BOX WARNING
HEPATOTOXICITY
HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID AND ITS DERIVATIVES. 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 DEPACON IS USED IN THIS PATIENT GROUP, IT 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.
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.)
| | |
NEWS HIGHLIGHTSMedia Articles Related to Depacon (Valproate)
Valproate Migraine Drugs During Pregnancy Bad For Baby's IQ
Source: Headache / Migraine News From Medical News Today [2013.05.07]
Using migraine prevention valproate sodium drugs during pregnancy can cause offspring to have a lower IQ, the US Food and Drug Administration (FDA) warned yesterday. Sodium valproate is an anticonvulsant prescribed by doctors for the treatment of migraine, bipolar disorder, PTSD (post-traumatic stress disorder), anxiety disorder, anorexia nervosa and epilepsy...
Taking Valproate While Pregnant Raises Autism Risk
Source: Autism News From Medical News Today [2013.04.24]
Researchers have found that pregnant women who take the drug valproate (for epilepsy) could be at an increased risk of giving birth to a child with autism, according to a new study published in the journal JAMA...
Use Of Anti-Epileptic Drug During Pregnancy Associated With Increased Risk Of Autism
Source: Autism News From Medical News Today [2013.04.26]
Maternal use of valproate (a drug used for the treatment of epilepsy and other neuropsychological disorders) during pregnancy was associated with a significantly increased risk of autism in offspring, according to a study in the April 24 issue of JAMA. The authors caution that these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control...
Published Studies Related to Depacon (Valproate)
Assessment of cognitive impairments and seizure characteristics in
electroconvulsive therapy with and without sodium valproate in manic patients. [2013]
characteristics in patients with and without concurrent sodium valproate therapy... CONCLUSIONS: Continuing the administration of sodium valproate neither adversely
Comparing efficacy of ECT with and without concurrent sodium valproate therapy in
manic patients. [2012]
therapy... CONCLUSIONS: The pattern of results from this double-blind randomized clinical
A comparative study of the effects of low-dose topiramate versus sodium valproate
in migraine prophylaxis. [2012]
The present study was performed to evaluate the efficacy of low-dose topiramate
and compare it with sodium valproate that is prevalently prescribed as a migraine
prophylaxis. This was a randomized, double-blind, parallel-group clinical trial
on 56 patients who completed the course of study... Topiramate dose of 50
mg/day with fewer side effects in comparison with its higher doses may be an
appropriate substitution for first-line migraine prophylaxis such as valproate.
Valproate versus diazepam for generalized convulsive status epilepticus: a pilot study. [2011.12]
Background and purpose: Evidence-based data to guide the management of status epilepticus (SE) after failure of primary treatment are still scarce and the alternate needs to be found when phenytoin (PHT) is not available or contraindicated. Comparison of intravenous (IV) valproate (VPA) and diazepam (DZP) infusion has not been conducted in adults with SE...
Treatment of suicide attempters with bipolar disorder: a randomized clinical trial comparing lithium and valproate in the prevention of suicidal behavior. [2011.10]
CONCLUSIONS: Despite the high frequency of suicide events during the study, this randomized controlled trial detected no difference between lithium and valproate in time to suicide attempt or suicide event in a sample of suicide attempters with bipolar disorder. However, smaller clinically significant differences between the two drugs were not ruled out.
Clinical Trials Related to Depacon (Valproate)
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.
Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases [Recruiting]
Primary Objective:
- Determine the interindividual range and median of individual maximum tolerated doses of
valproic acid administered as one time evening dose in conjunction with a dose oral
etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for
four different age groups.
Secondary Objectives:
- Determine the qualitative and quantitative toxicity and reversibility of toxicity of
valproic acid in conjunction with oral etoposide,
- To investigate the clinical pharmacokinetics of valproic acid when given in conjunction
with oral etoposide,
- To describe quality of life of patients with relapsed, or progressive central and
peripheral nervous system tumors when treated with oral valproic acid and etoposide,
- To observe and describe the response pattern of progressive central nervous system
tumors treated with oral valproic acid and etoposide,
- To observe and describe event free survival time and overall survival time of patients
with relapsed, or progressive central nervous system tumors when treated with oral
valproic acid and etoposide,
- To determine if histone deacetylase activity and topoisomerase expression in
lymphocytes of patients is related to valproic acid levels, and
- To determine, if the individual maximal tolerated dose (iMTD) depends on the initial
performance status of the patient in the beginning of the treatment.
Effectiveness of Divalproex Sodium (Depakote) in Treating Disruptive Behavior Disorder and Explosive Tempers in Adolescents and Adults [Recruiting]
|
