FDA Warnings For Depakote
Depakote is a commonly marketed name for valproic acid. This acidic chemical compound is used as a mood stabilizing and anticonvulsant drug, which treats bipolar disorder, epilepsy, depression, migraines, and schizophrenia.
The drug was first synthesized in 1882 as an analogue of valeric acid, which is naturally found in valerian. The drug was approved as an antiepileptic drug in 1967 in France and since has become one of the most prescribed antiepileptic drugs on the market worldwide. It would later become a popular prescribed drug for migraines and bipolar disorders.
If you or a family member has suffered any severe side effects, which resulted in an injury, due to taking Depakote, our defective drug attorneys believe that the victim may be entitled to compensation for any losses and damages including; lost wages, pain and suffering, and medical expenses.
Depakote FDA Warnings
A report performed by the Massachusetts General Hospital revealed that women who took Depakote increased their risk of delivering a child with birth defects by up to four times compared to women taking other similar drugs. In addition, there has been several other possible side effects have been listed in the FDA warnings.
Some Depakote FDA Warnings include:
Hepatotoxicity
The liver serves an important role in cleaning chemicals from the body, thus when certain drugs are taken in excess they can cause injuries to the liver. In addition, children under two years old are put at an increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants.
Fetal Risk
Depakote has been linked to the cause of congenital malformations, especially neural tube defects. Thus, these drugs should not be taken by a woman of childbearing potential.
Pancreatitis
Extreme cases of pancreatitis have been reported in children and adults who have been taking Depakote. In some instances, these cases were reported as hemorrhagic while rapidly progressing to death. This usually begins with abdominal pain, vomiting, nausea, or anorexia like symptoms.
Urea Cycle Disorders
Depakote can be used in patients with urea cycle disorders, while it should not be taken if patients have a history of encephalopathy or coma, unexplained mental retardation, history of elevated plasma ammonia, or glutamine, or a history of family UCD or unexplained infant deaths.
Suicidal Behavior
Depakote is known to increase the risk of suicidal behaviors, thus patients should be monitored for any signs of increased depression, suicidal thoughts, or changes in mood. Overall, there have been a total of four suicides while patients were on the drug.
Thrombocytopenia
This is caused due to the drug inhibition the secondary phase of blood platelet aggregation, which causes abnormal platelet counts and abnormal coagulation. It has been proven to cause hemorrhaging, bruising, when the dosage is decreased or during withdrawal from therapy.
Hyperammonemia
Hyperamonemia is when the ammonia levels in the body are increased. Cases have been indicated during valproate therapy sessions and may be present even though one may have normal liver tests. If any unexplained vomiting or changes in mental status occur, the patient should be tested for high ammonia levels.
Hypothermia
Hypothermia is defined as the unintentional drop in your bodies core temperature. This has been reported in Depakote users which have increased their daily doses. Patients who are experiencing symptoms of hypothermia should stop taking the drug and have their blood ammonia levels tested.
Hypersensitivity Reactions of Organs
Although rather uncommon, there have been reports of hypersensitivity reactions of organs, which result in hospitalizations along with one death. Patients with these sorts of reactions may experience a rash and a fever. Patients may also experience asthenia, hepato-renal syndrome, arthralgia, pruritus, oliguria, nephritis, hematological abnormalities, hepatitis, liver test abnormalities, and lymphadenopathy.
There may be additional FDA warnings, however these are the most common warnings found for the drug Depakote. If you have experienced any of these symptoms, it is advised to seek immediate medical attention to avoid further injury or death. These medical documents can also be used by a
personal injury lawyer Cincinnati, Ohio to develop a strong case against the negligent individual or entity whom caused the injury.
