Drug Safety Developments

Was I properly warned about the side effects of Depakote/Depakene/Depacon?

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A

 

As discussed in my last article, "Should I have been prescribed Depakote / Depakene / Depacon?", it is extremely important that these drugs are properly prescribed, given their devastating potential fetal side effects.

Additionally, any time that Depakote / Depakene / Depacon was prescribed to a female patient, doctors should have warned the woman about the possible fetal side effects of “major congenital malformations, particularly neural tube defects (e.g., spina bifida)” and / or “decreased IQ scores.”

However, according to a recent Reuters article, many pregnant women taking these drugs do not feel as though they were adequately warned of the potentially life-altering side effects.

While the drug manufacturer, Sanofi, claims that the labels provide sufficient warnings, many women disagree. 

The aforementioned article discusses a recent public hearing held by the European Medicines Agency (EMA) on patients' experiences with drugs containing valproic acid--the main active ingredient in Depakote, Depakene, and Depacon.  The article provides the following information:

[R]ecent surveys in the United Kingdom showed almost 70 percent of women taking the drug had not received adequate advice.

Clare Pelham, speaking on behalf of Britain’s Epilepsy Society, said warnings on medicine packages and leaflets were insufficient and that patients needed “tailored conversations” with healthcare professionals.

In the United States, as revisions of FDA drug labels are released and new or increased warnings are added to those labels, doctors should keep current with the prescribing information for the medications they use to treat their patients.

Often when a new FDA drug label is released with increased warnings of particularly severe or life-threatening possible side effects, a “Dear Doctor” letter is also issued to providers, so that they may adequately warn patients.

The information provided by the FDA should lead to more adequate warnings of the potential devastating side effects of these drugs.

Such warnings are warranted if:

1. the female patient who was prescribed Depakote / Depakene / Depacon was of childbearing potential; and,
2. Depakote / Depakene / Depacon was deemed “essential to the management of her medical condition,”

Her doctor should then have warned her that:

1. the drugs could cause “major congenital malformations, particularly neural tube defects (e.g., spina bifida)” and / or “decreased IQ scores”; and,
2. “effective contraception” was necessary so as to prevent pregnancy and any fetal exposure to these drugs.

Any warning that fails to address these key points could be deemed inadequate, and potentially serve as the basis of a medical malpractice case if an unborn child was exposed to the drugs, then was born with one of the aforementioned side effects.

For more information on Depakote / Depakene / Depacon and the issue of adequate warnings, visit our website.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

 

 

Should I have been prescribed Depakote / Depakene / Depacon?

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

Depakote, Depakene, and Depacon are often prescribed for bipolar disorder, epilepsy, and sometimes migraine headaches.  The common active ingredient in these four drugs is valproic acid, or valproate.

These drugs have been shown to cause significant fetal birth defects when taken by pregnant women, especially during the first trimester of pregnancy. 

Here is a list of the possible fetal side effects of these drugs, according to the FDA Drug Labels:

• Major congenital malformations, particularly neural tube defects (e.g., spina bifida)
• Decreased IQ scores following in utero exposure
• Increased rates of other major congenital malformations, such as craniofacial and cardiovascular defects:
  
  • cleft palate
  • heart defects (such as atrial septal defect)
  • polydactyly (multiple fingers or toes)
  • craniosynostosis (premature closure of sutures in skull)
  • hypospadias (abnormal location of urethra in males)

Given the potential life-altering side effects of these drugs, it is important for doctors to ensure that they are prescribing the drug appropriately.

If prescribing one of these drugs to a woman of "childbearing age," the doctor needs to ensure the following:

1.  the drug is absolutely essential to the management of the patient's condition; and,
2.  no other drugs would provide adequate management or treatment of the patient's condition.

Concerning the first point, the FDA drug labels provide the following warning:

Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate.

In regard to the second point, the drug labels provide this second warning:

Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.

If the doctor failed to ensure the aforementioned criteria were met, then Depakote, Depakene, or Depacon may have been improperly prescribed.

Such improper prescription could potentially serve as the basis of a medical malpractice lawsuit against the prescribing doctor if it resulted in the birth of a child with one of the aforementioned detrimental side effects.

Another key element to consider when prescribing Depakote, Depakene, or Depacon to women of childbearing age will be discussed in my next post.

In the meantime, visit our website to learn more about the issue of proper prescription concerning these drugs.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

 

AbbVie Required to Pay Depakote Victim $15 Million for Birth Defect

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

AbbVie, which spun out of Abbott Laboratories in 2013, was recently held responsible for failing to adequately warn that their bipolar disorder drug, Depakote (valproic acid), could cause severe birth defects when taken by pregnant women.

The $15 million will be awarded to a 10-year-old boy, Stevie Gonzalez, who was born with spina bifida after his mother took Depakote while pregnant.  

As a result of the Depakote-related birth defect, Gonzalez is confined to a wheelchair and has already undergone twelve surgeries.  The money was awarded to Gonzalez in order to pay for past and future medical bills and care.

Though AbbVie claimed the potential side effects of Depakote were properly disclosed, the jurors in federal court in Illinois decided otherwise.

While AbbVie was held responsible for inadequately warning of Depakote's potential for birth defects, they were not required to pay punitive damages as well.  In other words, the did not think that the Plaintiffs provided clear and convincing evidence that AbbVie's conduct concerning Depakote amounted to malice, oppression, or fraud.

At this time, there are nearly 700 similar cases pending in U.S. courts against AbbVie concerning Depakote-related birth defects.

In addition, drugs similar to Depakote--such as Depakene, Depacon, and Stavzor--have also been shown to cause birth defects when taken during pregnancy.

We will continue to monitor the medical literature as well as the legal news concerning the pending and upcoming Depakote - birth defect cases.

If you or someone you know has given birth to a child with spina bifida or other neurological birth defects after taking Depakote, Depacon, Depakene, or Stavzor while pregnant, we invite you to complete our free case evaluation.

You may also view our website for more information on Depakote / Depakene / Depacon / Stavzor.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

French Families Sue the Manufacturer of Depakote for Birth Defects

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A

 

Depakote, Depakene / Depakine (Europe), Depacon, and Stavzor are anti-epilepsy drugs that contain valproic acid, which has been known to cause various birth defects when used by pregnant women.  Such possible birth defects include facial deformities, developmental issues, and an increased risk of autism.

The link between these drugs and birth defects have been known since the early 1980's.  However, the article "Over 14,000 women took Sanofi epilepsy drug despite fetus risk: ministry" reports that "More than 14,000 pregnant women in France took Sanofi's anti-epilepsy drug, Depakine, between 2007 and 2014.

As a result, hundreds of babies that were exposed to these drugs while in utero were either stillborn, or born with congenital birth defects during these seven years in France, alone.

Sanofi claims that during that time, the information provided to doctors and patients warned of the possibility of physical and mental defects in the children of pregnant women.  

However, a preliminary investigation in Paris was recently launched in order to evaluate the truth of this statement by looking into the authorization and marketing of Depakine at the time.

As a result, parents of the children who were born with birth defects due to Depakine exposure are filing lawsuits in France (see note, below).  They contend that adequate warnings concerning the possible side effects of the drug were not in place.

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NOTE:

The case against Sanofi brought in France is a class-action suit; the first of which has been brought in France that deals with a health issue, according to the article, "Families bring class action against French drug maker Sanofi."

However, any cases filed on behalf of birth defect victims in the United States would be handled individually, rather than as a class-action lawsuit.

In fact, since about the year 2000 all successful drug injury lawsuits have been, by necessity, individual lawsuits for the simple reason that the judges will no longer "certify" any drug injury class action. 

This is because despite the fact that the individuals who were harmed used the same drug, they all have varying medical histories, duration of use, side effects, severity of injury, etc.  In other words, there are simply too many differences and not enough common ground amongst such individuals to lump them into a class-action suit. 

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To address these inadequate warnings, updates to the drug's packaging will be made within the next several months to more clearly warn of the drug's dangerous potential for the children of pregnant women.

Additionally, France is responding by setting aside an initial 10 million euros ($10.7 million) for claims concerning injuries suffered from Depakine use.

According to the article, "France sets up fund for Sanofi epilepsy drug victims," Health Minister Marisol Touraine told lawmakers in the lower house of parliament that "The 10 million euros are a starting point...In future years, the sums should be much higher."  She also stated, "I regret that Sanofi didn't seek an amicable settlement as a matter of principle. I hope (Sanofi) will change its position."

We will continue to monitor the medical literature and legal news concerning the Depakote litigation and its development, here and abroad.

In the meantime, you can visit our website to learn more about Depakote / Depakene / Depacon / Stavzor.  In addition, if you or someone you know have taken one of the aforementioned drugs and gave birth to a child with birth defects, we encourage you to complete our Free Case Evaluation form.  

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Manufacturers of Depakote Face Lawsuits at Home and Abroad

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

Recently, the drug manufacturers of Depakote (valproate) and its derivatives have come under legal fire for failing to warn about the possible side effects of the drug, and blatantly concealing warnings in order to increase their profits.

In the United States, AbbVie Inc. (formerly Abbott Laboratories) manufactures Depakote, Depakine, and Depacon.  In Europe, however, the drug is called Depakine and is manufactured by Sanofi.  

Depakote is used to treat seizures and bipolar disorder.  When used by pregnant women, it has the potential to harm their unborn children by causing still births, slowed neurological development, and congenital birth defects.

From the article on Reuters.com, "Sanofi will accept epilepsy drug blame if court rules that way," we learn the following information about Depakote:

Evidence grew toward the end of the 20th century that the drug could cause deformities in unborn children, but it was not until 2014 that the European Medicines Agency decreed it should be prescribed only when other treatments had failed, and only with accompanying evidence that patients had been informed of the risks during pregnancy.

Given that Sanofi apparently chose to protect their profits--rather than the health and safety of those who need their drugs--many children and families have suffered needlessly.  However, Sanofi declared in October of 2016 that they will accept responsibility for their actions.  At the present time, measures to determine proper compensation for victims is taking place in France.  

We hope to see AbbVie Inc. / Abbott Laboratories follow in Sanofi's footsteps and accept the blame for their actions, then work towards compensating those who have been negatively affected by Depakote.

Presently, lawsuits are also being filed against Abbott Laboratories for failing to provide accurate information to doctors concerning the use of Depakote.  It has been determined that like Sanofi, Abbott Labs intentionally withheld important warning information pertaining to the dangers of Depakote in the name of protecting its profits.

The article "Mo. Appeals Court Upholds $38 Million Depakote Birth Defect Verdict" (paid subscription required) provides these details:

A Missouri appeals court has upheld a $38 million verdict issued in favor of a girl who was born with spina bifida and other birth defects after being exposed to Depakote in utero, finding the evidence supported the jury’s finding that Abbott Laboratories failed to adequately warn doctors that the drug had an increased risk of birth defects versus its competitors and was significantly more dangerous for use in women of childbearing age.

We will continue to monitor the medical literature for more information on arising lawsuits against Sanofi and AbbVie.

In the meantime, you may learn more about Depakote and its possible side effects on our website.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

 

Epilepsy Drugs in Pregnancy Tied to Developmental Delays in Children

Quoted from http://consumer.healthday.com/disabilities-information-11/misc-birth-defect-news-63/antiepileptic-drug-pregnancy-epilepsia-release-batch-473-678329.html

Epilepsy Drugs in Pregnancy Tied to Developmental Delays in Children

Large Norwegian study followed offspring for up to 3 years

 

THURSDAY, July 18 (HealthDay News) -- The children of women who take drugs to treat epilepsy during pregnancy may be at increased risk for physical and mental developmental delays early in life, a large, new study finds.

Epilepsy is fairly common among women of childbearing age, and the use of antiepileptic drugs by pregnant women ranges from 0.2 to 0.5 percent.

In this study, researchers recruited Norwegian mothers at 13 to 17 weeks of pregnancy. For more than 61,000 children, mothers provided details about motor development, language skills, social skills and autistic symptoms at age 18 months. At 36 months, mothers provided that information for more than 44,000 children.

The researchers found that 333 of the children were exposed to antiepileptic drugs in the womb. At 18 months of age, these children were more likely to have motor skills problems and traits of autism. At 36 months of age, these children were more likely to have problems with motor skills and sentence skills, and traits of autism.

The children exposed to antiepileptic drugs also had an increased risk of birth defects, according to the study appearing July 18 in the journal Epilepsia.

[Article continues at original source]

Related articles

Depakote Or Depakene Taken During Pregnancy May Cause Congenital Malformations Or Birth Defects Such As Neural Tube Defects Like Spina Bifida

Depacon / Depakene / Depakote: 400% Increased Risk Of Birth Defects Compared To Other Anti-Seizure Medications Used By Mothers With Epilepsy