The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium), the agency announced Tuesday. Depakote is approved for the treatment of seizures, bipolar disorder and migraine headaches.
People with bipolar disorder have reported that they feel intense bursts of energy, joy, or constantly feel edgy (irritability). These mood swings are much more extreme than the normal ups and downs experienced by most people and they can last for days, weeks, or months. People who suffer from bipolar disorder experience a combination of symptoms of mania and depression. They can experience psychotic symptoms during an episode of mania or depression. These symptoms include: hallucinations (hearing or seeing things that are not actually there) and delusions (false beliefs not influenced by logical reasoning).
An epileptic seizure can manifest as an alteration in mental state, tonic or clonic movements, convulsions, and various other psychic symptoms. Seizures can occur in people who do not have epilepsy. A seizure can last from a few seconds to status epilepticus, which is a continuous seizure that will not stop without intervention.
Sun Pharmaceutical Industries Ltd., Mumbai, India; Genpharm Inc., Ontario, Canada; Nu-Pharm Inc., Ontario, Canada; Upsher-Smith Laboratories, Maple Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy’s Laboratories, Hyderabad, India; and Lupin Limited, Mumbai, India, have received approval to produce generic versions of the brand-name drug made by Abbott Laboratories.
“Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product,” Gary Buehler, director of the FDA’s Office of Generic Drugs, said in a news release.
The generics will have the same label warnings as the brand-name medication. The most severe side effects of Depakote are irreversible birth defects, such as births of brainless babies. Some if its side effects may not require medical attention. 1% to 10% of people report weight gain and increased appetite. Dangerous side effects include vomiting, loss of appetite, fever, or dark urine. The Boxed Warning will also include cautions about increased risk of severe liver damage and inflamed pancreas. Elevated ammonia levels have been reported in some patients receiving valproate.
The most common side effects reported in clinical trials for mania with Depakote ER were drowsiness, stomach upset following meals, nausea, vomiting, diarrhea, dizziness, and abdominal pain, according to Depakote ER official Web site.
Doctor must check their patients’ liver function before they start this medication and at frequent intervals thereafter. Patients will also be monitored for symptoms that lead to liver toxicity.
Before taking Depakote, women who could become pregnant should talk to their doctor, as valproic acid has been associated with birth defects in children of women who have taken the medicine while they were pregnant.
People taking Depakote or Depakote ER may experience low blood platelet counts, drowsiness when they start this medication.
