FDA approves a new once-daily pill for treating manic episodes in bipolar disorder.

The U.S. Food and Drug Administration (FDA) has approved a new, extended-release version of a medicine called Depakote ER. This pill is approved for the acute, or short-term, treatment of manic or mixed episodes in adults with bipolar I disorder. These episodes are distinct periods of abnormally high, expansive, or irritable mood that can be severe. The approval is based on studies showing it can help manage these symptoms. This approval provides a new once-daily oral option for doctors and patients to consider when managing acute mania. It is important to know that the studies supporting its use for this purpose lasted about three weeks. The drug's label states that its effectiveness for long-term use in preventing future manic episodes (more than three weeks) has not been proven in controlled clinical trials. As with any medication, this one has important safety information. The drug carries a serious warning about the risk of birth defects and is not for use in pregnant women or women who could become pregnant and are not using birth control. The most important step for anyone considering this or any new treatment is to have a detailed conversation with their doctor. A doctor can review your full medical history, discuss all potential benefits and risks, and determine if this treatment option is appropriate for your individual care plan.