FDA approves Wellbutrin XL for SAD
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Thread Starter
Join Date: Oct 2003
Location: Rhode Island
Posts: 9,293
FDA approves Wellbutrin XL for SAD
I had my appointment with my prescriber this past week.
She wants me to stay on the antidepressant for at least a full year, as this is my second depression. I'm 52; both depressions have been situational; both situations have been severe and long term stressors.
Today, I'm out of that situation, and into a much better situation at work. I feel great! I've lowered the dosage of the Wellbutrin from 200 mg to 100 mg on my own. I was starting to get signs of panic attacks from it again, as I've had in the past, when I was on 300 mg. (She wanted me on 300 mg; I said no for this reason.) Anyway, I'm doing very well as I said.
Also, it's springtime. I'm outside, doing things, seeing people again. I no longer have a medical condition that prevented me from exercising all winter long, (that also contributed to my depression).
At my appointment, I specifically asked about SAD treatment. She suggested a light box; very expensive - *if* they work. I'm not willing, or able, to fork out over $500 to find out it doesn't work!
I specifically asked about a medication for wintertime only. She insisted that there was none available. I was disappointed, but, she said to research the light boxes, and see what I could find.
This is what I found. It was from 2006, and she's not aware of it!!! :wtf2
We also talked about me going back to my regular doctor for my meds, since I am doing so well.
As she is not very well up to date on the medical research, I might as well.
I'm going to go off the Wellbutrin for the summer. I didn't like the idea of taking it when I was feeling so good. I don't like taking meds for nothing. But, this fall, I very much intend to take the Wellbutrin XL for my well established SAD. Had I had that this past winter, I may not have gone into the depression as a result of the stressors and lack of exercise and long harsh winter. I'm not going to let *this* happen again. I know I've had SAD for years; so does my counselor.
So, don't depend upon your pdoc being up to date and knowledgable. Once more, I've been let down by them. Last time, years ago, they called me permanently disabled, and told me to go on disablility!
Frankly, I don't think I"ll ever trust one again. :thefinger
But, please know, if you suffer from SAD, there *IS* treatment, besides an expensive lightbulb!
Peace!
She wants me to stay on the antidepressant for at least a full year, as this is my second depression. I'm 52; both depressions have been situational; both situations have been severe and long term stressors.
Today, I'm out of that situation, and into a much better situation at work. I feel great! I've lowered the dosage of the Wellbutrin from 200 mg to 100 mg on my own. I was starting to get signs of panic attacks from it again, as I've had in the past, when I was on 300 mg. (She wanted me on 300 mg; I said no for this reason.) Anyway, I'm doing very well as I said.
Also, it's springtime. I'm outside, doing things, seeing people again. I no longer have a medical condition that prevented me from exercising all winter long, (that also contributed to my depression).
At my appointment, I specifically asked about SAD treatment. She suggested a light box; very expensive - *if* they work. I'm not willing, or able, to fork out over $500 to find out it doesn't work!
I specifically asked about a medication for wintertime only. She insisted that there was none available. I was disappointed, but, she said to research the light boxes, and see what I could find.
This is what I found. It was from 2006, and she's not aware of it!!! :wtf2
FDA News
June 12, 2006
Consumer Inquiries:
888-INFO-FDA
FDA Approves the First Drug for Seasonal Depression
The Food and Drug Administration (FDA) today approved Wellbutrin XL for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). This is the first drug approved for SAD. Wellbutrin XL (bupropion HCL extended release tablets) previously was approved for treatment of major depressive disorder.
SAD is characterized by recurrent major depressive episodes that usually coincide with the seasonal decrease of daylight during autumn and winter. The depressive episodes can last up to 6 months. Although patients with SAD may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the non-seasonal episodes during the individual's lifetime.
A major depressive episode is defined as the presence of 5 or more of the 9 core symptoms of major depression for at least 2 weeks. The symptoms include: depressed mood; loss of interest; weight loss (or other weight or appetite changes); insomnia or hypersomnia; agitation or psychomotor retardation; fatigue; feelings of worthlessness or guilt; impaired concentration; suicidal thinking or behavior. One of the 5 symptoms must be either depressed mood or loss of interest in activities. Another essential feature of major depression is the presence of significant distress or impairment in social, occupational, or other important areas of functioning. A seasonal major depressive episode is defined by the identical features.
“Seasonal affective disorder can significantly impair the quality of life of patients with this condition,” said Dr. Steven Galson, Director for FDA’s Center of Drugs and Research. “Today’s approval can help patients with this condition to avoid the depressive symptoms and impaired functioning that typically affect them in the fall and winter.”
The effectiveness of Wellbutrin XL for the prevention of SAD episodes was established in 3 double-blind, placebo-controlled trials in adults with a history of major depressive disorder in autumn and winter. Treatment was initiated prior to the onset of symptoms in the autumn (September to November) and was discontinued following a two-week taper that began the first week of spring (fourth week of March). In these trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for those on Wellbutrin XL than for those on placebo; for all 3 studies combined, the overall rate of patients depression-free at the end of treatment was 84 percent for those on Wellbutrin XL compared to 72 percent for those on placebo.
Wellbutrin XL’s labeling includes a “black box” warning concerning the increased risk of suicidal thoughts and behavior in pediatric patients treated with antidepressant medications. As with all antidepressants, Wellbutrin XL has a Medication Guide (MedGuide, or patient labeling) advising that pediatric patients on antidepressants should be watched closely for these serious symptoms. Important side effects to watch for with Wellbutrin XL, especially shortly after the initiation of the treatment, include agitation, anxiety and insomnia. Wellbutrin was safe and well tolerated by patients in the SAD trials.
It is important to note that Wellbutrin XL is indicated only for patients who meet strict diagnostic criteria of seasonal major depressive episodes. Such patients have a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning. The clinician and patient should carefully assess the potential risks and benefits when considering treatment with Wellbutrin XL for SAD.
Wellbutrin XL is manufactured by GlaxoSmithKline.
June 12, 2006
Consumer Inquiries:
888-INFO-FDA
FDA Approves the First Drug for Seasonal Depression
The Food and Drug Administration (FDA) today approved Wellbutrin XL for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). This is the first drug approved for SAD. Wellbutrin XL (bupropion HCL extended release tablets) previously was approved for treatment of major depressive disorder.
SAD is characterized by recurrent major depressive episodes that usually coincide with the seasonal decrease of daylight during autumn and winter. The depressive episodes can last up to 6 months. Although patients with SAD may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the non-seasonal episodes during the individual's lifetime.
A major depressive episode is defined as the presence of 5 or more of the 9 core symptoms of major depression for at least 2 weeks. The symptoms include: depressed mood; loss of interest; weight loss (or other weight or appetite changes); insomnia or hypersomnia; agitation or psychomotor retardation; fatigue; feelings of worthlessness or guilt; impaired concentration; suicidal thinking or behavior. One of the 5 symptoms must be either depressed mood or loss of interest in activities. Another essential feature of major depression is the presence of significant distress or impairment in social, occupational, or other important areas of functioning. A seasonal major depressive episode is defined by the identical features.
“Seasonal affective disorder can significantly impair the quality of life of patients with this condition,” said Dr. Steven Galson, Director for FDA’s Center of Drugs and Research. “Today’s approval can help patients with this condition to avoid the depressive symptoms and impaired functioning that typically affect them in the fall and winter.”
The effectiveness of Wellbutrin XL for the prevention of SAD episodes was established in 3 double-blind, placebo-controlled trials in adults with a history of major depressive disorder in autumn and winter. Treatment was initiated prior to the onset of symptoms in the autumn (September to November) and was discontinued following a two-week taper that began the first week of spring (fourth week of March). In these trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for those on Wellbutrin XL than for those on placebo; for all 3 studies combined, the overall rate of patients depression-free at the end of treatment was 84 percent for those on Wellbutrin XL compared to 72 percent for those on placebo.
Wellbutrin XL’s labeling includes a “black box” warning concerning the increased risk of suicidal thoughts and behavior in pediatric patients treated with antidepressant medications. As with all antidepressants, Wellbutrin XL has a Medication Guide (MedGuide, or patient labeling) advising that pediatric patients on antidepressants should be watched closely for these serious symptoms. Important side effects to watch for with Wellbutrin XL, especially shortly after the initiation of the treatment, include agitation, anxiety and insomnia. Wellbutrin was safe and well tolerated by patients in the SAD trials.
It is important to note that Wellbutrin XL is indicated only for patients who meet strict diagnostic criteria of seasonal major depressive episodes. Such patients have a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning. The clinician and patient should carefully assess the potential risks and benefits when considering treatment with Wellbutrin XL for SAD.
Wellbutrin XL is manufactured by GlaxoSmithKline.
As she is not very well up to date on the medical research, I might as well.
I'm going to go off the Wellbutrin for the summer. I didn't like the idea of taking it when I was feeling so good. I don't like taking meds for nothing. But, this fall, I very much intend to take the Wellbutrin XL for my well established SAD. Had I had that this past winter, I may not have gone into the depression as a result of the stressors and lack of exercise and long harsh winter. I'm not going to let *this* happen again. I know I've had SAD for years; so does my counselor.
So, don't depend upon your pdoc being up to date and knowledgable. Once more, I've been let down by them. Last time, years ago, they called me permanently disabled, and told me to go on disablility!
Frankly, I don't think I"ll ever trust one again. :thefinger
But, please know, if you suffer from SAD, there *IS* treatment, besides an expensive lightbulb!
Peace!
*~10 YEARS BABY~*
Join Date: Nov 2005
Location: Hollywood
Posts: 9,369
I had heard of that before. I agree about not trusting your docs to know everything.
I think there is far too much info. out there to expect them to know everything these days...
Thanks TEach!
I think there is far too much info. out there to expect them to know everything these days...
Thanks TEach!
To Life!
Thread Starter
Join Date: Oct 2003
Location: Rhode Island
Posts: 9,293
True enough; we cannot expect anyone to know everything.
But, this information was out since 2006.
And she was *insistent* that there was *no* medication that could be taken just for the seasons of SAD for treatment.
Indeed, she went on to say that it would be counterproductive, cuz, to take a med, and stop, and take it again, would cause the med to stop working.
This is the exact opposite of what the FDA has approved Wellbutrin XL for. It's only to be taken for SAD during the winter months, and then stopped!
So, she didn't know something, and went on telling complete stories about that which she didn't know.
Wouldn't it have been better for her to just say, "I'm not aware of any med for that purpose." Or, "I don't know." When a kiddie asks me a question at school that I don't know, I have *no* problem saying, "I don't know." Because it *is* impossible for anyone of us to know all.
What I'm upset about is that she didn't know, but, made it out *as if* she DID know.
In short, isn't that dishonest?
Feels like it to me, anyway.
Some people just cannot get past their pride to say, "I don't know." And what problems that causes.
I'm printing this out and sending it to her.
I probably gave you more of my thoughts than you ever asked for or wanted, huh???
Shalom!
But, this information was out since 2006.
And she was *insistent* that there was *no* medication that could be taken just for the seasons of SAD for treatment.
Indeed, she went on to say that it would be counterproductive, cuz, to take a med, and stop, and take it again, would cause the med to stop working.
This is the exact opposite of what the FDA has approved Wellbutrin XL for. It's only to be taken for SAD during the winter months, and then stopped!
So, she didn't know something, and went on telling complete stories about that which she didn't know.
Wouldn't it have been better for her to just say, "I'm not aware of any med for that purpose." Or, "I don't know." When a kiddie asks me a question at school that I don't know, I have *no* problem saying, "I don't know." Because it *is* impossible for anyone of us to know all.
What I'm upset about is that she didn't know, but, made it out *as if* she DID know.
In short, isn't that dishonest?
Feels like it to me, anyway.
Some people just cannot get past their pride to say, "I don't know." And what problems that causes.
I'm printing this out and sending it to her.
I probably gave you more of my thoughts than you ever asked for or wanted, huh???
Shalom!
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