular heart rhythms and potentially lethal arrhythmias, are known to occur in some taking these medications, said Natural News, noting that Prozac maker, Eli Lily, lists a variety of adverse cardiac symptoms on the official package insert for physicians.

Emory Researcher Sanctioned for Failing to Disclose Drug Company Payments

Tue, 23 Dec 2008 00:00:00 -0800

A prominent Emory University professor has lost a chairmanship as a result of a controversy stemming from payments he received from drug companies. The Wall Street Journal reported today that Charles Nemeroff is stepping down from his position as head of the school's Department of Psychiatry and Behavioral Sciences, position he has held since 1991, following an internal investigation. The university will also be restricting Nemeroff's research and extracurricular activities.

Nemeroff has been cited several times in an investigation being conducted by Sen. Charles Grassley (R-Iowa), who has been probing the financial ties between medical researchers and the pharmaceutical industry. As Grassley's investigation focused more and more on Nemeroff's possible conflicts-of-interest, Emory promised an investigation.

According to The Wall street Journal, that investigation found that Nemeroff failed to report to Emory more than $800,000 he received from Glaxo for more than 250 speaking engagements from Jan. 2000 to Jan. 2006. According to the Atlanta Constitution-Journal, Emory's investigation also found that Nemeroff received income from other drug makers, but Glaxo was by far his biggest patron.

In October, we reported that documents released by Emory to Grassley’s investigators indicated that Nemeroff was paid more than $2 million by pharmaceutical companies, but failed to report more than $1 million of that income to the school while working on government-funded drug researcher. Those documents include a letter from Nemeroff dated July 15, 2004 in which he promises Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules. But in that same year, Nemeroff actually earned $170,000 from Glaxo for giving talks about Paxil and other drugs the company made.

According to a report in The Wall Street Journal last week, Emory has tried to explain the Glaxo payments by claiming they were for talks that weren’t promotional in nature but instead were “CME-like” (a term for continuing medical education). Emory claims that the distinction led Nemeroff to believe he didn’t need to disclose those payments, the Journal said.

But in a letter dated Dec. 17, Grassley voiced skepticism. “Neither anyone on my staff, nor any medical expert that they have contacted, have ever heard of the term ‘CME-like,’” he wrote. “It appears to be a new term created at Emory University.”

Grassley also criticized Nemeroff for a letter he wrote in 2000 when he was also serving as editor in chief of the journal Depression and Anxiety. According to the Journal, which termed the missive a “Dear Me” letter, Nemeroff wrote it on the journal’s letterhead, and indicated he being paid $3,000 by the publication to write an article about Wyeth Pharmaceutical’s antidepressant, Effexor. But Nemeroff also billed Emory that exact amount for the article. It’s not clear if Nemeroff received two payments of $3,000, one from Emory and one from the journal.

According to The Wall Street Journal, 14 other Emory faculty members received similar payments to write Effexor articles for the same issue of Depression and Anxiety. Grassley says their payments, and the $3,000 Nemeroff received from Emory actually came from a grant furnished by Wyeth. According to the senator, the issue of Depression and Anxiety where the articles appeared fails to mention that any of the authors, including Nemeroff, received payments from a Wyeth grant.

In addition to reaching an agreement with Nemeroff to leave the department chairman post, The Wall Street Journal reported that Emory will not submit any National Institutes of Health grant or contract requests in which Nemeroff is listed as an investigator for two years. Nemeroff will also need pre-approval from the dean of the medical school for any outside income, the Journal-Constitution said.

Paxil, Prozac Linked to Heart Birth Defects

Tue, 25 Nov 2008 00:00:00 -0800

Paxil and Prozac, two popular antidepressants, have been linked to heart birth defects by a new study. According to an article published in the November issue of The British Journal of Clinical Pharmacology, the risk for such birth defects was the highest among Prozac users who also smoked during their pregnancy.

For the study, researchers from Israel, Italy and Germany looked at the pregnancy outcomes of 2,191 women. Of those, 410 had taken Paxil during their pregnancy, while 314 had taken Prozac. The remaining 1,467 had no exposure to either antidepressant.

Among the group taking Prozac, the prevalence of major heart birth defects was 2.8%. It was 2% in the Paxil group and 0.6% in the control group. That means that women who took Prozac during pregnancy were 4.47 times more likely to have a baby with a heart anomaly and women who took Paxil were 2.66 times more likely. There was no increase in other major congenital anomalies, although the study did find that women taking Prozac or Paxil had babies with slightly lower birth rates than those in the control group.

The study also found that women who smoked more than 10 cigarettes a day while taking one of the antidepressants were 5.40 times more likely to have a baby with a heart anomaly. Those smoking less than ten cigarettes a day were 2.75 times more likely to have a baby with a heart birth defect, the study said.

According to the researchers, the risk of heart birth defects was highest among those smokers who took Prozac. “These findings clearly show a significant association between major heart anomalies and taking fluoxetine (Prozac) and smoking during pregnancy,” lead author Professor Asher Ornoy from the Israeli Teratology Information Service in Jerusalem, Israel, told Science Daily.

According to Science Daily, the researchers are urging pregnant women who must use one of the antidepressants to stop smoking if they do so. They also recommended that those taking Prozac be given a fetal echocardiogram in their second trimester to diagnose possible heart anomalies.

Pregnant women taking either drug should speak to their doctors, but they should not stop their medication unless they are told to do so, Science Daily said.

Emory Psychiatrist Didn't Disclose Drug Company Payments

Mon, 06 Oct 2008 00:00:00 -0700

An Emory University psychiatrist who was paid more than $2 million by pharmaceutical companies failed to report a substantial portion of that income while working on government-funded drug researcher. According to documents the university furnished to congressional investigators, Dr. Charles B. Nemeroff did not disclose $1.2 million of that income to the school, in violation of federal research rules. Nemeroff if one of the nation's top psychiatric researchers, and according to The New York Times, is the most prominent person named in Grassley's probe thus far.

Among the documents obtained by congressional investigators is a letter signed by Nemeroff dated July 15, 2004 in which he promises Emory administrators that he would earn less than $10,000 a year from GlaxoSmithKline to comply with federal rules. But in that same year, Nemeroff actually earned $170,000 from Glaxo for giving talks about Paxil and other drugs the company made.

Nemeroff's failure to fully disclose his financial relationship with the drug industry is just the latest revelation in a probe led by Senator Charles Grassley (R-Iowa). Universities are supposed to monitor conflicts when their researchers receive government grants. According to The New York Times, Grassley has been asking some of the nation’s leading researchers to provide their conflict-of-interest disclosures, and is comparing those documents with records of actual payments from drug companies.

Grassley is a sponsor of the Physician Payment Sunshine Act, which would require drug and device companies to publicly list payments to doctors that exceed $500. The Senator has already discovered many instances where researchers' disclosures did not match the drug companies' records. Harvard, Brown and Standford universities are just a few of the institutions where discrepancies have been found.

In a letter to Emory President James W. Wagner dated last Thursday, Grassley said that from 2000 through 2006, Nemeroff received just over $960,000 from Glaxo, but reported to the university that he received no more than $35,000. From 2003 until this past summer, Nemeroff was the primary investigator on a federally-funded research project conducted jointly by Emory, Glaxo and the National Institute of Mental health that examined five Glaxo drugs considered for use as possible antidepressants.

According to federal research rules, universities are supposed to inform the National Institutes of Health (NIH) when a researcher receives annual income from a drug company totaling more than $10,000. According to documents obtained by congressional investigators, Nemeroff would have exceeded the NIH's $10,000 limit in 2003, 2004, 2005 and 2006. Emory should have either taken steps to deal with the conflict or to remove Nemeroff as the investigator.

But Emory took Nemeroff's word that his drug company income did not exceed NIH limits. This despite the fact that Emory’s conflict of interest committee investigated Nemeroff in 2004, and submitted a report to the university that detailed multiple “serious” and “significant” violations of university procedures intended to protect patients. At the time, he had consulting arrangements with about a dozen companies, including Merck & Co., Bristol-Myers Squibb Co. and Eli Lilly & Co. Even then, Emory took no action against Nemeroff, nor did it subject his financial ties with drug companies to further scrutiny.

This is not the first time that Nemeroff's ties to the pharmaceutical industry have raised questions. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after failing to disclose financial ties to Cyberonic's Inc., the maker of a depression-treating device that received a favorable review in a paper he co-authored. At the time, Nemeroff blamed the omission on a "clerical error".

On Friday night, the day after Grassley's letter to the university's president was made public, Emory announced that Nemeroff would “voluntarily step down as chairman of the department, effective immediately, pending resolution of these issues.”

Glaxo Settles One Paxil Lawsuit, Faces Two Others

Thu, 02 Oct 2008 00:00:00 -0700

Paxil maker GlaxoSmithKline has agreed to pay $40 million to settle a class action lawsuit involving the drug. The settlement will reimburse health plans that paid for children and adolescents to receive Paxil. Meanwhile, Glaxo was just named a defendant in another Paxil lawsuit filed by two West Virginia families who claim the drug was responsible for birth defects suffered by their children.

Paxil is not approved for use in children, but doctors are free to prescribe medications in anyway they see fit. Several studies have linked Paxil and similar antidepressants to suicide in teenagers. Last year, the Food & Drug Administration (FDA) ordered Glaxo and the makers similar drugs to include a black box warning – the agency’s strongest safety notice - about their risks to children on the drugs’ labels

Critics of Glaxo have charged that the company knew about Paxil’s problems with suicidal behavior long before it ever made them public. Recently, British authorities concluded a four-year investigation into whether Glaxo failed to inform drug regulators in that country about a link between Paxil and suicidal behavior in children and teens in a timely matter. Criminal charges were not pursued in that case because British laws are unclear on whether companies are obligated to report certain drug data. Glaxo’s handling of Paxil suicide data is also the subject of a congressional probe in the U.S.

The just-settled class action lawsuit alleged Glaxo withheld negative information about the safety and efficacy of Paxil for teenagers and children. The Paxil settlement announced yesterday involves 42,000 health plans that paid for a Paxil prescription for use by a minor between January 1998 and December 2004. The insurers can recover 40 percent of their actual costs of the drugs prescribed to children and adolescents diagnosed with a major depression, or 15 percent of the cost if the diagnosis was unknown.

This is the second Paxil class action lawsuit that Glaxo has settled recently. In 2007, Glaxo agreed to pay $63.9 million to settle a lawsuit filed by consumers. The company did not admit wrongdoing in either lawsuit.

But even as it settled this lawsuit, Glaxo faced two others in West Virginia involving birth defects allegedly caused by Paxil. Both suits were filed by families who claim that the heart birth defects suffered by their children were the result of their mothers’ Paxil use during pregnancy. The lawsuits claim the women took the drug believing it to have no adverse side effects because company promotions touted the drug as a safe alternative for pregnant women. When they were born, both children suffered from congenital injuries and disorders and birth defects, as well as heart defects and developmental delays, the suits state.

The lawsuits claims that Glaxo knew that Paxil was associated with birth defects, but did not inform doctors of the risks until 2005 when it revised Paxil's label indicating the dangers. The lawsuits are seeking unspecified compensatory damages, pre- and post-judgment interest, court costs, a refund of all costs associated with the purchase of Paxil and disgorgement of the company's profits from Paxil.

In December 2005, the FDA announced that it was requiring Glaxo to add additional warnings about Paxil birth defects to the drug's prescribing information after 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. The FDA also moved Paxil from pregnancy Category C (Risk of Fetal Harm Cannot be Ruled Out) to Category D (Positive Evidence of Fetal Risk).

American Children Take the Most Psychotropic Drugs

Fri, 26 Sep 2008 00:00:00 -0700

A new study reports that American children are about three times likelier to be prescribed psychotropic medications than children in Europe. The study states that the differences may be attributable to regulatory practices and cultural beliefs about the role of medication in emotional and behavioral problems.

Julie Zito led the team comprised of researchers from the U.S., Germany, and the Netherlands. The group investigated prescription levels in the three countries. Zito reported that, "Antidepressant and stimulant prevalence were three or more times greater in the U.S. than in the Netherlands and Germany, while antipsychotic prevalence was 1.5 to 2.2 times greater." The use of antidepressants, such as Prozac, and stimulants, such as Ritalin, in children has been the subject of much controversy; this study is believed to quantify the differences in practice between the US and Western Europe.

Study authors believe the differences may be partly due to different diagnostic classification systems. For instance, "The US trend of increasing bipolar diagnosis in children and adolescents does not reflect European practice." The team also discussed government cost restrictions in Europe, the increased amount of child psychiatrists per capita in the U.S., as well as the U.S. practice of using two or more different psychotropic drugs in a single year as possible explanations. "Direct to consumer drug advertising, which is common in the U.S., is also likely to account for some of the differences. The increased use of medication in the US also reflects the individualist and activist therapeutic mentality of US medical culture," Zito added.

Earlier this month we reported about one million children and teenagers are treated for schizophrenia and prescription rates for atypicals—the anti-psychotic drugs most prescribed for these disorders—have increased more than five-fold for children over the past 15 years and are also being used to control outbursts and aggression in children with a wide variety of diagnoses representing about 80 percent of the prescriptions written for maladies such as autism, ADHD, bipolar disorder, depression, and anxiety, despite the drugs’ serious side effects. Some uses are off-label, or not approved by the Food and Drug Administration (FDA). Approximately three million Americans suffer from schizophrenia and about 20 percent begin to show symptoms as children or teens.

Meanwhile, state officials are finding atypical antipsychotics have become the largest drug class in Medicaid and many question if this is due to marketing or need; several states are suing drug makers for off-label promotion and commissioning "ghost-written" articles to increase use. But, drug makers continue to obtain new approvals from the FDA to treat more conditions. In the last two years, Risperdal received approval to treat schizophrenia in adolescents and the irritability of autism in children ages five to 16. Nicola Huff, whose son, John Aaron, took Risperdal for seven years to resolve behavioral problems said at age 14, he developed female-sized breasts that had to be surgically removed. Tammy Wandling, whose son Austin has autism, said a psychiatrist put him on Risperdal at age four. In less than nine months, Austin developed a baseball-size growth in his right breast. Research suggests Risperdal can cause an increase in the hormone prolactin, which causes breasts to enlarge and produce milk.

Paxil Linked to Male Fertility Problems

Thu, 25 Sep 2008 00:00:00 -0700

A study of Paxil has found that the it - and possibly similar antidepressant - could damage fertility in some men. According to the study, conducted by scientists at Cornell Medical Center in New York, men who took Paxil for four weeks sustained damage to the DNA in their sperm.

Paxil - known generically as paroxetine - was brought to market by GlaxoSmithKline in 1992, and by 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions. Paxil is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Paxil has already been linked to an increased risk of birth defects, as well as suicidal behavior in children and teenagers. Studies have also shown that women taking SSRIs are more likely to have a low birth weight baby.

This latest Paxil study, which was published in New Scientist magazine, involved 35 men who provided sperm samples before and during Paxil treatment. When their sperm was examined under a microscope, the before and after samples did not appear much different.

However, tests on "DNA fragmentation" did show problems. Prior to Paxil treatment 13.8 percent of sperm cells were found to be fragmented. After taking Paxil for four weeks, that number had risen to 30.3 percent.

Studies of couples undergoing IVF have found that when a man's sperm has higher levels of DNA damage, fewer embryos are produced. Those embryos that are produced are less likely to implant successfully in the womb.

``We suspect the other SSRIs would have similar effects,'' Peter Schlegel, chairman of the urology department at the university's Weill Cornell Medical College in New York, told Bloomberg.com.

The same Cornell researchers who worked on this Paxil study had voiced similar concerns in 2006, after finding that two men had developed low counts of healthy sperm following treatment with two different SSRIs. SSRIs like Paxil and Prozac are the most commonly prescribed class of antidepressant.

The results of the Cornell Paxil study will be presented in November, at an American Society for Reproductive Medicine meeting in San Francisco.

Investigations Continue into Psychiatrists-Big Pharm Ties

Fri, 25 Jul 2008 00:00:00 -0700

Dr. Martin Keller, head of psychiatry at Brown University, is likely to be the next target in ongoing congressional investigations into the often too-friendly relationship between some doctors and pharmaceutical companies. Senator Charles E. Grassley—Republican-Iowa—the ranking member of the Senate Finance Committee is looking at consulting fees Keller received from drug companies for his research on the antidepressant Paxil. Meanwhile, Alison Bass, a former Globe reporter who wrote a book on Keller's research and the legal trial and fallout, said the move was a long time coming. Keller has never been publicly disciplined or sanctioned for his role in a study that hid the negative consequences of Paxil while promoting only positive outcomes. Despite this, "he is still chief of psychiatry [at Brown] and pulling in millions of dollars in research funding from the drug companies and federal research agencies," Bass said.

Studies have shown that researchers paid by a company are more likely to report positive findings when evaluating that company’s drugs. The private deals can directly affect patient care, said Dr. William Niederhut, a psychiatrist in private practice in Denver who receives no industry money.

Recently we reported that Grassley was demanding the American Psychiatric Association provide an accounting of its financing. “I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions,” Grassley said in a letter to the association. In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association’s $62.5 million in financing, with half that money going to drug advertisements in psychiatric journals and exhibits at the annual meeting; the remainder sponsored fellowships, conferences, and industry symposiums at the annual meeting.

Dr. Alan F. Schatzberg of Stanford and the association’s president-elect has $4.8 million stock holdings in a drug development company. Dr. Melissa P. Dobell of the University of Cincinnati reportedly worked for eight drug makers and told university officials that from 2005 to 2007 she earned about $100,000 in outside income. Meanwhile, AstraZeneca told Grassley it paid DelBello over $238,000 in that period, making some of those payments through MSZ Associates, an Ohio corporation DelBello established for “personal financial purposes.” In June, Grassley reported to Congress that Dr. Joseph Biederman, a renowned child psychiatrist at Harvard Medical School, and a colleague, Dr. Timothy E. Wilens, reported to university officials earning several hundred thousand dollars apiece in consulting fees from drug makers from 2000 to 2007. They actually earned at least $1.6 million each. Another Harvard group member, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Grassley’s investigators.

A Vermont study found that on average, psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs appear to have written three times as many prescriptions to children for the drugs as psychiatrists who received less or no funding. The drugs prescribed are not approved for most uses in children, who appear to be especially susceptible to the side effects.

A spokesman for Grassley's office said the senator is looking into 30 physicians from up to 20 universities, but wouldn't comment on any specific doctors.

Antidepressants Linked to Stomach Bleeding

Tue, 08 Jul 2008 00:00:00 -0700

A Spanish study in the Archives of General Psychiatry is reporting this week that antidepressants taken by millions of people may actually increase a patient’s risk of developing stomach ulcers. The drugs, which are known as selective serotonin reuptake inhibitors—or SSRIs—include Eli Lilly & Company’s Prozac, Forest Laboratories Inc.’s Celexa and Lexapro, GlaxoSmithKline Plc.’s Paxil, and Pfizer Inc.’s Zoloft.

According to Francisco de Abajo, from the Spanish Agency for Medicines and Healthcare Products, these drugs could trigger gastrointestinal bleeding in one out of every 2,000 patients. The study found that the risk also applies to Wyeth's innovative pill Effexor, but with Effexor, the risk increases to one in 250 patients when aspirin or pain drugs also are taken. The researchers found that these medicines interfere with platelets, “a critical part of the body's normal clotting process.” “The risk … should be considered, de Abajo said, adding that  "The risk … may be much more important in patients," with a history of ulcers or who regularly use medications such as aspirin and pain pills. The researchers studied the medical records of 1,321 patients with upper gastrointestinal tract bleeding, and compared them with a healthy group of 10,000 people. Of those with bleeding, 5.3 percent were taking SSRIs as compared with three percent of the healthy group. Of those who experienced bleeding, about 1.1 percent were taking Effexor, a different type of antidepressant, compared with 0.3 percent among those without an ulcer.

de Abajo suggests that proton pump inhibitors—drugs that suppress the production of acid in the stomach—such as Prevacid, Prilosec, Nexium, and Protonix, could help minimize the bleeding “for those most vulnerable and should be considered.” AstraZeneca, Plc., the maker of Nexium and Prilosec, helped fund the Spanish study.

Meanwhile, the Food & Drug Administration (FDA) has investigated a suspected link between cardiac trouble and acid-reflux drugs Prilosec and Nexium. Also, because both drugs are proton-pump inhibitors, they may be overly effective at stopping stomach acid production, raising pneumonia, bone loss risk, and fracture risk, this by over 40 percent in patients on long-term use.

In a study we reported on in February that was conducted by British researchers on the effect of some antidepressants found that they may only really be truly effective in the most severely depressed of patients. The study also found that these antidepressant medications actually work no better than placebos in many patients taking them and that the patients fared the same whether on a placebo or on one of the antidepressant medications represented in the study: Prozac, Effexor, and Paxil.

Meanwhile, there have been warnings that antidepressants might increase suicidal behavior in youth. U.S. and European regulators sent out a series of public health warnings in 2003 after clinical trials showed the drugs increased the risk of suicidal thoughts and behaviors in children and teens. In 2004, the FDA issued its strongest warning—a black box—on all antidepressant use in children and teens to draw attention to these medications’ possible risks.

Paxil Probe Said to Be Growing

Fri, 20 Jun 2008 00:00:00 -0700

An investigation into the antidepressant Paxil appears to be getting bigger. According to The Wall Street Journal, GlaxoSmithKline has confirmed that a previously disclosed Colorado-based Justice Department investigation of marketing practices now also includes the Boston U.S. attorney's office and is being coordinated by the agency in Washington.

Paxil - known generically as paroxetine - was brought to market by GlaxoSmithKline in 1992, and by 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.

In September 2004, the Food & Drug Administration (FDA) issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. The warning followed a report issued by Britain’s Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.

On May 12, 2006, the FDA issued another Paxil suicide warning when results of another study showed that Paxil increased suicide risk in young adults aged 18-30. An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the placebo. Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.

According to The Wall Street Journal, at a meeting in Boston last year, lawyers representing families suing Glaxo were asked about information, documents and depositions concerning Paxil's potential link to suicidal behavior in adolescents and adults, and how the company portrayed that risk to doctors and to the FDA.

According to some who attended the meeting, the Justice Department was particularly interested in documents disputing research conclusions that Glaxo submitted to the FDA on suicidality. Investigators asked many questions related to a controversial 2001 study paid for by Glaxo that has become known as Study 329. That study supposedly showed Paxil was safe for teens and children. Study 329 has come under fire from several independent medical researchers. The prosecutor and FBI "were quite interested in how Study 329 was used to promote Paxil for teenagers and kids by clinical researchers Glaxo had underwritten," a plaintiffs' lawyer who attended the meeting told The Wall Street Journal.

News of the expanded Paxil probe comes just months after British authorities concluded a four-year investigation into whether Glaxo failed to inform drug regulators in that country about a link between Paxil and suicidal behavior in children and teens in a timely matter. Criminal charges were not pursued in that case because British laws are unclear on whether companies are obligated to report certain drug data.

Last week, Sen. Charles Grassley (R-Iowa) has also asked the FDA to probe whether Glaxo knew of Paxil’s suicide risk when it first sought approval for the drug. In his letter to the agency, Grassley cited the British investigation.

Paxil Suicide Data Should be Investigated, Grassley Says

Fri, 13 Jun 2008 00:00:00 -0700

A U.S. lawmaker wants to know if the maker of Paxil withheld data regarding the popular antidepressant's association with suicide. Sen. Charles Grassley (R-Iowa) has asked the Food & Drug Administration (FDA) to probe whether GlaxoSmithKline new of Paxil's suicide risk when it first sought approval for the drug.

Paxil - known generically as paroxetine - was brought to market by GlaxoSmithKline in 1992, and by 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.

In September 2004, the FDA issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. The warning followed a report issued by Britain's Department of Health which said that evidence provided by the drug company from nine studies based on more than 1,000 youngsters shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.

On May 12, 2006, the FDA issued another Paxil suicide warning when results of another study showed that Paxil increased suicide risk in young adults aged 18-30. An analysis of multiple trials including 15,000 patients revealed 11 attempted suicides among Paxil users and only 1 attempted suicide among those taking the placebo. Of the 11 suicide attempts in Paxil users, 8 were in people aged 18 to 30.

But there is evidence that GlaxoSmithKline knew about the Paxil suicide risk long before the 2004 warning was issued. In his letter to the FDA, Grassley cites a report by British regulators that found that Glaxo knew as far back as 1998 that Paxil was associated with a higher risk of suicidal behavior in adolescents.

Grassley also asked the FDA to review a report by a Harvard psychiatrist who had submitted information as part of several lawsuits. The report, written by Joseph Glenmullen, found that Glaxo "had to know of Paxil's suicide risk when it sought FDA approval for the drug," Grassley's letter said. Glenmullen found that Glaxo inappropriately inflated the suicide risk of a placebo during clinical trials of the antidepressant, obscuring the increased danger associated with Paxil.

In addition to the suicide risk, Paxil has also been linked to an increased risk of birth defects, especially those involving the heart. In 2005, the labeling of Paxil was changed twice to reflect information from several studies that found this risk.

Paxil and ASD / VSD (Heart Birth Defects)

Fri, 16 May 2008 00:00:00 -0700

Paxil Heart Birth Defects (ASD / VSD)

Keywords: Paxil ASD Lawyer VSD Heart Lawsuit Birth Defects

The lawyers and attorneys at our firm are currently offering free case evaluations to families whose children were born with heart defects, specifically Atrial Septal Defects (ASD) and Ventricular Septal Defects (VSD), due to their mother's use of Paxil while pregnant. While several studies have linked the antidepressant Paxil to a number of birth defects, by far the most common problems associated with Paxil use during pregnancy are ASD and VSD. These heart defects, which involve holes between the heart's pumping chambers, can be devastating, and often babies with these problems must undergo painful surgeries to correct them. Our Paxil heart defect lawyers will make sure that infants and families coping with ASD or VSD are compensated for these injuries.

Ventricular Septal Defects

A ventricular septal defect (VSD) is a hole between the right and left pumping chambers of the heart. VSD is among the most common congenital heart defects, occurring in 0.1 to 0.4 percent of all live births and making up about 20 to 30 percent of congenital heart lesions. VSD is probably one of the most common reasons for referral of an infant to a cardiologist.

Although babies with large VSDs may do very well in the first weeks of life, such defects eventually become dangerous. In these cases, VSD will gradually lead to symptoms of congestive heart failure and must be treated. Medium or moderate VSD is more challenging to predict. Sometimes babies born with moderate VSD will have problems with congestive heart failure like babies with large VSD. Others will have no problems at all and just need to be watched.

VSD has can have a very characteristic heart murmur, however, a murmur is often not heard at birth, especially in a large VSD. It is only when there is excessive flow across the hole into the lungs that a murmur can be appreciated. Babies who do have moderate or large VSD with excessive blood flow to the lungs will have signs of congestive heart failure. The most important sign will be the baby's growth. In older children, lower energy levels compared to other children the same age may be a symptom of VSD.

Babies who have shown some signs of congestive heart failure from VSD will typically be placed on medication, usually a diuretic to help get rid of extra fluid in the lungs. A medication like digoxin might be used to stabilize heart rhythm. In babies who are failing to thrive because it is too difficult for them to eat, a high calorie formula or fortified breast milk will be added to help the baby grow. A nasogastric feeding tube may be necessary to deliver the food if a baby is too weak. The point of such treatments is to control the symptoms of heart failure, and help the baby achieve normal growth.

Hopefully, the VSD will close and no other treatment will be needed. When the symptoms of VSD are hard to control with medicines or there is persistent evidence that the heart is doing extra work, surgical closure of the defect is often recommended.

In September 2005, the Food & Drug Administration (FDA) and GlaxoSmithKline, the maker of Paxil, alerted doctors about a new study on major birth defects seen in babies born to women who took the antidepressant during the first trimester of pregnancy. In the study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants. Most of these defects were heart related, and the most common heart problem seen in the study was VSD. At that time, the label of Paxil was modified to include information on this study.

The Paxil birth defect lawyers at our firm know that VSD can take an enormous toll on babies and their families. The medications and treatments used to stave off heart failure are expensive, and often carry other dangerous side effects. Surgery is always a painful and traumatic experience for infants. Our Paxil birth defect lawyers will do everything they can to make sure families victimized by this drug get their lives back on track.

Atrial Septal Defects

An atrial septal defect (ASD) is a hole in the wall between the two upper chambers of the heart. In some cases, the hole may close on its own, but often infants with ASD must undergo surgery to correct the problem. While ASD is sometimes diagnosed at birth, it is not unusual for the defect to be discovered later in life. An adult who has had an undetected atrial septal defect for decades may have a shortened life span from heart failure or high blood pressure in the lungs.

In December 2005, the FDA again announced that it was requiring GlaxoSmithKline to add additional warnings about Paxil birth defects to the drug's prescribing information. The FDA took the action because the early results of two more 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. In addition to VSD, the studies indicated that Paxil use during the early months of pregnancy put infants at risk of ASD. In addition to the label change, the FDA also moved Paxil to another pregnancy category. The FDA had previously classified the Paxil birth defect risk as Category C (Risk of Fetal Harm Cannot be Ruled Out). The new Paxil labeling now classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

Infants with large atrial septal defects may have a poor appetite, and they often do not grow at a normal rate. In some cases, they may also exhibit signs of heart failure or arrhythmias. But very often, symptoms do not appear for years - when a person is in their 20s, 30s, or 40s - after ASD has done significant damage to the heart and lungs. Paxil was first approved in 1992, and thousands of pregnant women have taken the drug since then. Because the symptoms of ASD often take time to appear, our Paxil heart defect lawyers expect many cases of Paxil-related ASD will be diagnosed in adults in the coming years.

The symptoms of long-standing ASD include shortness of breath, fatigue, swelling of legs, feet or abdomen, and heat palpitations. Large ASDs can cause a range of life-threatening problems if they are not treated. These include right-sided heart failure, a higher risk of heart attack and stroke, and heart rhythm abnormalities.

In a child, doctors may observe the atrial septal defect for a period of time to see if it closes on its own. If a hole hasn't closed early in childhood, it usually will never close on its own and requires surgery to correct. For adults and children, surgery involves plugging or patching the abnormal opening between the atria. Doctors can do this through two methods: open heart surgery or cardiac catheterization. For children, both procedures involve a great deal of trauma and pain. Our Paxil injury lawyers want to make sure that GlaxoSmithKline is held accountable for the pain and suffering inflicted on Paxil birth defect victims.

Legal Help for Victims of Paxil-related ASD or VSD

If you or someone you know used Paxil during pregnancy and gave birth to a child with ASD, VSD or other heart defects, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) to discuss your case with an experienced Paxil birth defect lawyer.

Paxil Birth Defect - Club Foot

Fri, 16 May 2008 00:00:00 -0700

Paxil and Club Foot

Keywords: Lawyer Paxil Club Foot Lawsuit Birth Defect

The lawyers and attorneys at our firm are currently offering free case evaluations to families with children who were born with Club Foot because their mothers took Paxil during pregnancy. Club Foot is a birth defect that, if not treated, will lead to significant discomfort and disability by the teenage years. Studies have indicated that babies are far more likely to develop Club Foot if they are exposed to Paxil in the womb. These babies face years of treatment, possibly involving surgery. Our Paxil birth defect lawyers are dedicated to making sure the families of these babies are compensated for the medical bills they incur, as well as the pain and suffering they endure.

If you were taking PAXIL during your pregnancy and your child has a Club Foot Birth Defect, then fill out the Free Case Review Form (located just to the right) or call 800-LAW-INFO. There is No Cost To You.

The causes of Club Foot are not completely known, although genetics is thought to play some role. Environmental factors could also cause the disorder. A recent study conducted by the Institute of Reproductive Toxicology at the University of Ulm, Germany, noted that some women who took selective serotonin reuptake inhibitor antidepressants (SSRIs), such as Paxil, during pregnancy had infants born with Club Foot. A July 2007 article in the New England Journal of Medicine also found that women who took Paxil during pregnancy were at a 5.8 percent increase of having a child born with this defect.

Club Foot and its Treatment

Club Foot occurs when a newborn infant's foot is turned to the side and it may even appear that the top of the foot is where the bottom should be. The involved foot, calf, and leg are smaller and shorter than the normal side. The bones, joints, muscles, and blood vessels of the limb are also abnormal. A Club Foot occurs in approximately one in every 1,000 births, with boys slightly outnumbering girls. One or both feet may be affected.

Club Foot is treated with both non-surgical and surgical therapies, and most doctors will try to avoid surgery if possible. One non-surgical therapy for treating Club Foot is called the Ponseti method. It involves stretching, casting and bracing the limb to correct the Club Foot. With this method, the doctor changes the cast every week for several weeks, always stretching the foot toward the correct position. Once the foot has been corrected, the infant must wear a brace at night for two years to maintain the correction. While very effective, this treatment can be uncomfortable for an infant. It also has a risk of complications. While the child is in a cast, parents must watch for changes in skin color or temperature that may indicate problems with circulation.

Sometimes, surgery may be needed to adjust the tendons, ligaments and joints in the foot/ankle of a child with Club Foot. Usually done at 9 to12 months of age, surgery corrects all of a baby's Club Foot deformities at the same time. After surgery, a cast holds the Club Foot still while it heals. It's still possible for the muscles in a child's foot to try to return to the Club Foot position, and special shoes or braces will likely be used for up to a year or more after surgery. Unfortunately, surgery is not a complete cure, and will likely result in a stiffer foot than non-surgical treatment, particularly as the years pass by.

No matter what treatment is used, however, a corrected Club Foot will still not be perfect. The Club Foot will likely stay 1 to 1 1/2 sizes smaller and somewhat less mobile than the normal foot. The calf muscles in a child's Club Foot leg will also stay smaller. The treatment for a Club Foot - especially if it involves surgery - can be painful and traumatic for both the child and parents. The Paxil birth defect lawyers at our firm believe that GlaxoSmithKline should be held liable for this pain and suffering when Club Foot is the result of Paxil.

Paxil and Birth Defects

Paxil is one of the most popular antidepressants on the market, and by 2006, more than 19 million prescriptions had been written for the GlaxoSmithKline drug. Paxil was approved to treat symptoms of depression, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, generalized anxiety disorder, social phobia/social anxiety disorder, and premenstrual dysphoric disorder. Paxil was the first antidepressant formally approved in the US for the treatment of social anxiety disorder.

Major depression in women is most common during the childbearing years, and about 10% of pregnant women have the condition, which is often treated with an SSRI like Paxil. Some studies suggest that babies born to mothers who took SSRIs while pregnant may have temporary withdrawal symptoms. And in 2005, preliminary data from two studies suggested that babies born to mothers who took Paxil in early pregnancy are 1½ to 2 times more likely to be born with a heart defect than babies in the general population. The Paxil birth defect lawyers at our firm believe that GlaxoSmithKline has engaged in a concerted effort to downplay Paxil's risks, an we intend to hold the drug maker accountable for this.

Legal Help for Victims of Paxil-Related Club Foot

Children born with Club Foot as a result of Paxil and their families have valuable legal rights. If you or someone you know have suffered because of this injury, please fill out our online form or call us at 1-800-LAW-INFO (1-800-529-4636) to discuss your case with an experienced Paxil birth defect lawyer.

Paxil, Prozac, Zoloft and Other SSRI Antidepressants Tied to Premature Birth

Tue, 06 May 2008 00:00:00 -0700

Paxil and similar antidepressants have been linked to an increased risk of premature birth, a new study says. Premature birth is just one of the many risks posed by the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Paxil has been shown to increase the likelihood of heart-related birth defects when taken by women early in pregnancy, and all SSRIs increase the risk that a newborn will experience withdrawal symptoms when taken in the last trimester of pregnancy.

In addition to Paxil, other SSRIs include Prozac, Lexapro, Celexa, and Zoloft. SSRIs affect seratonin levels in the brain, a chemical neurotransmitter. Seratonin is produced in the brain on an ongoing basis and in response to pleasure-giving experiences, in a normally healthy system.

The new SSRI study, presented at the annual meeting of the American Psychiatric Association, involved about 200 pregnant women. About half of them suffered from depression, and half of those women took SSRIs throughout pregnancy. About 23 percent of those who took SSRIs throughout pregnancy gave birth to preterm babies. Only 6 percent of women who did not have depression and didn't take SSRIs had preterm babies.

Premature birth is associated with many serious health problems, including learning disabilities, mental retardation, and cerebral palsy. However, depression itself has been linked with an increased risk of premature birth, and pregnant women who are experiencing depression should work with their doctors to determine if the risk of these drugs outweigh their benefits.

In addition to preterm birth, SSRIs are associated with other serious side effects. Paxil, for instance, has been shown to increase the risk of heart related birth defects. In fact, on two occasions in 2005 , the Food & Drug Administration (FDA) requested that the labeling of Paxil be changed to include warnings on three studies that found an increase risk of birth defects. 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 ranged in severity from those that were minor and resolved without treatment to those that caused serious symptoms and needed to be repaired surgically. That same year, the FDA also classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

Babies born to mothers who have taken antidepressants, including SSRIs such as Paxil, in the third trimester of pregnancy have suffered complications from withdrawal, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. In many of these cases, tube feeding, help with breathing and longer hospitalization was needed.

Paxil Linked to Heart-Related Birth Defects

Wed, 23 Apr 2008 00:00:00 -0700

Safety information for Paxil, one of the most popular antidepressants on the market, has been updated twice to warn that the drug has been associated with birth defects. The Food & Drug Administration (FDA) requested the labeling updates on two occasions in 2005, after studies linked Paxil to heart defects in infants whose mothers had taken the drug in the first trimester of pregnancy.

Paxil, first marketed by GlaxoSmithKline in 1992, was the first antidepressant formally approved in the US for the treatment of social anxiety disorder. It is also approved to treat symptoms of depression, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, generalized anxiety disorder, and premenstrual dysphoric disorder. By 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions.

In September 2005, GlaxoSmithKline published a study of major birth defects in infants born to women who took antidepressants - including Paxil - early in their pregnancy. In the study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants, according to the FDA. Most of the birth defects seen in the study were heart related, and the most common heart malformations were ventricular septal defects, which are holes between the heart's two main pumping chambers. At that time, the FDA asked GlaxoSmithKline to update the Paxil label's precautions section to include data from this study.

In December 2005, the FDA announced that it was again requiring GlaxoSmithKline to add additional warnings about Paxil birth defects to the drug's prescribing information. The action was prompted by the publication of two more studies showing 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.

The FDA advised 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. The agency also said health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In addition, the FDA also decided to place Paxil in a new pregnancy category. The FDA had previously classified the Paxil birth defect risk as Category C (Risk of Fetal Harm Cannot be Ruled Out). The new Paxil labeling now classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

In general, Paxil should not be taken during pregnancy. 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. However, women taking Paxil should not stop taking it without first talking with their physician as Paxil withdrawal symptoms can be severe.

Pregnant women are urged to avoid Paxil

Thu, 30 Nov 2006 00:00:00 -0800

Pregnant women and those who plan to become pregnant should avoid taking the antidepressant Paxil if possible because of the risk of birth defects, a group of obstetricians said Thursday.

The opinion issued by the obstetric practice committee of the American College of Obstetricians and Gynecologists comes nearly a year after the Food and Drug Administration and manufacturer GlaxoSmithKline reclassified the drug to reflect studies in pregnant women that showed the drug poses a risk to the fetus.

Two studies of pregnant women who were taking Paxil during their first trimester have shown that their babies have heart defects at a rate that is as much as twice the norm, the FDA said at the time.

The American College of Obstetricians and Gynecologists also said the decision whether to treat pregnant women with SSRIs, a class of antidepressants that includes Prozac, Zoloft and Lexapro as well as Paxil, should be considered on an individual basis.

Exposure to SSRIs late in pregnancy has been associated with short-term complications in newborns, the doctors said.

However, reproductive-age women have the highest prevalence of major depressive disorders. The benefit to the mother of treatment with any of the drugs may outweigh the risk to the fetus.

The opinion appears in the December issue of the journal Obstetrics & Gynecology.

Studies Assess Mix of Antidepressants, Pregnancy

Thu, 09 Feb 2006 00:00:00 -0800

Three studies published over the past week have sparked new concerns about the health risks of taking and not taking antidepressants during pregnancy. Two of the studies point to possible dangers to the fetus, and in response to the latest study, released Wednesday by the New England Journal of Medicine, the Food and Drug Administration announced it was considering tougher warnings on the drugs' use.

Separate research, published last week in the Journal of the American Medical Assn., shows that mothers who stop taking the drugs run a high chance of slipping back into debilitating depression.

Taken together, the studies represent an increasingly difficult conundrum for mothers and doctors.

"These data make me feel all the more cautious about using antidepressants in pregnancy," said Dr. Victoria Hendrick, a professor of psychiatry at UCLA. "But it's still something I'm going to do because I see very, very depressed women."

Prozac and other antidepressants known as Selective Serotonin Reuptake Inhibitors enhance the action of the brain chemical serotonin.

Since being introduced in the late 1980s, the drugs have become the standard treatment for depression.

The range of effects of manipulating serotonin levels is not well understood. For example, serotonin can cause blood vessels to constrict. It also serves as a growth factor, helping organize neural circuitry in a maturing brain.

The FDA has begun to strengthen warnings concerning the use of the drugs by pregnant women. In December, the agency ordered a new warning label for paroxetine, sold under the brand name Paxil, after two studies linked it to heart defects in newborns.

The agency's new concern involves a lung problem known as persistent pulmonary hypertension, which normally occurs in 1 in 1,000 births.

The researchers found six times that risk in infants born to women on antidepressants.

The team interviewed 377 mothers of babies born with the condition, and found that 14 had taken antidepressants in the second half of pregnancy. In a control group of 836 mothers with healthy children, six had taken the drugs, according to the study in the New England Journal of Medicine.

The lung ailment leads to inadequate oxygen levels in the blood. Most babies recover. In severe cases it can cause deafness, neurological problems or death.

"We find the association they have reported with this very serious condition to be very worrisome," said Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs.

Christina Chambers, an epidemiologist at UC San Diego who led the research, cautioned that "even with a sixfold increase, you're still talking about a fairly low risk."

On Tuesday, a study published in the Archives of Pediatric and Adolescent Medicine bolstered previous reports that babies born to mothers on antidepressants could suffer signs of withdrawal from the drugs in the first few days of life.

Nearly a third of 60 newborns exposed to the drugs as fetuses experienced symptoms that included tremors, gastrointestinal problems and sleep disturbance, according to the study.

Two of the infants in the study suffered seizures. In most cases, the symptoms peaked in two days and then began subsiding.

When the researchers reviewed 37 cases of women taking paroxetine, they found that the symptoms did not occur at low doses.

The risks and the unknowns make it tempting for women to give up antidepressants for nine months.

The odds are against them. Researchers, led by Dr. Lee S. Cohen of Harvard Medical School, tracked 201 women who were taking antidepressants around the time they became pregnant. Sixty-eight percent of those who discontinued the medications relapsed into depression, compared with 26% of those who kept taking the drugs.

There are few studies on how a mother's depression, left untreated, affects the health of her fetus.

"These depressed women might not be eating right," Hendrick said. "They might be losing weight. Women might be suicidal. They might be more prone to smoking and drinking."

The use of antidepressants by women who are pregnant is widespread, since depression during pregnancy is fairly common. Nonetheless, it's not clear how many infants have been exposed.

The FDA said Wednesday that more research needed to be done.

The long-term effects of fetal exposure to antidepressants are particularly hard to determine. Research could require following children for a decade or more.

"There are not a lot of studies that look at these children five or 10 years down the line," said Dr. James Mills, an epidemiologist at the National Institute of Child Health and Human Development.

In recent years, the FDA has been criticized for being slow to react to evidence that the drugs can increase suicidal thoughts in some children and teenagers.

In 2004, the agency forced drug makers to include a strong warning of such risks in the information for their products.

Study: Antidepressants pose risks for newborns

Thu, 09 Feb 2006 00:00:00 -0800

A UCSD study released today is fueling concerns about the effects of certain antidepressant drugs on pregnant women, saying that their use late in pregnancy can significantly increase the chance of deadly lung problems in newborns.

Normally, the lung disorder is rare, with one to two per 1,000 births. But when pregnant women took the drugs in question after the 20th week of pregnancy, the incidence rose to six to 12 per 1,000 births, a report by Dr. Christina Chambers and colleagues at UC San Diego found.

The antidepressants that increased that risk are in a class called SSRIs or selective serotonin reuptake inhibitors. They include citalopram, fluoxetine, paroxetine and sertraline sold under 19 brand names, including Celexa, Prozac, Paxil and Zoloft.

Babies born with the lung disorder, persistent pulmonary hypertension or PPH, often require mechanical assistance to breathe. Between 10 percent and 20 percent will die soon after birth, while others will have developmental delays, hearing loss and brain abnormalities.

Chambers said she didn't want pregnant women now taking the drugs to become scared.

“Ninety-nine women in 100 who take SSRIs late in pregnancy will not have a baby with PPH, so the risk is fairly low,” Chambers said. “But the risk is higher than if the women don't take the drugs, so I think it's important to get the information out there so health providers and women aren't navigating in the dark.”

In a Washington news conference yesterday, a U.S. Food and Drug Administration official called Chambers' findings significant and “worrisome,” especially because 10 percent to 15 percent of women of reproductive age have major depression and are the biggest users of antidepressant drugs.

Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, added that the report comes only a few weeks after a flurry of other large studies on other problems with antidepressants, particularly SSRIs.

Kweder said the FDA will issue a “public health advisory” in the next few days that may include a recommendation that manufacturers of antidepressant drugs conduct additional safety studies.

Women should not go off their antidepressants cold turkey, Kweder said.

“Don't panic,” she said, adding that women with concerns should talk to their doctors. A decision about whether to stop taking the drugs should take into account the severity of the depressive symptoms that prompted the prescription.

“Stopping these medicines on your own can sometimes create more problems than it solves,” Kweder said. “Often these medicines are associated with withdrawal symptoms, which can be problematic for many patients.”

Recent reports have linked SSRIs and other antidepressants with problems in newborns such as not eating properly, jitters and seizures. One study published last week in The Archives of Pediatrics & Adolescent Medicine said 30 percent of infants exposed to SSRIs in the womb develop sugar imbalance, sleep disturbances and difficulty eating that show up like the symptoms of drug withdrawal.

In December, the FDA warned that the use of one SSRI, paroxetine sold as Paxil, during the first trimester is associated with increased risk of birth abnormalities such as cardiac defects.

Another study published last week in the Journal of the American Medical Association dispelled a previously held belief that hormonal and other biochemical changes in pregnant women somehow protected them from clinical depression.

Dr. Lee S. Cohen, a psychiatrist at Massachusetts General Hospital and lead author of the report, wrote that 68 percent of women who discontinued antidepressant treatment after getting pregnant had a significant relapse into depression before giving birth.

Published reports suggest that the use of antidepressants by pregnant women results in some negative impact for as many as 30 percent of their newborns, although most of the time the problems are short-lived and reversible.

“Most studies have not suggested a smoking gun for long-term problems with the use of SSRIs,” said Dr. James Mills, a researcher with the National Institute of Child Health and Human Development. “But that's not true for PPH. In that group (of newborns) the story is very different” because PPH is so serious.

In Chambers' study, the higher incidence of PPH did not occur in women who took non-SSRI antidepressants. These include tricyclics such as amitriptyline sold as Elavil, bupropion sold as Wellbutrin, venlafaxine sold as Effexor and trazodone sold as Desyrel.

The higher risk also was not seen in women who stopped taking SSRIs by the 20th week of pregnancy, her study found.

Asked if she she would take an SSRI if she were pregnant and depressed, Chambers said that it would depend on how depressed she was, what other coping mechanisms were available and whether she were given options for alternative medications.

She stressed that more research is needed to look further into the future for children exposed in the womb to antidepressants.

Chambers urged the FDA and drug companies to develop “better information about this group of antidepressants, and as it is developed it needs to be disseminated.”

The UCSD study, done with colleagues in Boston, Toronto and Philadelphia, is published in today's New England Journal of Medicine. Participants were enrolled from more than 100 hospitals, including 17 in San Diego County.

As they read Chambers' study, San Diego area psychiatrists yesterday said they were rethinking the way they prescribe this class of medication to patients who may be thinking of having children.

But sometimes they have no choice, they said, in the case of a patient who is severely depressed and for whom other categories of antidepressants don't work.

“Sometimes there is no other way to help a woman who is in a severely restless and agitated state,” said Dr. Rodrigo Munoz, a psychiatrist and former president of the San Diego County Medical Society.

“No doubt giving the woman any medication during pregnancy is taking a risk.”

Mission Valley psychiatrist Dr. Catherine Moore said she takes into account how sick her patient is.

“Some women are so depressed, they're not eating well, and that may have an effect on a baby's low birth weight or cause developmental delays,” Moore said.

That absolutely needs to be taken into account, she said.

The FDA's Kweder said the Chambers study, added to the others, “absolutely highlights the critical need for more and better information about the safety and best uses of drugs during pregnancy.

“What you're seeing is that our society's increasing reliance on pharmaceuticals is finally extending to pregnant women, but there's a paucity of information designed to look at this in a systematic way,” Kweder said.

Many Newborns Affected By Mothers' Use of Anti-Depressants during Pregnancy

Tue, 07 Feb 2006 00:00:00 -0800

A study published in the journal Archives of Pediatrics and Adolescent Medicine reports that nearly a third of infants born to women taking anti-depressants suggesting that expectant mothers may want to consider limiting the use of these powerful drugs during pregnancy.

Thirty percent of the 60 newborns exposed to selective serotonin reuptake inhibitors (SSRIs) in the womb were found to have withdrawal symptoms. 13% of the infants' symptoms were classified as severe said the study by Dr. Rachel Levinson-Castiel of the Children's Medical Center of Israel, in Petah Tiqwa. (Reuters)

Newborns exhibited symptoms such as high-pitched crying, tremors, gastrointestinal problems and disturbed sleep occurred in infants in the first 48 hours after birth. As the anti-depressant dosage taken by the mother increased, these symptoms became more pronounced.

After examining the 37 infants exposed in the womb to paroxetine hydrochloride, sold as Paxil by GlaxoSmithKline, researchers found the risk was highest among newborns exposed to 27 mg per day or more. Below 20 mg per day the risk of symptoms disappeared.

According to the study, symptoms usually did not peak until after the first day of life. The long-term effects, however, are not known. Two of infants who were exposed to the drugs suffered short seizures.

Previous studies into the effects of SSRIs on newborns have found other symptoms such as bluish skin color from lack of oxygen, rapid breathing, feeding difficulties, low blood sugar, and jitteriness.

But as we reported last week, women who are clinically depressed and are prescribed anti-depressants cannot simply count on hormonal changes in pregnancy to relieve their symptoms. Some women, therefore, face a severe catch-22 regarding whether or not to continue taking their medication.

"Because maternal depression during pregnancy also entails a risk to the newborn, the risk-benefit ratio of continuing SSRI treatment should be assessed," Levinson-Castiel wrote in the journal Archives of Pediatrics and Adolescent Medicine. Unfortunately, "the long-term effects of in utero exposure to SSRIs have not been demonstrated clearly," not even for those whose symptoms were severe early on, she wrote. (Reuters)

Both studies recommended that if pregnant women must continue to medicate themselves, that they decrease their drug regimen to a one drug, at the very lowest effective dose.

Heart-Related Birth Defect Warning To Be Added to Paxil

Fri, 09 Dec 2005 00:00:00 -0800

The FDA and GlaxoSmithKline (GSK) have strengthened the warning about using the antidepressant, Paxil, during early pregnancy.

The enhanced warning is based on early results from two studies that show a higher rate of heart-related birth defects in babies born to women who took Paxil during early pregnancy than in babies of mothers in the general population or of those who took other antidepressants.

The first study prompted an updated warning by GSK in September 2004. The results of a second study have prompted a further update that includes moving Paxil to a category "D" medication (as opposed to a category "C") for use during pregnancy.

The change specifically deals with use of the drug during early pregnancy. Category "D" drugs are those that have shown risks to fetuses. In this category, however, the benefits of the therapy may still outweigh the risks. GSK will be sending a letter to doctors with the updated information.

The data from both studies indicates heart-related birth defects, though rare, are more common among women who took Paxil in early pregnancy. GSK states: "The expectation is that in the general population, the risk of cardiovascular defects is about one per 100 infants."

According to GSK, the studies show a risk of heart-related birth defects as about 2% (2% and 1.5%) for women who used Paxil in early pregnancy. The cause of this increased risk is not clear, however. In fact, GSK states; "It's not clear whether there's a true causal association."

Most of the heart-related birth defects reported in the studies involved holes in the walls of the chambers of the heart (atrial and ventricular septal defects). According to the FDA: "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."

The FDA also states that early results from the two studies show women who took Paxil during the first trimester of pregnancy were about 1.5 to two times as likely to have a baby with a heart defect as all other women (using other antidepressants or none at all).

The FDA does indicate, however, that "the benefits of therapy may outweigh the potential risks to the fetus."

GSK emphasised this point by stating; "In the labeling, I think there's some important guidance for prescribers as well as patients to take note of.”

In addition, the drugmaker states: “The labeling now advises that patients who become pregnant while they're taking [Paxil] should certainly be informed of the potential harm to the fetus.Consideration should be given to discontinuing [Paxil] or perhaps switching to another antidepressant, unless the benefit that the mother is experiencing justifies continuing treatment. For women who intend to become pregnant or are in their first trimester of pregnancy, other treatments and options should be considered first before initiating Paxil.

So these are the recommendations that GSK and the FDA support to help put this information in a useful context for physicians as well as women to make well-informed treatment decisions."

According to GSK: "These studies that are referenced in the new labeling are largely updated analyses from the data that was the justification for the change in September. We have worked very closely with the FDA on the data interpretation, and what the labeling should say, and how to most quickly and effectively get this out into the public," she says. "It was a collaborative effort."

In any event, the results of the studies are significant and all women are well-advised to heed the enhanced warnings, and to proceed with extreme caution, and only after seeking medical advice, before taking Paxil if they are pregnant.

Antidepressants Can Affect Newborns

Tue, 17 May 2005 00:00:00 -0700

Women who take Prozac or certain other antidepressants late in pregnancy raise the risk that their babies will suffer jitteriness, irritability and serious respiratory problems during their first couple of weeks, researchers say.

Babies born to women taking antidepressants in the last three months of pregnancy were three times more likely to develop drug-related symptoms than those born to women who did not use the drugs or took them only in early pregnancy, according to a University of Pittsburgh study that pooled previous research.

The study was published in Wednesday's
Journal of the American Medical Association.

Most of the symptoms are mild and usually disappear after about two weeks, but some require intensive care hospitalization, the researchers said.

The drugs involved include Prozac, Paxil and other antidepressants known as selective serotonin reuptake inhibitors or SSRIs, and also serotonin norepinephrine reuptake inhibitors, which include Effexor.

At least 80,000 U.S. women yearly take the drugs during pregnancy, the researchers estimated.

Serious respiratory problems develop in perhaps one out of 100 infants born to these women, said Dr. Eydie Moses-Kolko, a psychiatrist who led the study.

The Food and Drug Administration and drug makers recently agreed to labeling changes on these drugs to include information about the symptoms, which some doctors call neonatal behavioral syndrome, or withdrawal syndrome.

Moses-Kolko said there has been little research on whether the drugs have any lasting effects in children, although one study found that affected newborns were developmentally normal at 8 months.

"I don't think this is cause for alarm," but patients and doctors should be aware of the risk, she said.

Women should talk to their doctors about reducing use of the drugs late in pregnancy but should also be aware that the risks of major depression might outweigh the short-term problems the drugs might cause in newborns, she said.

Paxil Lawsuit Paxil Lawsuit Birth Defect

Tue, 17 May 2005 00:00:00 -0700

Paxil Birth Defect Lawsuit / Lawyers

The lawyers and attorneys at our firm are currently representing families of children who have suffered Paxil birth defects. In 2005, the Food & Drug Administration (FDA) warned that the antidepressant Paxil had been linked to an increased risk of birth defects, and asked GlaxoSmithKline to modify the drug's labeling to reflect this risk. The Paxil birth defect risk is especially high if an expectant mother took Paxil during the first trimester of pregnancy. If you or someone you know was the victim of Paxil side effects, we urge you to contact one of our Paxil injury lawyers as soon as possible.

Paxil - known generically as paroxetine - was brought to market by GlaxoSmithKline in 1992, and by 2006, Paxil was the fifth most-commonly prescribed antidepressant in the US, with more than 19.7 million prescriptions. Paxil was approved by the FDA to treat symptoms of depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), panic disorder, generalized anxiety disorder (GAD), social phobia/social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Paxil was the first antidepressant formally approved in the US for the treatment of social anxiety disorder.

Paxil is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). SSRIs affect seratonin levels in the brain, a chemical neurotransmitter. Seratonin is produced in the brain on an ongoing basis and in response to pleasure-giving experiences, in a normally healthy system. SSRIs like Paxil have been linked to an increased risk of suicide when they are taken by young people. In addition to investigating claims for Paxil birth defects, our Paxil injury lawyers are also offering free evaluations to victims of other Paxil side effects, including suicidal behavior.

FDA Paxil Birth Defect Warnings

In September 2005, the FDA and GlaxoSmithKline alerted doctors about a new study on major birth defects seen in babies born to women who took the antidepressant Paxil during the first trimester of pregnancy. The alert was based on a study GlaxoSmithKline conducted of major birth defects in infants born to women who took antidepressants - including Paxil - during the first trimester of pregnancy.

In the study of more than 3,500 pregnant women, Paxil was linked to twice as many major birth defects as other antidepressants, according to the FDA. Most of the birth defects seen in the study were heart related; the most common heart malformations were ventricular septal defects, which are holes between the heart's two main pumping chambers. The FDA said GlaxoSmithKline would be updating the Paxil precautions section to include data from this study.

In December 2005, the FDA announced that it was requiring GlaxoSmithKline to add additional warnings about Paxil birth defects to the drug's prescribing information. The FDA took the action because the early results of two more 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 ranged in severity from those that were minor and resolved without treatment to those that caused serious symptoms and needed to be repaired surgically.

The FDA said 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.

The Paxil label was again changed to reflect the latest data from the two studies and to change the pregnancy category. The FDA had previously classified the Paxil birth defect risk as Category C (Risk of Fetal Harm Cannot be Ruled Out). The new Paxil labeling now classified the birth defect risk as Category D (Positive Evidence of Fetal Risk).

The FDA advised 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. The agency also said health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients.

The FDA also cautioned patients that Paxil should usually not be taken during pregnancy. Women taking Paxil who were pregnant or planned to become pregnant were advised to talk to their physicians about the potential risks of taking the drug during pregnancy. However, the FDA also said women taking Paxil should not stop taking it without first talking with their physician.

Legal Help for Victims of Paxil Related Birth Defects

If you know a child who has suffered from Paxil birth defects, or if you or someone you know experienced other serious side effects because of Paxil, we urge you call our law firm immediately. Our experienced Paxil side effects lawyers can make sure you or your loved one is compensated for your injuries. Please fill out our online form or call us at 1-800 LAW INFO (1-800-529-4636) for a free review of your case.

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