FDA warns about risk of Depakote
Depakote or dilvalproex sodium is used to treat seizure disorders. It consists of valproate and valproic acid. It cures patients by affecting chemicals causing seizure in human body. It is also used with other medicines for the treatment. It is used to cure epilepsy; mania or bipolar disorder and migraine headache attacks.
It comes under different brand names as follows
- Depacon (valproate sodium)
- Depakote, Depakote CP, Depakote ER (dilvalproex sodium)
- Depakene (valproic acid)
- Stavzor (valproic acid)
There have been several reports of this drug causing liver problems such as pancreatitis or inflamed liver. Infant deaths and fatal harm to fetus have also been evident. It is said to be the cause of neural tube defects in babies if taken during pregnancy. There have been evidences that pregnant women taking this drug delivered children with major birth defects. These defects include brain defect, spinal cord defect, abnormal face formation and cardiovascular malformation in the babies.
All these incidents lead to a notification from FDA to healthcare practitioners and patients as well. FDA has notified them about high risk of birth defects from use of valproate sodium or Depakote. The major producer or manufacturer of valproate sodium drug is Abbot Laboratories, who produces it under the name of Depakote. It is used for treatment of manic or bipolar disorder, epilepsy, or migraine attacks.
Depakote is being used for a long time after it was approved FDA, in 1983 for the treatment of epilepsy. Treatment of manic or bipolar disorder by Depakote was approved by FDA in May of 1995. Later in 1996 it was also approved for treating migraine. In December 2002 Depakote ER got approval from FDA for treatment of seizure disorders combined with other medicines. It got approval for treatment of various disorders in many phases.
FDA has categorized Depakote in pregnancy category D. It has warned pregnant women and henceforth lead these guidelines for use of Depakote.
- Women, who are planning to have a baby or got pregnant during use of Depakote, should consult their doctor.
- Use of valproate should not be stopped suddenly. It is advisable to consult a doctor first. It is same in the case of pregnancy too.
- Women in their childbearing age should not use valproate unnecessarily. Use of it should be limited to emergency or high need. Consulting a doctor before taking this drug is advisable.
- It is better to avoid pregnancy while using valproate.
- It also advised pregnant women having Depakote for treatment of epilepsy to register in the North American Antiepileptic Drug Pregnancy Registry. It will help them to know risks involved with drug and manage it in a better way.
The medication guide is provided with each prescription, which give details of the benefits and risks of using valproate. Patients should talk to their doctor about its risk and benefits before using this drug. They should also consult their doctor if they feel anything unusual or have allergic or liver related problems.