To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Prozac For Seniors With Depression URL: http://www.pslgroup.com/dg/1369C6.htm Doctor's Guide October 7, 1999
INDIANAPOLIS, IN. -- October 7, 1999 -- The U.S. Food and Drug Administration has granted the antidepressant Prozac® (fluoxetine hydrochloride) an indication to treat geriatric depression-making Prozac the first antidepressant medication indicated for use in both adult and geriatric populations, Lilly announced today.
This approval, which confirms the safety and efficacy of Prozac for patients 65 and older, comes in the wake of a 1997 FDA ruling that requires all medications to have a "Geriatric Use" section in their labeling with information about drug safety and efficacy for elderly patients. No other antidepressant has received an indication for the treatment of depression in geriatric patients.
The National Institute of Mental Health (NIMH) estimates that of the 33 million Americans currently over the age of 65, approximately 6 million (18 percent) experience depressive symptoms, which can include persistent sadness, sleeplessness and changes in body weight. The NIMH also estimates that only 10 percent of the depressed elderly ever receive appropriate treatment for this illness.
"Depression in the elderly is a potentially life-threatening illness that should be taken seriously by physicians, caretakers and sufferers," said John Hayes, M.D., Medical Director, Lilly U.S. Neuroscience. "Depression is not a natural part of the aging process and should not be ignored by physicians or patients. The safety and efficacy of Prozac, well established since it was first approved by the FDA more than 11 years ago, should comfort doctors who treat elderly patients suffering from depression."
Nearly 700 depression patients age 65 and older have participated in double-blind placebo-controlled trials involving Prozac. Depressed patients using Prozac 20 milligrams daily responded significantly more often than those on placebo. Remission rates for patients on Prozac also were significant while the dropout rate due to adverse events, compared to placebo, was not significant for patients on Prozac. Data outlining the safety and efficacy profile of Prozac are published in the October issue of the International Journal of Geriatric Psychopharmacology.
"The undertreatment of geriatric depression remains a serious issue in our society - in part, because many people mistakenly believe that depression is normal for older people," said Rajinder Judge, M.D., Global Medical Director, Lilly Neuroscience Business Unit. "Published data reviewed by the FDA confirm that Prozac is a safe and effective treatment for older patients."
Background on depression
One consequence of untreated depression in the elderly is suicide. According to a recent report from the U.S. Surgeon General, the elderly comprise only 13 percent of the U.S. population but account for 20 percent of all suicide deaths - the highest rate among all age groups.
Several factors, including difficulty to diagnose, have led to the undertreatment of depression in older people. Depression often accompanies many illnesses that are common in the elderly, including Parkinson's disease, arthritis, chronic lung disease, cancer, diabetes and stroke. Signs of depression, such as difficulty sleeping and gastrointestinal upset, are often attributed to other physical illnesses rather than to depression-or are ignored entirely. Untreated depression can significantly impact quality of life and, research suggests, may impact health outcomes in some co-existing illnesses.
Stigma also plays a role in the underdiagnosis of depression. "Many older Americans may not seek treatment because they worry that depression will be seen as a character weakness instead of a biological disorder and medical illness," said Alan Siegal, M.D., Associate Professor of Psychiatry at Yale University. "This is tragic because depression is very treatable."
The perception that depression is a "natural" part of the aging process also impedes proper diagnosis. "While it may be understandable that losing a loved one, assuming a caregiver role for a spouse or dealing with a serious physical illness may trigger depression, it does not mean that the depression should be ignored or is less responsive to treatment," Siegal said.
Signs and Symptoms of Depression in the Elderly
Because depression in this population can be difficult to recognize, elderly patients and their caregivers should be aware of the most common symptoms of late-life depression. Some of the symptoms, according to the National Mental Health Association, include:
- persistent sadness (lasting two weeks or more)
- feeling slowed down
- excessive worries about finances and health problems
- frequent tearfulness
- feeling worthless or helpless
- weight changes
- pacing and fidgeting
- difficulty sleeping
- difficulty concentrating
- physical symptoms such as pain or gastrointestinal problems
About Prozac
In addition to depression, Prozac is currently indicated by the FDA for the treatment of obsessive compulsive disorder and bulimia nervosa. To date, more than 35 million people globally have been treated with Prozac.
The most commonly observed adverse events associated with the use of Prozac vs. placebo in U.S.-controlled clinical trials for depression, OCD and bulimia combined were: nausea (23 vs. 10 percent), headache (21 vs. 20 percent), insomnia (20 vs. 11 percent), anxiety (13 vs. 8 percent), nervousness (13 vs. 9 percent) and somnolence (13 vs. 6 percent).
Prozac is contraindicated until at least two weeks have passed since discontinuing an MAO inhibitor, and an MAO inhibitor is contraindicated for at least five weeks after discontinuation with Prozac.
Prozac should be discontinued immediately if rash or other possibly allergic phenomena appear for which an alternative etiology cannot be determined.
No overall differences in safety or effectiveness were observed between these geriatric clinical trial subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. As with other SSRIs, Prozac has been associated with cases of clinically significant hyponatremia in elderly patients. A lower or less frequent dosage should be considered for the elderly.
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