Depakote (divalproex sodium) is an anticonvulsant drug manufactured and sold by Abbott Laboratories. It is used for the treatment of epilepsy in adults and children ages 10 and older. It can also be used in the treatment of depression, migraines, headaches, and bipolar disorders.
Depakote Birth Defects Revealed in Studies
Aside from controversies involving the recommendation of Depakote for off-label purposes that led to a lawsuit, the manufacturer faces more issues as the drug has been linked with several serious side effects. Recent scientific studies have shown that the use of this drug during pregnancy may result in disfiguring birth defects in infants. A study published in the New England Journal of Medicine showed that Depakote could cause birth defects such as cleft palate, neural tube defects, spina bifida, cognitive impairments, abnormal skull formation, malformed limbs, extra fingers and toes, and defects to parts of the heart. These Depakote side effects during pregnancy become more severe if a woman takes the medication during the first month, or first trimester, of her pregnancy.
Other Widely-Known Depakote Side Effects
In addition to this, the FDA has also required the manufacturer to include a warning that specifies that Depakote has been known to increase suicidal tendencies in some patients. The drug may also cause certain serious liver problems and pancreatitis. Pancreatitis is a serious inflammation of the pancreas, where the patient can exhibit certain symptoms such as stomach pain, nausea, vomiting, or loss of appetite. In some instances, it is also reported to have caused a low blood platelet count.
Depakote Manufacturer Expected to Meet Certain Drug Safety Guidelines
Abbott Laboratories is bound to perform the necessary studies and trials in order to ensure that their drugs are safe. Potential risks associated with a particular drug also have to be fully disclosed in the labels and reported accordingly to the Food and Drug Administration. Absent the required standard of due care, any manufacturer may be held liable for their defective/dangerous drugs.
Depakote and FDA Warnings
All of the data and information gathered on the dangers of Depakote recently led the FDA to take additional action. In December 2009, the FDA issued a statement warning physicians and patients about the very serious birth defects associated with the use of Depakote during pregnancy. In an effort to assist patients in weighing these risks, the FDA now requires that a medication guide be provided with the antiepileptic drug. This guide warns patients of the many side effects, including birth defects that may occur with the use of Depakote.
PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING USE OF DEPAKOTE OR ANY OTHER PRESCRIPTION MEDICATION.
Have You or a Loved One Given Birth to a Child with Birth Defects After Taking Depakote?
If you or a loved one have given birth to a child with birth defects after taking Depakote, you may want to speak with a personal injury attorney regarding a potential Depakote lawsuit. d’Oliveira & Associates, Rhode Island personal injury lawyers, are working with some of the leading lawyers in the country who are handling these cases.
Please contact the law offices of d’Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.d’Oliveira & Associates
Providence, RI 02909
Phone: (401) 831-8600