BOX WARNING
HEPATOTOXICITY
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID. EXPERIENCE HAS INDICATED THAT CHILDREN UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED RISK OF DEVELOPING FATAL HEPATOTOXICITY, ESPECIALLY THOSE ON MULTIPLE ANTICONVULSANTS, THOSE WITH CONGENITAL METABOLIC DISORDERS, THOSE WITH SEVERE SEIZURE DISORDERS ACCOMPANIED BY MENTAL RETARDATION, AND THOSE WITH ORGANIC BRAIN DISEASE. WHEN DEPAKENE PRODUCTS ARE USED IN THIS PATIENT GROUP, THEY SHOULD BE USED WITH EXTREME CAUTION AND AS A SOLE AGENT. THE BENEFITS OF THERAPY SHOULD BE WEIGHED AGAINST THE RISKS. ABOVE THIS AGE GROUP, EXPERIENCE IN EPILEPSY HAS INDICATED THAT THE INCIDENCE OF FATAL HEPATOTOXICITY DECREASES CONSIDERABLY IN PROGRESSIVELY OLDER PATIENT GROUPS.
THESE INCIDENTS USUALLY HAVE OCCURRED DURING THE FIRST SIX MONTHS OF TREATMENT. SERIOUS OR FATAL HEPATOTOXICITY MAY BE PRECEDED BY NON-SPECIFIC SYMPTOMS SUCH AS MALAISE, WEAKNESS, LETHARGY, FACIAL EDEMA, ANOREXIA, AND VOMITING. IN PATIENTS WITH EPILEPSY, A LOSS OF SEIZURE CONTROL MAY ALSO OCCUR. PATIENTS SHOULD BE MONITORED CLOSELY FOR APPEARANCE OF THESE SYMPTOMS. LIVER FUNCTION TESTS SHOULD BE PERFORMED PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER, ESPECIALLY DURING THE FIRST SIX MONTHS.
TERATOGENICITY
VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF VALPROATE PRODUCTS IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS. THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY REVERSIBLE CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT INJURY OR RISK OF DEATH (E.G., MIGRAINE) IS CONTEMPLATED. SEE WARNINGS, INFORMATION FOR PATIENTS.
A PATIENT INFORMATION LEAFLET DESCRIBING THE TERATOGENIC POTENTIAL OF VALPROATE IS AVAILABLE FOR PATIENTS.
PANCREATITIS
CASES OF LIFE-THREATENING PANCREATITIS HAVE BEEN REPORTED IN BOTH CHILDREN AND ADULTS RECEIVING VALPROATE. SOME OF THE CASES HAVE BEEN DESCRIBED AS HEMORRHAGIC WITH A RAPID PROGRESSION FROM INITIAL SYMPTOMS TO DEATH. CASES HAVE BEEN REPORTED SHORTLY AFTER INITIAL USE AS WELL AS AFTER SEVERAL YEARS OF USE. PATIENTS AND GUARDIANS SHOULD BE WARNED THAT ABDOMINAL PAIN, NAUSEA, VOMITING, AND/OR ANOREXIA CAN BE SYMPTOMS OF PANCREATITIS THAT REQUIRE PROMPT MEDICAL EVALUATION. IF PANCREATITIS IS DIAGNOSED, VALPROATE SHOULD ORDINARILY BE DISCONTINUED. ALTERNATIVE TREATMENT FOR THE UNDERLYING MEDICAL CONDITION SHOULD BE INITIATED AS CLINICALLY INDICATED. (See WARNINGS and PRECAUTIONS.)
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DEPAKENE SUMMARY
DEPAKENE (valproic acid) is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid.
DEPAKENE (valproic acid) is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. DEPAKENE (valproic acid) is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
SEE WARNINGS FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.
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NEWS HIGHLIGHTSMedia Articles Related to Depakene (Valproic Acid)
Is Hepatic Differentiation Of Embryonic Stem Cells Induced By Valproic Acid And Cytokines?
Source: Health News from Medical News Today [2009.11.19]
Embryonic stem (ES) cells, known for their capacity to proliferate indefinitely and differentiate into almost all types of cells including hepatocytes, have raised the hope of cellular replacement therapy for liver failure.
Published Studies Related to Depakene (Valproic Acid)
Effect of valproic acid on body weight, food intake, physical activity and hormones: results of a randomized controlled trial. [2009.09]
The objective of this study was to identify mechanisms through which valproic acid (VPA) causes weight gain. Healthy participants (N = 52) were randomized to VPA or placebo in a double-blind study... Research testing VPA on short-term (1 week) EI, metabolism, and substrate partitioning is warranted.
Randomized sequential trial of valproic acid in amyotrophic lateral sclerosis. [2009.08]
OBJECTIVE: To determine whether valproic acid (VPA), a histone deacetylase inhibitor that showed antioxidative and antiapoptotic properties and reduced glutamate toxicity in preclinical studies, is safe and effective in amyotrophic lateral sclerosis (ALS) using a sequential trial design... INTERPRETATION: Our finding that VPA, at a dose used in epilepsy, does not show a beneficial effect on survival or disease progression in patients with ALS has implications for future trials with histone deacetylase inhibitors in ALS and other neurodegenerative diseases. The use of a sequential trial design allowed inclusion of only half the number of patients required for a classic trial design and prevented patients from unnecessarily continuing potentially harmful study medication.
Effects of valproic acid on sleep in children with epilepsy. [2009.08]
PURPOSE: Parents frequently report increased sleep duration in their children during treatment with valproic acid (VPA).The change was small in the majority, but considerable in a subgroup of children.
Lamotrigine and valproic acid have different effects on motorcortical neuronal excitability. [2009.04]
To investigate different cortical effects of lamotrigine and valproic acid, 30 paid healthy adult men were given, in a randomized/blinded fashion on three separate days (separated by a week), either a single dose of lamotrigine 325 mg, or a single dose of valproic acid 1,250 mg, or placebo...
Effect of valproic acid on body weight, food intake, physical activity and hormones: results of a randomized controlled trial. [2008.06.26]
Abstract The objective of this study was to identify mechanisms through which valproic acid (VPA) causes weight gain. Healthy participants (N = 52) were randomized to VPA or placebo in a double-blind study... Research testing VPA on short-term (1 week) EI, metabolism, and substrate partitioning is warranted.
Clinical Trials Related to Depakene (Valproic Acid)
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy [Completed]
To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets
to Depakote ER tablets in the pediatric population.
Valproate in Late Life Schizophrenia [Completed]
The purpose of this research study is to analyze the effectiveness and tolerability of a
medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who
have schizophrenia.
An Open Label, Double Blind Study Using Consecutive Intravenous Depacon With Oral Depakote ER for the Treatment of Cluster Headaches. [Completed]
The purpose of this study is to collect and evaluate information on the use of Depakote
Extended Release (ER) and Depacon Intravenous (IV) in patients with cluster headaches.
Patients who are currently in a cluster cycle will be treated with 2 consecutive days of IV
Depacon followed by oral Depakote ER. Patients will receive a total of 1,000mg of Depacon
and 1,000mg of Depakote ER each day. Patients may have a 3rd day of IV Depacon followed by
oral Depakote ER if the primary investigator believes it to be beneficial. The patient is
then sent home on oral Depakote ER. The dose of Depakote ER can range from 500mg to 2,000mg
this dose is to be determined by the primary investigator. The patient will continue the
oral Depakote ER until the end of their cluster cycle or for a maximum of 6 weeks, which ever
comes first.
A Comparison Study of the Efficacy and Tolerability of Depakote ER and Depakote DR [Completed]
To compare the time to response, response rates, remission rates, and side effects in Bipolar
Disorder inpatients treated with Depakote ER or Depakote DR for acute mania or mixed mania.
Effects of Divalproex Sodium on Food Intake, Energy Expenditure, and Posture Allocation [Completed]
The purpose of the proposed study is to identify the mechanisms responsible for the weight
gain associated with Depakote treatment, and to identify methods to prevent and treat weight
gain in people taking Depakote. Both sides of the energy balance equation will be measured in
a sample of healthy lean and overweight adults. Energy intake will be measured in the
Pennington Center's Eating Laboratory, and total daily energy expenditure (TEE) and posture
allocation will be measured with the IDEEA™. Questionnaires that assess food cravings and
eating attitudes and behaviors will be used to determine if a behavioral phenotype is
associated with weight gain in response to Depakote treatment. It is hypothesized that
Depakote treatment will result in increased food intake. It is also hypothesized that the
time spent engaging in sedentary behavior will increase in response to Depakote treatment.
Time spent engaging in, and the energy expended during, physical activity is expected to
decrease significantly. Therefore, it is hypothesized that TEE is expected to decrease
significantly. The results will be used to identify specific behavioral targets to prevent
weight gain during treatment with Depakote. Potential targets include interventions to modify
food intake and physical activity. The degree to which each behavior (food intake or physical
activity) will be targeted is dependent on the results of this study. For instance, if the
majority of the weight gain associated with Depakote treatment is due to changes in food
intake, stronger dietary interventions will be suggested. Additionally, changes in endocrine
factors (hormones and peptides) will be evaluated during the study to determine if Depakote
is associated with an altered endocrine response that affects satiety, food intake, or energy
expenditure. If an altered endocrine response is found, these results will be used to
identify adjunctive medications or compounds to correct the endocrine response and reduce
weight gain. Genomic studies will also be possible, since gene sequencing and gene expression
can be analyzed from archived buffy coat samples.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Depakene has an overall score of 5. The effectiveness score is 6 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst.
| | Depakene review by care giver of 14 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Tonic clonic seizures |
| Dosage & duration: | | 500mg PM 375 mg AM taken twice a day for the period of 12 years |
| Other conditions: | | autism, developmental delay |
| Other drugs taken: | | clonazepam, nitrazepam | | |
Reported Results |
| Benefits: | | Moderate seizure control, seizures controlled during the awake hours, however, still uncontrolled during sleep. Patient has multiple, short seizures, nightly.
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| Side effects: | | Side effects were at first loss of appetite, then later, increased appetite. Also some irritability which we cannot be sure but may be related to the drug. However, it could be due to the nighttime seizures which are still occurring. |
| Comments: | | Take 500 mg of Valproic Acid before bed, daily, and 375 mg at breakfast, daily. This dose was titrated up slowly and eventually stopped at this level. Blood work is done to check the blood trough level. We are instructed to contact the physician should the seizure pattern change. |
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| | Depakene review by 25 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar Disorder |
| Dosage & duration: | | 500 mg taken two times per day for the period of 5 months |
| Other conditions: | | Post Traumatic Stress |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Initial benefits were comparable to the brand name version of this drug, Depakote. I had been taking Depakote for several months and experienced great results. When I went to my psychiatrist for an evaluation and re-fill, he accidently prescribed the generic version, Depakene. When I discovered the error, I was told by this doctor that I would experience the same results as Depakote. The positive side effects of the Depakene: balanced mood, improved concentration, improved logical cognition, mental clarity, lessened anxiety and irritability, improved sleep, increase in pleasure about activities |
| Side effects: | | Depakene has a very thin coating, which caused severe heart burn and stomach upset. The discomfort was so unpleasant that it made me not want to take my meds, so I was not taking them consistently as prescribed. This caused my mood to fluctuate again. Even after I switched to the Depakote, my stomach was still uncomfortable for several weeks afterwards. My appetite decreased and food was very unappetizing. Certain foods that I normally enjoy, such as chicken or fish, made me feel extremely queasy when I ate them. I did not like the physical side effect of the drug, and decided to quit my psychiatric drugs altogether - because I was no longer stable anymore! |
| Comments: | | Depakote was prescribed to me by a Kaiser psychiatrist in Pleasant Hill, CA in 2006. The medication was given to help treat the diagnosis of Bipolar Disorder, Type II. My disease was misdiagnosed for several years as depression, since I was never seen by a professional during hypomanic episodes, and when I did see a professional, I did not think that my manic symptoms were signs of a serious psychiatric problem. Anti-depressant drugs were prescribed: Prozac in 2001, which had minimal effect and I stopped taking them a few months later. Wellbutrin was prescribed again for "chronic depression" in the spring of 2006, but this medication slowly spun me into an intense manic period. After the manic episode, I fell very hard into a severe, suicidal depressive state. I was voluntarily admitted to a psychiatric ward in June 2006 to keep me safe and to properly diagnose my condition. The symptoms I was experiencing before being prescribed the Depakote/Depakene: rapidly cycling mood swings between intense activation and irritablity/excitement and crashing lows and depression, suicidal thoughts, poor logic and decision making, racing thoughts, anxiety, poor concentration, and poor sleep. |
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Page last updated: 2009-11-19
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