Birth Defect Lawyer Blog

A panel of experts at the federal Food and Drug Administration (FDA) has voted to loosen restrictions on a diabetes drug that has been linked to heart problems. The drug, rosiglitazone (brand name Avandia), was once one of the industry's highest sellers, with an estimated $3 billion in sales per year for its manufacturer, GlaxoSmithKline, until evidence in 2007 revealed that it increased the risk of heart problems. Now Avandia is used by just a few thousand people.

Recently, 13 out of 26 people on the FDA advisory panel voted to amend the restriction on sales, which had been imposed in 2010. The restrictions stated that Avandia could only be used as a last resort medication, after patients had not responded to other drugs, that it be sold only at certain pharmacies, and that physicians and patients must acknowledge that they understand the increased risk of a heart attack. Those who began taking Avandia prior to the imposed restrictions are not affected.

The panel's vote in favor followed the outcome of a review of a clinical trial conducted by the manufacturer, which purported to find that Avandia did not increase the risk of heart problems. Even so, some of the panel members who voted in favor continued to express reservations about the drug. The FDA is expected to follow the panel's lead, as it normally follows its advisory panels' recommendations.

It is fortunate for those who need the drug if Avandia does not pose a greater risk of heart attack or other heart problems. Unfortunately, that is not the case for many medications -- a pregnant woman who takes certain necessary medications, such as antiepileptic drugs -- has an increased risk of giving birth to a child with a birth defect. For instance, Depakote, one drug used to treat epilepsy and migraines, has been revealed to cause birth defects in certain animal studies, and shows evidence of causing birth defects in humans. As a result, Depakote went from being classified as FDA pregnancy category C -- only posing a risk to animal fetuses -- to pregnancy category D, a classification that shows it capable of greater harm. Any woman who takes this medication must take precautions, and must be fully informed of the risks by her physician before she proceeds.

If your child has a birth defect that you believe is due to your taking a dangerous antiepileptic drug while pregnant, you have the option of hiring an experienced attorney and filing a product liability lawsuit against the manufacturer and/or a medical malpractice lawsuit against your physician. You might argue in your product liability lawsuit that the manufacturer created an unreasonably dangerous drug, exposure to which caused your child's birth defect. In your medical malpractice lawsuit, you would argue that your physician had a duty to inform you of all of the risks of a potential treatment, yet failed to do so. As a result, you were unknowingly exposed to a dangerous drug and your child was born with a birth defect.

Continue reading "FDA Panel Votes to Remove Restrictions On Sales of Diabetes Drug Linked to Heart Attacks" »

A new study finds that pregnant women who take the antiepileptic medication valproate (brand name Depokate) are at a higher risk of having children who develop autism. Previous studies have also linked Depakote use to a higher risk of birth defects.

The study, conducted in the UK and published in the Journal of Neurology, Neurosurgery & Psychiatry, looked at over 500 pregnant women between 2000 and 2004. Of that number, roughly half had epilepsy, and all but 34 women took medication to keep their seizures under control. These women took carbamazepine (brand name Tegretol), valproate, and lamotrigine (brand name Lamictal). Later, researchers studied the potential effects of these medications on the women's children. Of the 415 available, 19 had been diagnosed with a developmental problem by the age of six years old, and three also had a physical disability. Of these 19 children, 12 children had a form of autism, and one had also been diagnosed with attention deficit disorder. Three children had attention deficit disorder by itself, and four children had a condition known as dyspraxia, where the individual suffers from a lack of physical coordination.

Children born to mothers with epilepsy were more likely to develop these physical and mental problems than children born to mothers without epilepsy -- 7.46% compared to 1.87%. Roughly 12% of children whose mothers who took valproate had developmental disorders, and 15% of children whose mothers took valproate plus other medication. Moreover, the higher the dose of valproate, the more likely the children were to have a neurodevelopment disorder. Overall, children of mothers who took valproate were six to 10 times more likely to develop physical or mental problems compared to children born to mothers without epilepsy, with boys being diagnosed three times more often than girls.

Experts throughout the world have expressed concern about the overuse of valproate. In the United States, only half of valproate prescriptions are for the treatment of epilepsy. The rest are for the treatment of migraines and psychiatric disorders.

By now, the dangers posed by valproate/Depakote, and even lamotrigine/Lamictal, should come as no surprise, given the other studies involving the drugs. However, it is possible that many pregnant women are completely unaware of these drugs' harmful effects and rely upon their physicians to inform them of the dangers. If you are one of those women and your child was born with a birth defect, you have the option of filing a medical malpractice suit against your physician. In order to be successful, you would need to make the case that your physician knew of the dangers -- or could have reasonably obtained the information -- of taking valproate while pregnant, but failed to inform you. Since physicians have a duty to inform, that would be a breach of duty to you, the patient. You would argue that as a result, you were exposed to valproate while pregnant and your child was born with a birth defect or has autism or attention deficit disorder.

Continue reading "A New Study Finds That Pregnant Women Who Take Depakote Are More Likely to Have Children With Autism and Developmental Delays" »

The struggle against birth defects has seen many celebrities and politicians step up to inform the public about potential causes. Now a quarterback bound for the Super Bowl can be added to the list. Colin Kaepernick, quarterback for the San Francisco 49ers, has another focus: a camp for children born with heart defects.

Camp Taylor was formed near Turlock, California after Kimberlie Gambino gave birth to a son with half a heart. As her son grew up, Gambino realized that he could not keep up physically with other children from school, and that he needed a place where he could interact with children who were like him. There was no such place in Northern or Central California, so Gambino created one. Her camp attracted Kaepernick, who grew up in Turlock, in part because Kaepernick himself had two older siblings who died of heart defects shortly after their birth. Kaepernick's parents later adopted him when he was five weeks old.

According to Gambino, Kaepernick has not only made at least one donation to the camp, but he also visited and met with the children. Last July, he attended a heart education class, and otherwise spent six hours playing, swimming, and being climbed on by the 150 children in attendance. Once Kaepernick became the starting quarterback for the 49ers, he began inviting camp children to games, and has donated some of the proceeds from his "Kaepernicking" T-shirts to the camp. Now that Kaepernick is Super Bowl-bound, Camp Taylor's profile will continue to rise, and hopefully more camps like it will be formed.

While it is encouraging to see programs set up to help children with heart defects, it is still better if birth defects could be avoided altogether. Heart defects have a variety of different causes, including environmental factors. For instance, heart defects have been linked to use of certain antiepileptic medications, like Depakote. Depakote has been labeled by the Food and Drug Administration as pregnancy Category D, which means that there is some risk to human fetuses associated with taking the medication.

If your child has a heart defect that you believe is due to your taking Depakote while pregnant, you have the option of filing a medical malpractice lawsuit and/or a product liability lawsuit. For the medical malpractice suit against your physician, you would argue that your physician had a duty to inform you of all of the risks associated with Depakote, but failed to do so. As a result, you were exposed to the medication while pregnant, and your child was born with a birth defect. For a product liability suit against the manufacturer, you would argue that the manufacturer had a duty to consumers to create as safe a drug as possible, but instead created a drug that was unreasonably dangerous. As a result, you were exposed to the drug while pregnant, and your child was born with a birth defect.

Continue reading "Super Bowl-Bound Quarterback Raises Awareness of Camp For Children With Heart Defects" »

A recent press release by a drug research firm has found that the "epilepsy market" is set to increase by nearly $1 billion by 2016. That may be good news for manufacturers of antiepileptic drugs, but may be bad news in terms of birth defects risk. Some studies have suggested that pregnant women who take certain antiepileptic drugs, especially during the first trimester, are at a greater risk of having babies with birth defects.

The press release announces that the market will increase from $2.9 million in 2011 to $3.7 million in 2016, thanks to the expanding number of "third generation" antiepileptic drugs, including lacosamide (brand name Vimpat), perampanel (brand name Fycompa), eslicarbazepine acetate (brand name Zebinix/Stedesa), and ezogabine/retigabine (brand name Potiga/Trobalt). However, "second generation" antiepileptic drugs such as evetiracetam (brand name Keppra/E Keppra) and lamotrigine (brand names Lamictal or Lamictal XR) will remain dominant on the market through 2021.

The press release notes that an "unmet need" remains with regard to seizures in 20 to 30% of epilepsy patients that are inadequately controlled by current medication. New research will be performed to determine how best to serve these patients' needs.

Currently, the evidence linking newer antiepileptic drugs to a higher risk of birth defects is mixed. One Danish study in 2011, for instance, found that there was no connection between the drugs and a higher risk of birth defects, but noted that the "number of individual exposures are too small" to make a conclusive finding. However, other studies have found that there is a higher risk of birth defects when taking certain antiepileptic medications, particularly valproate (brand name Depakote). It remains to be seen whether further research will find that more second and third generation drugs pose a risk.

If your child has a birth defect that you believe is due to your having taken antiepileptic medication while pregnant, you have the option of filing a lawsuit against both the manufacturer and your physician. You would file a medical malpractice suit against your physician if you had reason to believe that he or she was aware of the dangers -- or should have been aware -- and never informed you. A physician has a duty to inform his or her patients of all of the risks associated with treatment, so that the patient can make an informed decision about whether or not to go forward. In a medical malpractice suit, you would argue that the physician breached his duty to inform you of the birth defects risk, that this breach resulted in your injury (through exposure), and the damage that resulted was your child's birth defect.

Continue reading "Epilepsy Drug "Market" to Increase to $3.7 Billion By 2016" »

For those who suffer from depression, bipolar disorder, or other imbalances of the brain, one doctor proposes using acupuncture as an alternative to antidepressant medication. Pregnant women who choose this approach may have the added benefit of reducing the risk of their children being born with birth defects.

Dr. Patrick Massey argues that recent research has found that while antidepressants can help those with severe depression, they have less obvious benefits for those with milder depression. In clinical tests, antidepressants were no more effective for people with milder depression than sugar pills functioning as placebos. Dr. Massey thinks that this is due to many factors contributing to depression besides brain chemistry.

Dr. Massey points to a recent study in the Canadian Journal of Psychiatry, which looked at a compilation of studies that examined the effectiveness of acupuncture at relieving moderate depression for people across a broad age span. The study ultimately found that acupuncture was at least as effective as antidepressants, and when coupled with antidepressants, might reduce some of the side effects. Dr. Massey cautions that the weight of medical research on the subject is not conclusive, but notes that at the very least, it shows that acupuncture is an effective therapy for those with depression. In addition, exercise and meditation have also been shown to be effective alternatives.

While the studies on acupuncture as an alternative are promising, those with depression should do their research before making the choice to go with acupuncture over antidepressants. That includes working with their physician to get an accurate assessment of their mental health so that they can make an informed choice. However, if you are pregnant with moderate depression, and you opt to use acupuncture instead of antidepressants, you might have the benefit of lowering your child's risk of being born with a birth defect. That is because certain antidepressants have been linked to causing a variety of birth defects, especially if women take them during the first trimester. Antidepressants like Depakote have been classified as Pregnancy Category D drugs - evidence of harm to human fetuses - by the Food and Drug Administration as a result.

If your child has a birth defect that you believe could be due to your taking antidepressants while pregnant, you might consider filing a product liability lawsuit against the manufacturer and/or a medical malpractice suit against the physician who prescribed you the medication. For the product liability lawsuit, you would make the argument that the manufacturer had a duty to consumers to create as safe a drug as possible, and the manufacturer breached that duty by designing a drug that was unreasonably dangerous. The breach caused your injury (through exposure to the antidepressant's harmful effects) and the damage was your child's birth defect. For the medical malpractice lawsuit, you would argue that your physician had a duty to inform you, the patient, of all of the potential harms of your course of treatment. Your physician breached this duty by failing to inform you of all of the harmful side effects of your antidepressants, even though he or she knew that you were pregnant. As a result, you would argue that you were injured through exposure, and the damage was your child's birth defect.

Continue reading "Doctor Points to Studies Suggesting That Acupuncture As Effective at Treating Moderate Depression As Antidepressants" »

This blog has previously discussed lawsuits filed against Grunenthal, the German manufacturer of Thalidomide, which was a morning sickness pill linked to severe birth defects. Thalidomide was prescribed in the 1950s to many pregnant women in the United States and throughout the world during their first trimester. While Thalidomide was never approved for use in the U.S., many believe that physicians were still given the drug to prescribe. The drug was taken off of the market in 1961 after evidence of severe birth defects was revealed. However, those who filed the lawsuits -- primarily those who were born with severe birth defects -- have claimed that Thalidomide knew about the birth defects as early as 1955, yet chose to keep them a secret.

For a long time, Grunenthal has strongly denied that it knew about the birth defects sooner, even refusing to be part of a settlement with an Australian whose mother had taken Thalidomide. However, recently, Grunenthal might have changed its tune. The company issued a rare apology to those whose mothers took Thalidomide during the 1950s and early 1960s. Grunenthal's chief executive apologized for not "reaching out" all these years and said it was due to "the shock that your fate has caused in us."

Those who had been adversely affected by Thalidomide refuse to be placated. Freddie Astbury, who was born without arms or legs, claims that not only should Grunenthal apologize, but that it should also offer compensation to those with birth defects. Another person affected by Thalidomide pointed out that while Grunenthal settled one lawsuit in Germany in the 1970s, the fund that was set up was too small to help those expected to live, on average, into their 80s.

While Thalidomide is no longer sold on the market, other potentially dangerous drugs are still sold and prescribed in the U.S. every day. The antidepressant Depakote, for instance, has been linked to a variety of birth defects. If your child was born with a birth defect that you believe was due to prescription medication that you were prescribed while pregnant, you have the option of filing both a medical malpractice lawsuit and a product liability lawsuit. In both cases, your main objective will likely be to receive a money award that will help pay for your child's care for the rest of his or her life. It is therefore important that you provide an accurate assessment of your child's physical and mental limitations for the jury. Calculating someone's care for a lifetime can be difficult, since it means projecting costs decades into the future. Oftentimes, medical malpractice and product liability lawsuits settle before they reach the point of a jury verdict. If you decide to settle, you still need to have those calculations ready to ensure that you are getting an amount that will serve your child's needs.

Continue reading "German Manufacturer of Pregnancy Drug Linked to Birth Defects Issues First Apology in Fifty Years" »

In a new study, researchers determined that antiepileptics were the drugs most commonly prescribed to those newly diagnosed with bipolar disorder, as one of three lines of therapy. While their findings are promising in that they show how antiepileptics bring relief to bipolar patients, they are also cause for concern. Other studies have shown that certain antiepileptics increase the risk of birth defects if taken by a woman while pregnant, especially during the first trimester.

Researchers from the healthcare advisory firm Decision Resources examined the claims of more than 95,000 diagnosed, drug-treated bipolar disorder patients. They found that antiepileptics such as lamotrigine (also known by its brand name Lamictal) are popular first-line options for treating bipolar symptoms, and can be more tolerable than lithium, while valproic acid (also known by its brand name Depakote) can be effective for treating patients who experience acute manic episodes.

Physicians have also prescribed "atypical antipsychotics," or second-generation antipsychotic tranquilizing drugs, to treat bipolar disorder. The most common atypical antipsychotics prescribed were quetiapine (also known by its brand name Seroquel) and aripiprazole (also known by its brand name Abilify).

Both Abilify and Seroquel have been classified by the Food and Drug Administration as Pregnancy Category C, which means that studies conducted on animals have found evidence of harm to the fetus, but no controlled studies have yet been conducted on humans. Therefore, the benefit of the drug might outweigh the risk. However, Depakote has been classified as Pregnancy Category D, which means that there has been positive evidence of human fetal risk based on adverse reaction data from studies or investigations. A Category D drug could still have benefits in spite of the risks. This blog has discussed possible links between Depakote and birth defects.

If you were prescribed Depakote or one of the atypical antipsychotics while pregnant, and your child was born with a birth defect, you could file a lawsuit. You could file both a medical malpractice suit against your physician and a product liability suit against the manufacturer. For the medical malpractice suit, you would claim that your physician had a duty to inform you, the patient, of the possible problems associated with your course of treatment so that you could make an informed decision as to whether or not to proceed. By not informing you, your physician breached this duty. Because of the breach, you were injured through exposure to the harmful effects of the medication, and the result was your child's birth defect.

Continue reading "Study Finds That Antiepileptic Drugs Are Frequently Prescribed to Treat Bipolar Disorder" »

This blog has discussed studies that show an increased risk of birth defects for those who take certain antiepileptic drugs, such as Topamax or Depakote. These studies found that pregnant women who were prescribed Topamax during the first trimester of pregnancy were more likely to give birth to children with certain birth defects, specifically cleft lip and cleft palate. Depakote's effects were even more widespread, increasing the risk of six different types of birth defects, including spina bifida. Other studies have linked antiepileptic to lower IQs in children.

Likewise, antidepressants have also been shown to increase the risk of birth defects. Studies have linked them to everything from slower head growth to heart defects.

Because of the concerning findings, the Food and Drug Administration (FDA) reclassified Topamax and Depakote as Pregnancy Category D drugs, a downgrade from Pregnancy Category C. Pregnancy Category C meant that while the drugs showed harmful effects to animals, no controlled studies had yet shown harm to humans. Pregnancy Category D means that controlled studies have shown that Topamax and Depakote posed a health risk to human fetuses, but still had potential benefits. Meanwhile, antidepressants such as fluoxetine, sertraline, and bupropion (more commonly known as Wellbutrin) have been classified as Pregnancy Category C drugs, while paroxetine and imipramine are in Pregnancy Category D.

Although these precautions have been taken, for some like Senator Chuck Schumer of New York, it still is not enough. Senator Schumer has called for the FDA to require clearer warning labels on prescription medications that warn pregnant women about the risk these drugs pose to their fetuses. Senator Schumer's goal is to reduce the number of babies born addicted to prescription medications, but it has the effect of helping them in the area of birth defects as well.

When most people file product liability lawsuits, they often do not consider the adequacy of the product's warning label. Yet adequacy of the warning label is one of the key factors for determining whether the product is defective and its manufacturer is strictly liable for whatever damages was caused. An adequate warning label is generally in an obvious location, is easy to read, and accurately describes the product's dangers. If your child was born with a birth defect that you believe was due to your taking prescription medications, and you do not have sufficient evidence that the manufacturer could have produced a less dangerous drug, you could argue that the warning label did not provide a sufficient warning. Had the warning been sufficient, you would not have taken the drug.

Continue reading "Senator Chuck Schumer Calls for the FDA to Impose Clearer Warning Labels on Prescription Medications" »

In a follow-up to "New Epilepsy Drugs May Have Lower Birth Defect Risk," a different study published by The Lancet Neurology in June concludes that four of the most common antiepileptic drugs may increase the risk of birth defects if taken by women early in their pregnancy, and even more so if the dosages are higher.

While the Danish study from May examined lamotrigine (Lamictal), oxcarbazepine (Trileptal), gabapentin (Neurontin), and levetiracetam (Keppra), the current EURAP study focused on valporic acid (Depakote), carbamazepine (Tegretol), Lamictal, and phenobarbital. Researchers in the new study found that of the four antiepileptic drugs, Depakote posed the greatest risk to fetal health.

Though past studies have noted the threat of Depakote, this is the first study to examine the threat of antiepileptic drugs based on the dosage prescribed. It examined women who received antiepileptic treatment in their first trimester: 1,402 women were exposed to Tegretol, 1,280 women to Lamictal, 1,010 to Depakote, and 217 to phenobarbital. With each drug, an increase in birth defects corresponded with an increase in the dosage. When prescribed at 300 mg, Lamictal produced the lowest rates of birth defects. Tegretol had the lowest rate of birth defects below 400 mg. Depakote and phenobarbital had the highest rate of birth defects regardless of dosage.

Antiepileptic drugs have been linked to cleft lips and cleft palates. This study is significant in being the first to give physicians insight into which dosage levels are safe. Thus, physicians can help prevent more birth defects by prescribing a safe dose for pregnant women.

If your physician has prescribed an antiepileptic drug that you believe to be the cause of your baby's birth defect, you might consider filing a lawsuit for medical malpractice and/or for products liability. For a medical malpractice lawsuit, you would need to show that your physician had a duty to you as a pregnant woman to prescribe a safe dose of medication. By failing to do so, he or she breached that duty, and the breach was the actual or proximate cause of your baby's birth defect. Establishing the duty should not be a problem, but establishing breach may be more difficult. You would need to show that your physician did not act reasonably according to the standards of the medical community. He knew or should have known that the dosage he prescribed was dangerous, yet he failed to alter the dose or to warn you of the dangers. Since studies examining dosage levels are just starting to emerge, you might have trouble establishing that your physician did not act with due care.

Continue reading "New Study Finds That Larger Doses of Epilepsy Drugs Can Cause Birth Defects" »

A study published in the New England Journal of Medicine found evidence of lower cognitive functioning in young children who were exposed to antiepileptic drugs while in the womb. The study was entitled "Cognitive Function at 3 Years of Age After Fetal Exposure to Anti-Epileptic Drugs."

Previous studies on animals had found that fetuses exposed to antiepileptic drugs could develop cognitive abnormalities; however, the effects of these drugs on human fetuses were still unknown. The study observed women between the years 1999 to 2004 who were taking the anti-epileptic drugs carbamazepine, lamotrigine, phenytoin (Dilantin) or valproate (Depakote). Researchers then compared the cognitive functioning of 309 children by the time they were 3 years of age.

The study found that children who had been exposed to valproate in the womb had considerably lower IQ scores compared to those exposed to other antiepileptic drugs. Children who had been exposed to valproate (Depakote) in utero scored an average of 9 points lower IQ than children who were exposed to lamotrigine; 7 points lower than those exposed to phenytoin (Dilantin), and 6 points lower than exposed to carbamazepine. The study also found that larger doses of valproate, were correlated with lower IQ scores. In sum, the study found a significant link between exposure to valproate (Depakote) in the womb and reduced cognitive function by 3 years of age.

The FDA has classified many antiepileptic drugs as pregnancy category D drugs, which means that there is positive evidence of risk to human fetuses. The FDA strongly recommends that pregnant women not use medications in category D unless the benefits of the drug outweigh the risk to the fetus. Many antiepileptic drugs are in pregnancy category D, including Depakote, Dilantin, and Topamax.

Continue reading "Valproate, Antiepileptic Drugs Linked to Lower IQ" »

According to a recent study published in the American Journal of Obstetrics and Gynecology, increasing numbers of women are taking medications during pregnancy. Studies have already found that some drugs such as valproate, isotretinoin, thalidomide and phenobarbital may increase the risk of birth defects. However, not enough information is known about the effects of most medications on unborn babies. As a result, many pregnant women could be taking medications that pose a risk to the fetus. On the other hand, insufficient information may cause pregnant women to avoid taking medications they may need.

The recent study was a collaboration between researchers from Boston University's Slone Epidemiology Center, Harvard School of Public Health, and the Centers for Disease Control and Prevention. The researchers analyzed data from interviews with 30,000 women that were conducted from 1976 to 2008; the interviews were about the prescription and over-the-counter medications these women were taking.

The study found that during the first trimester, 70 to 80 percent of women said they took at least one medication. By the year 2008, 50 percent of women said they took at least one prescription drug. (Generally, the risk of birth defects is highest during the first trimester). The researchers also found that in the past 30 years, women's use of prescription drugs in the first trimester increased more than 60%. In addition, the number of women taking four or more medications during the first trimester has multiplied threefold. The study also found that use of medication increased with a woman's age and education level; and that medication use was higher among non-Hispanic white women, compared to women of other races and ethnicities.

Allen A. Mitchell, MD, director of Boston University's Slone Epidemiology Center and the study's lead author said, "These data identify prescription medications that are currently most commonly used and therefore urgently require research on their risks and safety; they also reinforce the need for ongoing surveillance regarding medication use in pregnancy and its consequences." He added, "Not only is it critical to identify how many over-the-counter and prescription medications are taken by pregnant women and what those specific medications are, but it is also important to know how use of medications changes over time."

Continue reading "Study Reports Increasing Medication Use Among Pregnant Women " »

A recent study has found that pregnant women who take the epilepsy drug valproic acid (brand names Depakote and Depakene) during the first trimester increased their risk of having a baby with serious birth defects. The study was performed by researchers at the University of Groningen in the Netherlands and was published in The New England Journal of Medicine in June 2010.

The study found that babies exposed to valproic acid during the first trimester were 12.7 times more likely to be born with spina bifida (a condition where the spinal canal fails to close properly) compared to babies not exposed to the drug. The study also found that babies exposed to valproic acid during the first trimester were 2.5 more times more likely to be born with an atrial septal defect (heart defect), 5 times more likely to have cleft palate, 7 times more likely to be born with craniosynostosis (premature fusion of the skull bones that restricts skull and brain growth), and twice as likely to have polydactyly (an extra digit on each hand)

"These findings provide further evidence to avoid valproic acid, if possible, in pregnant women and [for doctors] to discuss with girls and women of childbearing potential the risk of the drug for the unborn child," said lead author Lolkje T.W. de Jong-van den Berg of the University of Groningen.

Past studies have also linked valproic acid to birth defects and other developmental problems. In April 2009, Dr. Kimford Meador of Emory University was lead author of a study on valproic acid that was published in The New England Journal of Medicine. The study associated valproic acid exposure in utero to lower IQ scores at 3 years of age.

Continue reading "Valproic Acid Linked to Spina Bifida, Other Birth Defects" »

A new study published in the February issue of Psychiatric Services found that the drug valproate is still commonly prescribed to women of childbearing age, despite evidence linking valproate with a higher risk of birth defects.

Valproate is an anticonvulsant drug commonly used to treat epilepsy, bipolar disorder and migraines. It is also known as Depakote, Depakene, valproate sodium and valproic acid. However, in 2009, the Food and Drug Administration issued a warning that fetuses exposed to valproate have an increased risk of neural tube defects, heart defects, skeletal and organ malfunctions, cleft palate, and fetal death. For example, spina bifida (a condition where the spinal canal does not close) is a severe birth defect associated with valproate use.

Findings released in December 2010 from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study showed that mental deficits were more frequent in children who were exposed to valproate. Prior NEAD research also found that 3-year-olds exposed to valproate in utero scored an average of 6-9 points less on IQ tests, compared to children exposed to other antidepressant medications.

The authors of the new study wrote, "Over 20% of childbearing-aged women receiving mood stabilizers were treated with valproate, although increasing data on the reproductive toxicity of this agent compel consideration of other non-antipsychotic mood stabilizers as first-line choices." The authors recommended that patients and health care providers be informed about the reproductive risks that come with taking mood stabilizers, and added that "reducing the rate of first-line valproate use among women of childbearing age creates an opportunity for prevention of reproductive toxicity."

Continue reading "Valproate Commonly Prescribed Despite Increased Risk of Birth Defects" »