Drug Information for VALPROIC ACID SYRUP (Valproic Acid Oral Solution, USP) 250 mg/5 mL (Morton Grove Pharmaceuticals, Inc.): Patient Information Leaflet

  • Important Information for Women Who Could Become Pregnant About the Use of Valproic Acid Syrup (Valproic Acid Oral Solution, USP).

    Please read this leaflet carefully before you take any of this medication. This leaflet provides a summary of important information about taking this medication to women who could become pregnant. If you have any questions or concerns, or want more information about this medication, contact your doctor or pharmacist.

    Information For Women Who Could Become Pregnant

    This medication can be obtained only by prescription from your doctor. The decision to use this medication is one that you and your doctor should make together, taking into account your individual needs and medical condition.

    Before using this medication, women who can become pregnant should consider the fact that this medication has been associated with birth defects, in particular, with spina bifida and other defects related to failure of the spinal canal to close normally. Approximately 1 to 2% of children born to women with epilepsy taking valproic acid in the first 12 weeks of pregnancy had these defects (based on data from the Centers for Disease Control, a U.S. agency based in Atlanta). The incidence in the general population is 0.1 to 0.2%.

    This medication has also been associated with other birth defects such as defects of the heart, the bones, and other parts of the body. Information suggests that birth defects may be more likely to occur with this medication than some other drugs that treat your medical condition.

      Information For Women Who Are Planning to Get Pregnant
    • Women taking this medication who are planning to get pregnant should discuss the treatment options with their doctor.
      Information For Women Who Become Pregnant
    • If you become pregnant while taking this medication you should contact your doctor immediately.
      Other Important Information
    • Your medication should be taken exactly as prescribed by your doctor to get the most benefit from your medication and reduce the risk of side effects.
    • If you have taken more than the prescribed dose of your medication, contact your hospital emergency room or local poison center immediately.
    • Your medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

    Facts About Birth Defects

    It is important to know that birth defects may occur even in children of individuals not taking any medications or without any additional risk factors.

    This summary provides important information about the use of valproic acid to women who could become pregnant. If you would like more information about the other potential risks and benefits of this medication, ask your doctor or pharmacist to let you read the professional labeling and then discuss it with them. If you have any questions or concerns about taking this medication, you should discuss them with your doctor.

  • Drug Information Provided by National Library of Medicine (NLM).