September 18th, 2009 
Officials of GlaxoSmithKline Plc, the U.K.’s largest drugmaker, said in 2001 that a birth defect in the fetus of a woman taking its Paxil antidepressant likely was linked to the drug, according to court testimony.
After analyzing a 2001 e-mail from a Paxil user who aborted her fetus because it had a heart defect, Glaxo officials noted in company files they were “almost certain” the drug was related to the problem, Jane Nieman, a former Glaxo drug-safety executive, told a Pennsylvania jury.
“I don’t know who made that assessment, but it’s there,” Nieman testified in a videotaped deposition played yesterday for jurors. Nieman’s testimony came in the trial of another Paxil user’s lawsuit over birth defects suffered by her now 3-year-old son.
The state-court trial in Philadelphia is the first of more than 600 cases alleging Glaxo knew Paxil caused birth defects and hid those risks to increase profits. The drug, approved for U.S. use in 1992, generated about $942 million in sales last year, 2.1 percent of Glaxo’s total revenue.
The family of Lyam Kilker claims Glaxo withheld information from consumers and regulators about the risk of birth defects and failed to properly test Paxil. Lyam’s mother, Michelle David, blames Paxil for causing her son’s life-threatening heart defects.
Glaxo’s lawyers contend the London-based drugmaker isn’t liable for Lyam’s heart defects and acted responsibly in testing Paxil and updating safety information.
Glaxo officials learned about the woman’s experience with Paxil in 2001 after she e-mailed the company seeking information on studies done about Paxil’s links to birth defects, said Nieman, who was the company’s director for evaluation and training for global clinical safety at the time.
The woman, whose identity was withheld by Glaxo, said she’d been taking Paxil for anxiety when she found out she was pregnant, Neiman said. The woman praised Paxil as a “miracle drug” that provided relief from panic attacks, the executive added.
“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,” the woman said in the e-mail. “I love everything this drug has done for me. Please contact me as soon as possible. Please don’t forget about me.”
Nieman said she didn’t know who at Glaxo made the note in the company’s database that the aborted fetus’ heart defects were likely linked to the woman’s Paxil use.
“Somebody from GSK filled that in,” she said. “There’s a possibility someone made a mistake and checked the box wrong.”
Lawyers for Kilker allege Glaxo mounted a marketing campaign to persuade doctors to write more Paxil prescriptions for pregnant women dealing with anxiety.
The drugmaker undertook that campaign while withholding information about birth-defect reports from doctors, the family contends.
The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 2007-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).
Related
- Antiseizure Drug Increases Birth Defect Risk
Using the antiseizure medication valproic acid (Depakote) in the first trimester of pregnancy significantly increased the risk of six types of birth defect, European researchers found.
In an analysis of more than 98,000 pregnancies, the risk of the serious spinal defect known as spina bifida was increased more than 12 times for children of mothers on the drug, according to Lolkje T.W. de Jong-van den Berg, of the University of Groningen in the Netherlands and colleagues.
The risks of another five defects were increased between two and seven times, the researchers reported in the June 10 issue of the New England Journal of Medicine.
Those findings support recommendations by the American Academy of Neurology to avoid the use of the drug in pregnancy, the researchers wrote. In the clinic, they continued, the risks of birth defects associated with valproic acid should be routinely considered in women of childbearing age.
Looking at past studies and comparing them against an antiepileptic-study database set up by the European Surveillance of Congenital Anomalies (EUROCAT), the researchers found that six malformations were significantly linked to a woman’s valproic acid use in her first trimester of pregnancy. In addition to spina bifida, the children of these women faced a more than doubled risk of a heart condition known as an atrial septal defect and a five-fold risk of cleft palate.
The risk of hypospadias — a condition in which the opening of the urethra in boys is on the underside of the penis rather than the end — went up nearly five times with a mother’s use of the drug. Craniosynostosis, a condition in which the bones of the skull close too early, was nearly seven times as common in these children, and polydactyly, a condition in which a child has more than five fingers per hand, was more than twice as common.
On the other hand, the researchers found, absolute risks of malformations remained low, ranging from 0.1 percent for craniosynostosis to 0.7 percent for hypospadias. The absolute risk for spina bifida associated with valproic acid was 0.6 percent, they found.
The researchers also cautioned that the study was observational, so it could not indicate anything about cause and effect. They were also unable to say anything about possible confounding by indication, since the drug is used for several clinical indications, or the effects of varying dosages.
- Most Pregnant Women Never Tested for the Most Common Birth Defect
Three out of five women who have given birth to a child with a congenital heart defect (CHD) — the number-one birth defect and leading killer of infants and newborns — were never tested for the defect during pregnancy. This is according to a survey just released by Little Hearts, Inc.
These findings come just as CHD Awareness Week begins (Feb. 7 – 14). The Little Hearts survey found that 60 percent of parents did not know their child had a CHD until after giving birth — because the mothers were not tested for heart defects during pregnancy.
Of these parents, nearly three out of four (71.6 percent) wished they had known their child had a CHD during pregnancy — mostly because they would have given birth at a hospital more equipped to handle the care of newborns with a CHD (41.6 percent).
“Congenital heart defects kill more children than childhood cancer, and yet, pregnant women are not routinely tested — and newborns are not routinely screened — for this defect,” says Lenore Cameron, President and Executive Director, Little Hearts, Inc. “Early detection is absolutely critical to the successful treatment of congenital heart defects and, in countless cases, it saves lives.”
Those families that did know their child had a CHD before giving birth (40.0 percent) reaped tremendous benefits from knowing in advance:
- Three out of five (59.5 percent) said they gave birth at a hospital more equipped to handle the care of newborns with a CHD
- One in five (19.8 percent) prepared themselves mentally and emotionally for the arrival of a seriously ill child
- Others did their homework: 14.9 percent of respondents said they arranged for a pediatric cardiologist in advance of their baby’s arrival, and 5.8 percent said that knowing in advance was most beneficial because it gave them time to do research on CHDs during the pregnancy
More Survey Results
- Four out of five respondents (81.7 percent) said neither parent of the heart child had any family history of CHDs
- Giving birth to a child with a CHD was more common for women in their 30s (65.2 percent) than in any other age group
- Three out of four respondents (76.1 percent) said the mother did not take prescription drugs (which is considered a CHD risk factor) while pregnant with the heart child
- Almost all respondents (96.4 percent) have only one child with a congenital heart defect; 3.6 percent have two or more children with a CHD
Nearly three out of five respondents (58.0 percent) said their heart child has two or more CHDs; 42.0 percent said their heart child has one CHD
- The most common CHD among children of respondents was Hypoplastic Left Heart Syndrome (30.3 percent), a very serious heart defect that occurs when the left side of the heart does not develop completely
- Most Pregnant Women Never Tested for the Most Common Birth Defect
Three out of five women who have given birth to a child with a congenital heart defect (CHD) — the number-one birth defect and leading killer of infants and newborns — were never tested for the defect during pregnancy. This is according to a survey just released by Little Hearts, Inc.
These findings come just as CHD Awareness Week begins (Feb. 7 – 14). The Little Hearts survey found that 60 percent of parents did not know their child had a CHD until after giving birth — because the mothers were not tested for heart defects during pregnancy.
Of these parents, nearly three out of four (71.6 percent) wished they had known their child had a CHD during pregnancy — mostly because they would have given birth at a hospital more equipped to handle the care of newborns with a CHD (41.6 percent).
“Congenital heart defects kill more children than childhood cancer, and yet, pregnant women are not routinely tested — and newborns are not routinely screened — for this defect,” says Lenore Cameron, President and Executive Director, Little Hearts, Inc. “Early detection is absolutely critical to the successful treatment of congenital heart defects and, in countless cases, it saves lives.”
Those families that did know their child had a CHD before giving birth (40.0 percent) reaped tremendous benefits from knowing in advance:
- Three out of five (59.5 percent) said they gave birth at a hospital more equipped to handle the care of newborns with a CHD
- One in five (19.8 percent) prepared themselves mentally and emotionally for the arrival of a seriously ill child
- Others did their homework: 14.9 percent of respondents said they arranged for a pediatric cardiologist in advance of their baby’s arrival, and 5.8 percent said that knowing in advance was most beneficial because it gave them time to do research on CHDs during the pregnancy
More Survey Results
- Four out of five respondents (81.7 percent) said neither parent of the heart child had any family history of CHDs
- Giving birth to a child with a CHD was more common for women in their 30s (65.2 percent) than in any other age group
- Three out of four respondents (76.1 percent) said the mother did not take prescription drugs (which is considered a CHD risk factor) while pregnant with the heart child
- Almost all respondents (96.4 percent) have only one child with a congenital heart defect; 3.6 percent have two or more children with a CHD
Nearly three out of five respondents (58.0 percent) said their heart child has two or more CHDs; 42.0 percent said their heart child has one CHD
- The most common CHD among children of respondents was Hypoplastic Left Heart Syndrome (30.3 percent), a very serious heart defect that occurs when the left side of the heart does not develop completely
- Migraine drugs don’t up birth defect risk: study
A study in nearly 70,000 pregnant women has found no link between migraine drugs called triptans and the risk of birth defects.
However, the researchers did find a “slight increase” in the risk of excessive bleeding during labor, and the failure of the uterus to contract normally after delivery, for women who used the drugs while pregnant.
Triptans are among the most powerful drugs used for migraine; others include aspirin, Excedrin, and ibuprofen.
While as many as three in 10 women may develop migraines during their childbearing years, women often shy away from using such drugs during pregnancy because of safety concerns, according to study co-author Katerina Nezvalova-Henriksen of the University of Oslo in Norway and her colleagues.
However, the authors of the study in Headache note, untreated migraine may itself carry risks for mother and child; some studies have linked it to pre-eclampsia, a potentially deadly pregnancy complication.
“While it is important to exert caution when using any medications during pregnancy, this study indicates” that pregnant women can either start or continue taking triptans without “any major risk” of miscarriage, premature delivery, or other bad outcomes, the authors conclude.
Nezvalova-Henriksen and her team studied nearly 70,000 women. Two percent, or 1,535, had used sumatriptan (Imitrex), rizatriptan (Maxalt), zolmitriptan (Zomig), or eletriptan (Relpax) in pregnancy.
Less than one percent — 373 women — had used the drugs before getting pregnant but not during pregnancy.
The overall birth defect rate, which encompasses everything from large birthmarks to serious heart problems, was the same among women who had taken triptans during pregnancy and those who didn’t have migraines: 5 percent. Among those who had used triptans in the past but not during pregnancy, it was slightly higher: 6 percent.
The women who used triptans were also more likely than non-triptan users to take other drugs during pregnancy, including acetaminophen (Tylenol) with codeine and non-steroidal anti-inflammatory drugs such as ibuprofen.
However, the rate of major birth defects – such as serious problems of the limbs or internal organs — was 3 percent for all three groups. That rate – about one in 33 births – is about what would be expected for all birth defects in the general population.
The researchers did find that women who used triptans in their second or third trimester were more likely to develop a condition called atonic uterus, in which the uterus fails to contract back to its normal size after delivery. This is the leading cause of excessive bleeding after delivery. They were also more likely to lose significant amounts of blood during labor and delivery.
And during pregnancy, they were more likely to suffer from vomiting than women who had never used the drug; they were also more likely to develop pre-eclampsia or eclampsia, and more likely to have deficiencies in the B-vitamin folate.
While many women who suffer migraines will experience improvements in their symptoms after their first trimester, Nezvalova-Henriksen and her team note, those whose symptoms don’t improve by then aren’t likely to get better.
- High Levels of Weed Killer in Drinking Water Linked to Birth Defects: Not Disclosed to Public
According to an investigative report published in the Huffington Post, a weed killer linked to birth defects and used extensively throughout the country on farms and golf courses is seeping into our nation’s drinking water supply at alarming levels, which exceed federal safety limits in four states. But the public is kept in the dark about the hidden dangers in the drinking water.
The weed killer is an herbicide named, atrazine and is manufactured by the Swiss company, Syngenta. When the EPA renewed approval for atrazine to be used in the U.S., the agency imposed new testing requirements on the company, requiring the company to test the levels of atrazine in the water of about 150 watersheds on a weekly basis. The results are sent to the EPA, state regulators and local water companies, but they are not made available to the public. Neither the EPA nor the water companies are legally required to do so.
Under the Federal Safe Drinking Water Act, the EPA is only required to make public, the testing results conducted by state regulators and state regulators only test the drinking water, up to a maximum of four times per year. In practice, the state testing is infrequent and doesn’t provide complete information about temporary, but harmful spikes in the levels of atrazine in the drinking water.
The Huffington Post Investigative Fund obtained the records of the test results conducted by Syngenta from 2003 through 2008, through the Freedom of Information Act, and found alarming average yearly levels of atrazine in the states of Illinois, Indiana, Ohio, and Kansas, as well as temporary spikes that exceeded safety levels. The levels detected would have triggered an automatic notification to water customers, but since the results did not come from state tests, customers weren’t notified of the danger.
The EPA says it does not consider atrazine a health hazard and that it complied with all applicable laws regarding reporting test results to the public. Although it’s true the EPA found that the herbicide is “not likely” to be a carcinogen; the agency does officially consider atrazine to be a potential hormone disruptor.
Additionally, several peer-reviewed scientific studies found that atrazine was potentially harmful to developing fetuses. One study found that birth defect rates in the United States were highest for women who conceived during periods of atrazine spikes in the water supply.
There are approximately 35 different types of CHDs. Some may be treated with surgery, medicine and/or devices, such as artificial valves and pacemakers. In the last 25 years, advances in the treatment of heart defects have enabled half a million U.S. children with serious CHDs to survive into adulthood. However, many cases of sudden cardiac death in young athletes are caused by undiagnosed CHDs and childhood-onset heart disease.
There are approximately 35 different types of CHDs. Some may be treated with surgery, medicine and/or devices, such as artificial valves and pacemakers. In the last 25 years, advances in the treatment of heart defects have enabled half a million U.S. children with serious CHDs to survive into adulthood. However, many cases of sudden cardiac death in young athletes are caused by undiagnosed CHDs and childhood-onset heart disease.
