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The Depakote Drug Lawsuit

Depakote® (divalproex sodium) is a prescription drug used to treat a variety of conditions, including acute manic episodes associated with bipolar disorder, complex partial seizures in adults and children 10 years of age and older, simple and complex absence seizures, with or without other seizure types, and migraine headaches.

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What is Depakote?

First sold in 1983 for epilepsy treatment, Depakote is the brand name for sodium divalproex, a compound made of sodium valproate and valproic acid. Depakote was approved for treatment of bipolar disorder in 1995 and migraine headaches in 1996. Manufactured by Abbott Laboratories, the drug can be ingested in a variety of ways including pill, injection, or liquid form. Regardless of the method ingested, Depakote is used to treat certain medical conditions by increasing the GABA (a neurotransmitter) in the brain and helping to reduce voltage sensitive sodium channels.Depakote has been linked to several serious side-effects including pancreatitis, liver toxicity, suicide, and birth defects (cardiovascular malformations, neural tube defects and facial deformities).

What is Depakote used for?

Currently Depakote is only approved to combat and control epileptic seizures, bipolar mania, and the prevention of migraines. Although Abbott Laboratories has conducted clinical trials to use Depakote to treat dementia, these trials were suspended when patients experienced negative side-effects including anorexia, somnolence, and dehydration. From 1998 to 2006 the company illegally marketed the use of Depakote for the control of agitation and aggression in elderly dementia patients. From 2001 to 2006 Abbott Laboratories illegally marketed Depakote for the treatment of schizophrenia. Neither actions were approved by the Federal Drug Administration. In 2012 Global Health Care Company Abbott Laboratories Inc. pled guilty to criminal and civil charges for promoting Depakote for unauthorized purposes and agreed to pay an estimated $1.5 billion in fines and penalties. This payout is the second largest payout to date by a drug company. The Attorney General for the case stated that this move was an effort to “stop this type of activity…and send a strong message to other companies.”

  • Although the manufacturer Abbot Laboratories has illegally marketed Depakote for treatment of schizophrenia and aggression and agitation in elderly patients, Depakote has not been approved for these conditions. Currently, Depakote has only been approved to treat the following conditions:
  • Epileptic seizures
  • Bipolar mania
  • Prevention of migraines

Depakote Usage and Statistics

Antiepileptic therapies which treat patients with epilepsy is big business in the United States. In fact, experts estimate that more than 2.5 million people may suffer from some type of seizure disorder, which generates billions of dollars in healthcare costs. In fact, prescription medications for the treatment of epilepsy are estimated at more than $10 billion dollars per year. Depakote has made billions of dollars for Abbott Laboratories since its market release. Abbot Laboratories, however, is just one of the major players in the market. Other manufacturers of popular Antiepileptic medications include Johnson & Johnson, Pfizer, Cephalon, and GlaxoSmithKline. Sales have declined substantially with the introduction of generic competition in 2008, which drove down the price for antiepileptics. Another issue which damaged the sale of the product was the criminal charges against Abbott Laboratories for the promotion of Depakote for the off-label treatment for certain conditions.

How Depakote Works

Depakote has helped millions of patients suffering from epilepsy, migraines, and bipolar disorder. Medical experts are not exactly sure how the drug works, but they know that it blocks sodium channels in neurons, which can lower neuron activity. Experts also claim it “augments the activity of a GABA-synthesizing protein, GAD, and restrict a GABA-degrading protein, GABA-T.” The result is overactive neurons seem to calm.

Side Effects of Depakote

  • Not only are doctors concerned about the side-effects of taking Depakote, especially women who are pregnant or who are considering becoming pregnant. Common side-effects include:
  • Headache
  • Dizziness
  • Tremors
  • Nausea
  • Vomiting
  • Diarrhea
  • Sick feeling in the stomach
  • Hair loss
  • Vision problems
  • Double vision
  • Coordination issues
  • Weakness
  • Weight gain
  • Loss of Appetite
  • Stomach pain
  • Drowsiness
  • Fatigue
  • Asthenia
  • Indigestion
  • Stomach cramps
  • Liver Irritation
  • Pancreatic issues
  • Flu Syndrome
  • Slurred speech
  • Respiratory infection
  • Ringing or buzzing in the ears
  • Sedation
  • Abdominal pain
  • Rash
  • Hallucinations
  • psychosis

Depakote Medical Studies

No one knows for sure how many millions of Americans suffer with epilepsy and bipolar disorder, but treatment for these conditions is critical to ensure patients live a prosperous and fulfilling life. Unfortunately, with most types of medications there are risks associated with use. In clinical trials subjects who used Depakote showed significant improvement in the reduction of the frequency of their seizures. According to the study, “seizure frequency was calculated to reflect the median number of seizures during an eight-week measurement period versus an eight-week treatment period with Depakote.” Subjects did experience certain common side-effects from Depakote. The most common side-effects included vomiting, abdominal pain, anorexia, and tremors.

Depakote Black Box Warnings

  • Depakote should not be used by pregnant or nursing mothers, especially in the first trimester where it is linked to birth defects. Do not stop taking the medication suddenly because it can also cause physical and psychological withdrawal symptoms. Do not operate machinery or drive while on the medication because it is known to cause drowsiness, dizziness, or blurred vision. This medication is not recommended for young children. Do not take Depakote if you have any of the following conditions:
  • Liver disease
  • Unusual reaction to divalproex sodium, other medicines, foods, dyes, or preservatives
  • Brain damage
  • Kidney disease
  • Low blood proteins
  • Blood disease

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