New Drug for Long-Term Bipolar Treatment
Zyprexa Now Approved to Delay Mania, Depression Relapse
Jan. 15, 2004 -- The FDA has approved Zyprexa to treat bipolar disorder over the long-term.
The FDA had previously approved Zyprexa to treat acute episodes of mania associated with bipolar disorder. Now the drug is approved to delay relapse into either mania or depression in patients with bipolar disorder.
"Bipolar disorder is a serious condition that can be difficult to treat. For those who achieve stability on existing medications, relapse of symptoms is all too common," says Frederick K. Goodwin, MD, director, Center on Neuroscience, Medical Progress, and Society, at the George Washington University Medical Center, Washington, D.C., says in a news release.
Bipolar disorder -- previously called "manic-depressive" disease -- affects 2.5 million Americans and is a mental illness that causes people to have severe high and low moods. People with bipolar disorder have mood swings from feeling overly happy and joyful (or irritable), to feeling very sad (or overly happy). According to the National Institute of Mental Health, nearly one in every five people with the illness ends their life by suicide. In between episodes of mood swings, a person may experience normal moods.
The word "manic" describes the periods when the person feels overly excited and confident. These feelings can quickly turn to confusion, irritability, anger, and even rage. The word "depressive" describes the periods when the person feels very sad or depressed. Because the symptoms are similar, sometimes people with bipolar depression are incorrectly diagnosed as having major depression.
Zyprexa is the first medication approved to treat both acute mania and delay relapse of symptoms associated with bipolar disorder since lithium was approved in 1974. Zyprexa is also one of the ingredients in the drug Symbyax -- as well as one in the antidepressant Prozac -- which was recently approved to treat bipolar depression.
The FDA approved Zyprexa for long-term treatment of bipolar disorder based on a study that showed patients taking Zyprexa went significantly longer without relapse than patients taking placebo. An attack of mania occurred in 16% of Zyprexa-treated patients compared with 41% of placebo patients. In addition, depression relapse occurred in 35% of Zyprexa patients compared with 48% of patients taking placebo.
In the study, significant side effects for Zyprexa patients were weight gain, fatigue, and restlessness.
High blood sugar -- even associated with coma or death -- has been linked to medications such as Zyprexa. All patients taking these drugs should be routinely checked for symptoms of high blood sugar. People with diabetes should be monitored regularly for worsening of blood sugar control.