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The Depakote injury attorneys at the Drug Law Center are now investigating claims and building cases for compensation for our clients who have been injured by the seizure disorder drug.
Depakote (divalproex sodium) is a seizure disorder medication that is often used concomitantly with other seizure drugs. Depakote has been effective in treating manic episodes including manic-depression (bipolar disorder) and the prevention of migraines. Unfortunately, the drug has serious side effects including causing severe liver damage that could result in death. The Food and Drug Administration issued a safety communication in May 2013 warning pregnant women, or those wishing to become pregnant, to avoid taking Depakote, Stavor, Depacon, and its generic form because of the potential of birth defects.
History of Depakote
Depakote and its generic form divalproex sodium have been available in the U.S. medical marketplace since 1983 as a prescription medication for the treatment of epilepsy. However, the drug was soon used for “off-label” purposes. In 1995, the FDA approved Depakote for treating manic episodes including manic-depression (bipolar disorder). The following year (1996), divalproex sodium and Depakote tablets were FDA approved to treat migraine headaches.
By September 2000, the FDA issued a directive to Abbott Laboratories to make warning label revisions on Depakote tablets after numerous reports of patients taking the medication developing life-threatening pancreatitis (inflammation of the pancreas). Two years later (2002), the drug maker launched an extended release form of Depakote used as an adjunctive and single treatment for epilepsy and seizures in adults.
Finally, in January 2007 additional safety labeling revisions were approved by the Food and Drug Administration to advise pregnant women, or those wishing to become pregnant, about the potential risk development of congenital malformations when fetuses were exposed to the drug in utero. It was during this time that the drug was classified as a Category C medication during pregnancy meaning that adverse effects were detected in animal studies.
This widely prescribed medication has been used for many off-label purposes that have resulted in hepatic failure leading to death. Typically, hepatic (liver) problems occur most commonly in the first six months of receiving treatment.
Depakote Side Effects
Depakote and the generic form divalproex sodium have common side effects that range from mild to serious. These include abdominal pain, drowsiness, dizziness, nausea, abnormal weakness (asthenia), and anorexia. More severe side effects include:
- Abnormal thinking
- Ataxia (loss of ability to fully control body movements)
- Alopecia (complete or partial loss of body hair)
- Weight loss
- Skin rash
- Black, tarry stools
- Ringing in the ears
- Unusual bruising or bleeding
- Difficulty in thinking
- Shaking of the feet, hands, arms, or legs
- Rapidly changing mood
- Emotional overreaction
- Muscle pains and aches
- Mental depression
- Abnormal dreams
- Unexpected change in personality
- Frequent urination
- Lack of coordination
- Joint degenerative disease
- Chest pain
- … many other side effects
Depakote and the Emergency Room
Overdosing on divalproex sodium (Depakote) often requires immediate emergency assistance. The most common symptoms associated with overdosing on the drug include fainting, a change in or loss of consciousness, and irregular or slow heart rate.
Depakote Black Box Warnings
The Food and Drug Administration (FDA) requires drug makers to carry “black box warnings” when labeling medications including Depakote (divalproex sodium). These warnings provide valuable information to doctors prescribing the drug and the patients who can better understand the serious side effects in adverse reactions the medication might cause.
The Depakote black box warning on the product’s labeling reveals that the drug has the potential of causing serious liver damage that could lead to death, especially in children who are two years and younger who take the medication. The potential risk of severe liver damage appears to be higher within the first six months of usage. However, some patients have experienced severe liver damage after they stopped taking the drug.
In 2000, the FDA required Abbott Laboratories to revise their black box warning when a correlation was revealed between taking Depakote (divalproex sodium) and the development of life-threatening pancreatitis. Some patients rapidly developed pancreatitis and died quickly after symptoms were recognized. The black box warning states that some individuals developed pancreatitis even though they had been taking the medication for only a short time.
The black box warnings indicate that patients with a history of liver disease should avoid taking Depakote (divalproex sodium). The drug should be avoided if the patient suffers from progressive degenerative diseases of the central nervous system like Alpers’ disease (syndrome) that tends to occur most often in children and infants.
Taking Depakote (divalproex sodium) can cause significant harm including the development of birth defects to an unborn baby. Serious birth defects are common for pregnant women taking the medication. This includes neural tube defects and spina bifida, and other conditions that affect the brain and spinal cord. These defects can begin developing within the first months of pregnancy, often before the mother knows she is pregnant.
The FDA has issued warnings stating that women during their childbearing years taking Depakote should use effective birth control methods to avoid pregnancy. Research studies show that the medication can pass and breast milk. However, no reports of harm have been identified in breastfeeding infants. However, the manufacturer suggests talking to your health care provider about any potential risks of breastfeeding while taking the drug.
The consumption of alcohol while taking Depakote, (divalproex sodium), or Depakote ER has the potential of increasing side effects alter the nervous system including impaired judgment, difficulty with concentration, dizziness, and drowsiness. Because of that, it is imperative to avoid or limit the amount of alcohol consumption when receiving treatment with the medication.
There are numerous drugs that interact with Depakote (divalproex sodium) causing serious side effects including toxicity. The most common drugs that interact with Depakote include:
- Ativan (lorazepam)
- Doan’s Pills (salicylates)
- Coumadin (warfarin)
- Tegretol (carbamazepine)
- Rifadin (rifampin)
- Elavil (amitriptyline)
- Felbatol (felbamate)
- Topamax (topiramate)
- Pamelor (nortriptyline)
- Banzel (rufinamide)
- Anafranil (clomipramine)
Additionally, specific anticonvulsants, hydantoins, and barbiturates could potentially interact with divalproex sodium or Depakote. In fact, using a barbiturate concomitantly with Depakote can increase toxicity levels while decreasing the potency of the drug to the point where it is rendered ineffective.
Suicidal Ideation and Behavior
In 2008, the Food and Drug Administration alert the public about anti-epileptic medications including Depakote indicating that users were at an increased potential of developing suicidal ideation (the thought of suicide) and behavior (committing suicide). Subsequently, the FDA required the pharmaceutical company to update their black box warnings to include information about the elevated potential risk.
Withdrawing from Depakote
Ceasing treatment using Depakote without guidance from the health care provider could cause serious withdrawal symptoms, side effects or other issues. Suddenly stopping the use of any seizure drug including Depakote being prescribed to treat epilepsy could cause status epilepticus (serious unexpected seizures that do not stop).
Depakote Drug Maker Pleads Guilty
In 2012, Abbott Laboratories were part of an investigation launched by the Department of Justice who alleged that the company had misbranded Depakote. The claims by the Justice Department revealed that they believe Depakote was illegally promoted for “off-label” uses that were not approved by the FDA. The drug maker admitted to misbranding the medication and subsequently pled guilty to a misdemeanor. In addition to the criminal plea, Abbott Laboratories agreed to settle civil and criminal claims with the government for $1.5 billion.
Personal injury attorneys who specialize in product liability and medical product defects are usually successful at resulting Depakote lawsuits because it the medication can be proven to be unreasonably dangerous. Since the FDA first approved the medication in 1983, many plaintiffs have filed and resolved Depakote lawsuits in both federal and state courts after making allegations of serious side effects and birth defects.
- $38 Million Awarded to Family in Successful Depakote Birth Defect Lawsuit
Minnesota, MN (June 2015) – The family of a Minnesota girl was awarded $38 million by a Minnesota jury, resolving the first Depakote birth defect lawsuit filed against pharmaceutical giant Abbott Laboratories settled in front of a jury. The plaintiffs in the case of alleged that the epilepsy medicine was a direct cause of the child’s birth defects.
Lawsuit documents reveal that the family was making allegations that Abbott Laboratories had design Depakote with obvious defects and then concealed the potential risk of harm from doctors, patients, and the public. Jury members agreed with the family that Abbott Laboratories should be held financially responsible and awarded the child and family $15 million in compensatory damages. An additional $23 million was awarded to the family for punitive damages. The jury believed the family deserved punitive damages because the child suffers from spina bifida because the mother was never made aware of the potentially serious side effects of taking Depakote during her pregnancy.
- Abbott Laboratories Loses Summary Judgment to Stop Depakote Pregnancy Birth Defect Lawsuit
March 2015 – A Depakote birth defect lawsuit filed against the anti-seizure medication manufacturer Abbott Laboratories will be moving forward in federal court. The judge ruled on a summary judgment that the 1994 black box warnings on Depakote labels did not provide adequate information about the potential risks of taking the medication.
Lawsuit documents reveal that the plaintiff suffered from serious spinal cord defects and other physical and cognitive injuries in December 1994. His mother had been using the drug maker’s anti-epilepsy medication Depakote that was first prescribed to her in 1989 that was before, during and after pregnancy. The lawsuit indicates that the plaintiff contends the drug maker had a duty to provide accurate and complete information of all known side effects and adverse reactions on the labeling statements posted on the product in 1994.
Many Depakote pregnancy birth defect lawsuits have been filed against Abbott Laboratories in recent years. Most plaintiffs are claiming that the drug maker is financially responsible for the birth defects their medical product causes. These lawsuits have been filed in state and federal courts. In 2012, Abbott Laboratories was forced to pay over $1 billion because of the deceptive actions and illegal marketing of Depakote.
Are You Ready to File Your Depakote Lawsuit?
If you have been wondering whether it is important to speak with lawyers to discuss your case, the answer is a resounding yes. The Depakote injury attorneys at the Drug Law Center are experienced in successfully resolving product liability medical malpractice cases involving birth defects and severe injuries. Our law firm builds solid cases for monetary recompense by arguing to the court and the defendant’s attorneys that the drug maker failed to warn patients, healthcare providers and the public of the potential risks of using their medication.
If you, or a loved one, were injured by taking Depakote boards generic for divalproex sodium, it is essential to speak with one of our attorneys right now. Contact us today so we can begin the process of obtaining financial recompense on your behalf by scheduling a comprehensive case evaluation at no charge. We are currently accepting Depakote compensation claims through contingency fee agreements to avoid making any upfront payment.