August 2013

The objectives of a study called “The Frequency of Neonatal Morbidity After Exposure to Antiepileptic Drugs in Utero:  A Retrospective Population-Based Study”, written from the Department of Perinatology-Neonatology, Maribor Teaching Hospital in Slovenia, were to determine fetal growth retardation, cerebral hemorrhage, neonatal withdrawal symptoms, and other general malformations in offspring exposed to antiepileptic drugs in the womb.  The target population for this study consisted of women from the northeastern part of Slovenia.  Information on 37 epileptic mothers taking AEDs during pregnancy, 32 epileptic mothers not taking AEDs, and 211 mothers healthy in pregnancy was collected between 1998 and 2002, and total of 270 newborns and their health were assessed.

Author Burja S. from the above article explains the results of the study, “In the group not exposed to antiepileptic drugs (32 neonates), two (2.9%) had germinal matrix hemorrhage grade I, one (1.4%) was small for date (SFD) and one (1.4%) had feeding problems. In the group exposed to antiepileptic drugs (37 neonates), nine (13%) had germinal matrix hemorrhage grade I, six (8.6%) were SFD, five (7.24%) had feeding problems, four (5.8%) had withdrawal symptoms and three (4.3%) “macro” congenital anomalies. Among neonatal problems in the control non-exposed group of newborns of 211 healthy women we identified 23 (10.9%) newborns who were SFD, 5 (2.4%) cases with germinal matrix hemorrhage grade I, 5 (2.4%) cases with major congenital malformations and 7 (3.3%) cases with feeding problems.”

This study shows a clear connection between antiepileptic drugs and their increased risk of neonatal morbidity.  A significant connection was made between cerebral hemorrhage in newborns with exposure to Carbamazepine therapy during development.  Most doctors would recommend the use of one drug to control a pregnant woman’s epilepsy.  At times, the use of only one drug (monotherapy) is not an option, due to epilepsy that is not easily controlled.

The use of more than one drug (polytherapay) may be the only viable option for treatment.  The use of two or more antiepileptic drugs is associated with a higher risk for congenital malformations in the offspring of epileptic women.

Because so many women were not made aware of the risks for birth defects AEDs carry, a number of AED lawsuits are being filed.  One drug found to be particularly dangerous is Depacon, an AED containing sodium valproate, but many studies show danger associated with a range of different antiepileptic drugs.

If you used Depcaon or another AED during pregnancy and your child was born with a birth defect, you and your family may be entitled to significant financial compensation for the injury your child sustained through no fault of his or her own.

Our team of Depacon lawyers has the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help!

(855) 452-5529

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

Today there are many studies available exploring the side effects of antiepileptic drugs (AEDs) taken during pregnancy.  One concern in such cases involves the risk of teratogenesis, which is the malformation of the fetus and/or embryo.  Most studies primarily focus on the initial pregnancy; there is less information available in regards to subsequent pregnancies in women who continued taking AEDs associated with fetal malformation.  One study exploring such cases performed by the Departments of Medicine and Neurology, at the University of Melbourne is titled “Teratogenesis in repeated pregnancies in antiepileptic drug-treated women.”  This study analyzed data, collected by The Australian Register of Antiepileptic Drugs in Pregnancy, including 1,243 women with 2,637 total pregnancies, between 1999 and 2010.  Among the 2,637 pregnancies, 1,114 had been completed before initial enrolment in the register.

The analysis revealed that “Women taking any AED who had given birth to a malformed baby in their first enrolled pregnancy and who continue taking the same drug were at increased risk of having a malformed offspring in their next pregnancy (35.7% vs. 3.1%; odds ratio [OR] 17.6; 95% confidence interval [95% CI] 4.5-68.7).”

An odds ratio (OR) of 17.6 means that children born to mothers who used AEDs were found to be 17.6 times as likely to be born with birth defects, compared to children whose mothers did not use the drug.

Analysis of one such AED, valproate (VPA), the active ingredient in Depacon Depakene, and Depakote, and others, revealed that women taking VPA were “more likely to have malformed fetuses in their next pregnancies than those who had taken VPA without fetal abnormalities (57.2% vs. 7.0%, OR 17.8; 95% CI 2.7, 119.1).”  Other AEDs studied, showed similar trends to the effects of VPA, however VPA was the only drug that showed a statistically significant difference.  Similar trends, although not statistically significant, were found “when considering the pairings of the most recent pre-enrollment pregnancy and the following one. If a woman had two or more pregnancies that resulted in AED-associated fetal malformation, the types of malformation were often different.”

The study concluded that “Women whose last pregnancy resulted in a fetal malformation have a substantially increased risk of having further malformed fetuses if they become pregnant again while taking the same AED, particularly VPA.”  This implies that additional maternal factors, such as genetics, could possibly predispose fetuses to VPA-associated malformations.

This information, along with knowledge of prior pregnancy outcomes, should be strongly considered when treating women suffering from epilepsy with AEDs, if they plan on having future pregnancies.

Because many women who used Depacon (and other AEDs containing sodium valproate) during pregnancy were not adequately informed about the risk for birth defects Depacon carries, a number of Depacon lawsuits have been filed against the manufacturer, Abbott Laboratories.

If you or a loved one used Depacon and your child was born with a birth defect, you may be entitled to significant financial compensation for the undue injury your family has sustained.  Contact our team of Depacon lawyers for a free, no-obligation case consultation at your convenience.  We are here to help!

(855) 452-5529

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

There are many concerns regarding women of childbearing age who suffer from epilepsy.  There is a clear connection between antiepileptic drugs and their ability to cause harm to a developing fetus or embryo.  Reduced fertility and other menstrual cycle disorders have been linked with exposure to certain antiepileptic drugs.  In an article titled “Teratogenic Potential of the Newer Antiepileptic Drugs: What is Know and How Should This Influence Prescribing”, written from the Regional Epilepsy Center, University of Milan Medical School at the San Paolo Hospital in Milan, Italy, author Palmieri C. states “most AEDs induce the cytochrome P450 (CYP) enzymatic system, altering the metabolism of sex hormones and contributing to the failure of oral contraceptives. Pregnancy represents, in this context, the most critical period because of the well known teratogenic potential of all established AEDs.

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For most of these drugs, no specific patterns of malformations have been identified, although during the past few decades basic knowledge has been acquired, particularly concerning the mechanisms of AED-induced teratogenesis and related risk factors.”

Newer generations of AEDs have shown to have safer qualities than the older generation of antiepileptic drugs.  They have shown positive signs with what the body does to the drugs, making them more stable during pregnancy.  The newer generation has also shown to have a lower potential for interactions with other drugs, which can lead to unwanted complications.

Palmieri C. further explains “They are also less likely than the older AEDs to be metabolised to compounds that are teratogenic. Furthermore, most of them do not possess antifolate properties.”  AEDs may inhibit the absorption of Folic acid in the body.  Folic acid is a naturally occurring substance found in foods such sunflower seeds and collard greens. Many doctors would recommend their patients start a folic acid regiment before and during their pregnancy.

Some studies suggest that many of the newer antiepileptic drugs do not carry the folic acid depletion effect on the body, but It is important to be informed about the risks involved with any medications being taken and to know that the effects of antiepileptic drugs on the body can vary for individuals.

AED Birth Defect Lawsuits

Since Abbott Laboratories, the manufacturer of Depacon, one AED found time and again to be particularly dangerous because it contains sodium valproate, has failed time and again to notify patients and doctors appropriately of the risks Depacon use poses to developing babies, a number of Depacon lawsuits have been filed.

If you or a loved one used an AED such as Depacon during pregnancy and your child was born with a congenital malformation, please do not hesitate to contact our team of Depacon lawyers.

(855) 452-5529

justinian@dangerousdrugs.us

We have the experience, skills, and resources required to fight even the largest pharmaceutical companies and win the justice you deserve.  Call today and see how we can help.

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

The purpose of a study done by the Faculty of Medicine, University of Rijeka, titled “Epilepsy and Pregnancy: Antiepileptic Drugs Effects on Pregnancy”, was to determine the amount of antiepileptic drugs being used in pregnant women with epilepsy and to analyze possible complications during pregnancy and delivery.  This study was conducted in the University Hospital Center Rijeka, and was done over a ten-year period.  One hundred and fifty one pregnant epileptic women were evaluated in this study.  Author Sepić-Grahovac D explains the results, stating “During the study period, 185 children (male 95) were born. Twenty-four miscarriages were recorded in women with the diagnosis of epilepsy in their medical history. In 117 of women, the onset of epilepsy occurred before the age of 20 years. AEDs were used in 111 of patients, in 77% of them as monotherapy. The most frequently used AEDs were carbamazepine (36.2%), valproate (29.3%), phenobarbitone (24.1%). Folic acid was used in 25 pregnancies only, however, during 2002 folic acid was used in 15 pregnancies (yielding 22 in total). Apgar score was equal or higher than 8/8 in 96% of children. No specific teratogenic effects were observed.” (emphasis added)

In this study, the administration of folic acid to women showed improvements regarding the risks of major congenital malformations.  This makes sense because AEDs have previously been shown to inhibit the absorption of folic acid in the body, and this may have to do with an increased risk for the offspring to develop MCMs.  Many doctors recommend their patients to start a Folic acid regiment before and during the entirety of their pregnancy.  Further, monotherapy has also been associated with a decreased risk of major congenital malformations in the offspring of epileptic women, but in some cases, the use of only one drug does not properly control the patients’ epilepsy and the implementation of two or three drugs are necessary.

One AED frequently associated with an increased risk for birth defects is Depacon (also Depakene, Depakote), manufactured by Abbott Laboratories.  Depacon use time and again is linked to serious birth defects of both the heart and brain, but Abbott Laboratories does not make clear these risks to its customers.

As such, a number of Depacon lawsuits have been filed.  If you used Depacon and your child was born with a congenital malformation, please do not hesitate to contact our team of Depacon lawyers for more information or for a free, no-obligation case consultation.

(855) 452-5529

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

Antiepileptic drugs (AEDs) have shown to increase the risk of major congenital malformations (MCMs) in the offspring of epileptic drugs.  AEDs have shown to have harmful effects on a developing fetus or embryo.  Most doctors would recommend treatment using only one antiepileptic drug, which has shown to have a decreased effect on the rate of major congenital malformations.  However, some women have epilepsy that is not easily controlled and the induction of multiple medications is their only option.  Author Barrett C., from the Epilepsy Research Foundation in London, wrote an article titled “Epilepsy and Pregnancy: Report of an Epilepsy Research Foundation Workshop”, where he states “Several factors have been identified to account for the increased risk, including the direct teratogenic effects of antiepileptic drug (AED) therapy, indirect effects of these drugs by interfering with folate metabolism, genetic abnormalities in drug or folate metabolism, and possibly an arrhythmogenic effect of maternal drug therapy on the embryonic heart, leading to ischaemia in developing tissues.”

It has not been shown that epileptic episodes during pregnancy have any harmful effects on the developing fetus, and more studies are needed to be in order to conclude the psychomotor development of children exposed to antiepileptic drugs during development.  Barrett C. further explains that “Retrospective studies suggest that impaired cognitive development may be associated with maternal drug therapy, particularly valproate. There is an urgent need to evaluate these risks and, with this in mind, several prospective registers have been set up to collect data from pregnancies in women with epilepsy.” (emphasis added)

The risks involved with AEDs are well known, but the impact it has on the body runs on an individual basis.  Talk to your doctor or healthcare provider about AEDs so you can make an informed decision regarding your treatment.

One AED containing sodium valproate frequently associated with birth defects is Depacon (also Depakene, Depakote), manufactured by Abbott Laboratories.  Sadly, Abbott Laboratories has failed time and again to warn women of the risks for birth defects Depacon carries, and unknowingly placed their developing children at unnecessary risk.  Because of this negligence, a number of Depacon lawsuits have been filed around the world.

If you or a loved one used Depacon or another AED during pregnancy and your child was born with a congenital malformation, do not hesitate to contact our team of Depacon lawyers, for your family may be entitled to significant financial compensation.

For more information or a free, no-obligation case consultation, you may reach our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

The connection between antiepileptic drugs and their ability to cause damage to a developing fetus or embryo is well documented.  Antiepileptic drugs (AEDs) are clearly connected to an increased risk of major congenital malformations in offspring exposed to the drugs during development.  Author Oguni M, from the Department of Pediatrics, Tokyo Women’s Medical University, at Shinjuku-Ku, in Tokyo wrote an article titled “Epilepsy and Pregnancy”, where the author states, “Since 1963, the association between antiepileptic drugs (AEDs) and congenital malformations in the offspring of women with epilepsy has received attention. A number of articles reported affirmative as well as some negative findings regarding an increased risk of congenital malformations. Although a consensus has not been regarding the presence of the specific malformation syndromes in relation to individual AEDs, such as fetal hydantoin syndrome, it is evident that women taking AEDs carry a two- to sevenfold higher risk of congenital malformations than do the general population.”

Fetal hydantoin syndrome (also known as fetal dilantin syndrome) is a birth defect caused by Phenytion or Carbamazepine to a fetus due to the teratogenic effects of these drugs.  Antiepileptic drugs have also shown to inhibit the absorption of folic acid (a natural compound found in foods such as spinach and sunflower seeds), so many doctors recommend their patients start a folic acid regiment for the entirety of their pregnancy.

The use of only one drug to treat epilepsy of women who wish to bear children is considered the safest method, for the introduction of two or three medications to control epilepsy has been associated with elevated risks that the offspring with develop major congenital malformations.  However, for many women, more than one drug is needed to control their epilepsy so polytherapy is the only viable option.  Author Oguni M. further explains that “In most recent studies, special attention has been placed on polytherapy, including the specific AED, or AED combinations, and high AED serum concentrations, responsible for the higher risk of congenital malformations. Based on these cumulative results, therapy guidelines for women of childbearing age with epilepsy have been established.”  Most of the data and studies done on this subject shows that epileptic episodes during pregnancy will likely not cause harm to the developing fetus.

Since many AED manufacturers have failed to warn users of the risks these drugs carry for birth defects, a number of AED birth defects lawsuits have been filed around the world.  If you used an AED and your child was born with a birth defect, you may be entitled to financial compensation for the undue injury sustained by your family.

I have the experience, resources, and skills required to win the justice you deserve in your Depacon lawsuit.

(855) 452-5529

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

The connection between antiepileptic drugs and their ability to cause harm to a developing fetus or embryo has been well documented in the medical world.  Many doctors would advise their epileptic patients’ to be on as few antiepileptic drugs (AEDs) as possible.  This is especially important for epileptic women who are trying to conceive.  Author Kaplan PW, from the department of Neurology, Johns Hopkins Bayview Medical Center, wrote an article titled “Reproductive Health Effects and Teratogenicity of Antiepileptic Drugs”, where he states “Women with epilepsy are less likely to bear children than women in the general population, and although this reduced fertility can be attributed in part to effects of the disease itself, the effects of antiepileptic drugs (AEDs), including changes in reproductive endocrine function, are also a factor. Conversely, some AEDs interact with oral contraceptives and can increase the risk for contraceptive failure and unplanned pregnancy.”

The fetus or embryo exposed to antiepileptic drugs is at a much higher risk for major congenital malformations (MCMs) than a fetus which is not exposed during development.  Some studies suggest that a Folic Acid regiment during pregnancy can decrease the risk of MCMs.  AEDs have shown to inhibit the absorption of Folic Acid in the body, a possible cause for major congenital malformations.  Author Kaplan PW. further explains, “In utero exposure to some AEDs may also be associated with increased risk for impaired cognitive function in the growing child. Clearly, possible long-term effects on reproductive health and pregnancy outcomes require careful attention when AED therapy is being considered for a patient with childbearing potential.”

Antiepileptic drugs are now being used to treat a wider range of conditions, such as bipolar disorder and depression, so the dangerous side effects will inevitably be passed on to a greater part of the population.

Since the manufacturer of one particularly dangerous AED called “Depacon” (Abbott Laboratories) has failed to warn women of the risk for birth defects associated with their product, a number of Depacon lawsuits have been filed around the world.

If you used Depacon and your child was born with a birth defect, it may have been the result of in utero exposure to sodium valproate, the active ingredient in Depacon Depakene, and Depakote.

For a free, no-obligation Depacon lawsuit consultation, contact our team at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve, from even the largest pharmaceutical companies.

(855) 452-5529

justinian@dangerousdrugs.us

Call today and see how we can help.

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

Antiepileptic drugs (AEDs) are associated with a wide range of side effects, and the increased risk of major congenital malformations (MCM) to the offspring of women exposed to AEDs during pregnancy is very well known.  In a study called “Factors Influencing the Risk of Abnormal Pregnancy Outcome in Epileptic Women: A Multi-centre Prospective Study”, done by the Department of Obstetrics and Gynecology, University Hospital Nijmegen, in the Netherlands, R.P. Steegers-Theunissen states “We studied pregnancy outcome in preconceptionally recruited epileptic and control women in a multi-centre prospective non-intervention study at two university hospitals and three general hospitals. We evaluated 225 singleton pregnancies: 119 pregnancies of epileptic women who received either antiepileptic drugs (AEDs) (n = 99) or not (n = 20), and 106 pregnancies of controls.
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The main outcome measures were abnormal pregnancy outcome: major and minor congenital malformations, ectopic pregnancies, abortions; neonatal headcircumference; birth weight and birth length.”

The study showed that abnormal pregnancies and infants born with malformations were twice as likely with epileptic women, compared to the healthy controls, and there was a correlation found between the dosage of antiepileptic drugs given to the mother and the prevalence of abnormal pregnancies.

Author R.P. Steegers-Theunissen further explains “No significant effect in terms of the type, the number or the serum level of the AEDs could be established. The head circumference of infants of epileptic mothers was significantly smaller (0.7 (1.2, 0.28 cm) compared to controls. An effect on the outcome of pregnancy of maternal folate supplementation or of folate blood concentrations during the periconceptional period and first trimester of pregnancy could not be determined. The severity of maternal epilepsy and/or AED treatment influences pregnancy outcome.”  Many doctors have their epileptic patients start a folic acid regiment before and during their pregnancy, and since AEDs have shown to inhibit the absorption of folic acid in the body, some studies suggest Folic acid treatments lower the risk of MCM in the offspring of epileptic women.

Since the companies that make some of these AEDs have failed to explain these risks to patients and doctors, a number of AED birth defect lawsuits have been filed.  Abbott Laboratories, the manufacturer of Depacon, (a particularly dangerous AED containing sodium valproate) has failed time and again to make clear to women the risk Depacon poses to their developing babies, Depacon lawsuits are being filed around the world.

If you or a loved one used Depacon and your child was born with a birth defect, do not hesitate to contact our team of Depacon lawyers, for you may be entitled to compensation for the injuries your family has endured.

Our skilled team of Depacon lawyers has the experience, resources, and dedication to win the justice you deserve.  Call today and see how we can help.

(855) 452-5529

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

Some studies have shown that women with epilepsy have an increased risk for bearing children with major congenital malformations.  And, it has been shown many times that in utero exposure to maternal antiepileptic drugs (AEDs) exacerbates that risk.   The study described below aimed to clarify whether it was maternal epilepsy or in utero exposure to AEDs that was more responsible for birth defects.

Author Fried S. from the University of Toronto, Toronto, Ontario, Canada, wrote an article titled “Malformation Rates in Children of Women With Untreated Epilepsy: A Meta-Analysis”, to determine “if epilepsy per se represents a teratogenic risk”, that is, “To systematically review all studies investigating the occurrence of major malformation rates among children of treated or untreated women with epilepsy and non-exposed controls who do not have epilepsy.”  A random effects model was used for this case-control study, reporting malformations rates in children of women exposed or unexposed to antiepileptic drugs compared to children of nonepileptic mothers.  Author Fried S. claims “We found ten studies reporting results of untreated epilepsy (n = 400) and their non-epileptic healthy controls (n = 2492). Nine out of ten studies also reported results on 1443 patients exposed to antiepileptic drugs and their 2526 unexposed healthy controls. The risk for congenital malformations in the offspring of women with untreated epilepsy was not higher than among nonepileptic controls (odds ratio [OR] = 1.92; 95% CI 0.92-4.00). There was evidence of publication bias, thus with bias removed the OR was 0.99 (95% CI 0.49-2.01).”  The study also showed that children of epileptic mothers who were exposed to AEDs during pregnancy had higher incidences of major congenital malformations.

The above study did not conclude that a women’s epilepsy alone increases the risk of MCMs in her offspring, and suggests that former publications showed bias, which lead to premature conclusions.  Whether or not epilepsy alone puts a child at risk of developing MCMs, the medical world strongly agrees about the risks involved with antiepileptic drugs and their fetus damaging capabilities.  The use of Polytherapy (more than one antiepileptic drug to control seizures) has clearly shown to greatly increase the risk of MCMs, as compared to Monotherapy.  However, Monotherapy may not always be an option depending on how well the patients’ seizures can be controlled.  For many women, the use of 2 or 3 drugs are the only way they can control their epilepsy.

Due to the fact that the manufacturers of some of these drugs have failed to warn women of the risks AEDs pose to their developing babies, AED birth defects lawsuits have been filed around the world.  The chemical most frequently found to be the most dangerous is sodium valproate, the active ingredient in Depacon Depakene, and Depakote.

If you or a loved one used an AED during pregnancy and your child was born with a congenital malformation, you may be entitled to significant financial compensation for the suffering your family has endured.  For more information or a free, no-obligation case consultation, contact our team of  Depacon lawyers at the information provided below.

(855) 452-5529

justinian@dangerousdrugs.us

Our Depacon Lawsuit Information page is a great place to start if you have any questions about Depacon.

Cipro (ciprofloxacin), an antibiotic that has recently been linked to retinal detachment and other nerve disorders, came under fire last week as the US Food and Drug Administration rules that new warnings and usage guidelines be included on its packaging “to better describe the serious side effect of peripheral neuropathy”[1] or, nerve damage.

MedlinePlus, an online medical encyclopedia curated by the National Institutes of Health and the US National Library of Medicine explains peripheral neuropathy in this way:

“Peripheral nerves carry information to and from the brain. They also carry signals to and from the spinal cord to the rest of the body.

Peripheral neuropathy means these nerves don’t work properly. Peripheral neuropathy may be damage to a single nerve. It may be damage to a nerve group. It may also affect nerves in the whole body.”[2]

This warning label update applies to all oral fluoroquinolones, including “levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive),”[3] and the FDA warns that “This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.”[4] (emphasis added)

Many peer reviewed studies have previously shown associations between Cipro and rare, but serious side-effects affecting the central nervous system; it is about time that the labels were properly updated.

However, due to allegations that the manufacturer of Cipro (Bayer Healthcare Pharmaceuticals, Inc.) knew the risks associated with its product but failed to act, a number of Cipro retinal detachment lawsuits and Cipro nerve damage lawsuits are currently being filed.

If you or a loved one used Cipro and experienced retinal detachment or another Cipro side-effect, you may be entitled to significant financial compensation.  For more information, or for a free, no-obligation Cipro lawsuit consultation, please do not hesitate to contact our team of Cipro lawyers at the information provided below.

We have the experience, resources, and skills required to bring you the justice you deserve.  Call today and see how we can help!

(855) 452-5529

justinian@dangerousdrugs.us