Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of WELLBUTRIN XL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. WELLBUTRIN XL is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
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WELLBUTRIN XL SUMMARY
WELLBUTRIN XL®
(bupropion hydrochloride extended-release tablets)
WELLBUTRIN XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.
WELLBUTRIN XL is indicated for the treatment of major depressive disorder.
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY).
A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use WELLBUTRIN XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
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NEWS HIGHLIGHTSMedia Articles Related to Wellbutrin XL (Bupropion)
Teva's High-Dose Generic Wellbutrin XL Withdrawn
Source: MedicineNet bupropion Specialty [2012.10.08]
Title: Teva's High-Dose Generic Wellbutrin XL Withdrawn
Category: Health News
Created: 10/8/2012 12:22:00 PM
Last Editorial Review: 10/8/2012 12:00:00 AM
Published Studies Related to Wellbutrin XL (Bupropion)
The DRD4 Exon III VNTR, Bupropion, and Associations With Prospective Abstinence. [2012]
cognitive-behavioral mood management therapy... CONCLUSIONS: VNTR by treatment interaction
A retrospective analysis of two randomized trials of bupropion for
methamphetamine dependence: suggested guidelines for treatment
discontinuation/augmentation. [2012]
BACKGROUND: Two clinical trials have shown efficacy for bupropion in treating
methamphetamine (MA) dependence among those with moderate baseline MA use. However, treatment response is highly variable and it is unclear what duration of
treatment is necessary to determine if maintaining the treatment course is
indicated or if discontinuation or augmentation is appropriate.
Smoking cessation pharmacogenetics: analysis of varenicline and bupropion in
placebo-controlled clinical trials. [2012]
Despite effective therapies for smoking cessation, most smokers find quitting
difficult and most successful quitters relapse. Considerable evidence supports a
genetic risk for nicotine dependence; however, less is known about the
pharmacogenetics of smoking cessation... Different loci are associated with varenicline vs bupropion
response, suggesting that additional research may identify clinically useful
markers to guide treatment decisions.
Effects of varenicline and bupropion on cognitive processes among
nicotine-deprived smokers. [2012]
Nicotine deprivation is associated with craving, negative affect, and difficulty
concentrating, which may contribute to subsequent relapse... Identifying these mechanisms may help in the development of new
pharmacological treatments.
Bupropion sustained release added to group support for smoking cessation in
schizophrenia: a new randomized trial and a meta-analysis. [2012]
CONCLUSIONS: New clinical trial data and a meta-analysis strongly support the
Clinical Trials Related to Wellbutrin XL (Bupropion)
Wellbutrin XL, Major Depressive Disorder and Breast Cancer [Completed]
- To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment
of Major Depressive Disorder in women with breast cancer.
- To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these
patients
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity [Completed]
The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL
(bupropion hydrochloride) on reward processing.
Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions [Recruiting]
The objective of this study is to evaluate the comparative bioavailability between bupropion
hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL®
300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients
under fasting conditions.
Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial [Recruiting]
Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent
event or death compared with those who quit. Many patients attempt to stop smoking after a
heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been
shown to be effective for the general population. However, bupropion is the only
non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers.
Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate
period following a heart attack because of the undesirable effects of nicotine. Although
bupropion has been successfully used to reduce smoking rates in healthy young populations,
its efficacy and safety in the setting of patients recovering from an ACS is unknown. These
patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac
events. If bupropion is effective in this population, it will have a major impact on
secondary prevention of recurrent clinical events in patients who suffer a heart attack.
Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients [Not yet recruiting]
This is a multi center, open-label study to study the drug-drug interaction of LDE225 on the
PK of warfarin and bupropion in patients with advanced solid tumors. Subjects will receive
800mg daily of LDE225 and two separate doses of either bupropion or warfarin.
Reports of Suspected Wellbutrin XL (Bupropion) Side Effects
Convulsion (21),
Drug Ineffective (19),
Depression (19),
Product Quality Issue (14),
Anxiety (13),
Tremor (11),
Agitation (10),
Product Substitution Issue (10),
Dizziness (10),
Confusional State (9), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 35 ratings/reviews, Wellbutrin XL has an overall score of 7.97. The effectiveness score is 7.94 and the side effect score is 7.83. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Wellbutrin XL review by 49 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | anti-depressant |
| Dosage & duration: | | 350 (dosage frequency: once a day) for the period of 2 years |
| Other conditions: | | n/a |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The biggest benefit was when I quit smoking, because I had been taking it for a while...it proved to assist with the cravings...it's probably why I was able to quit in the first place. |
| Side effects: | | Made me kind of grumpy and a little weight gain. |
| Comments: | | Started taking anti-depressant when my Mother passed away. Started a low-dose and increased over a period of 3 months. I believe Wellbuterin was very beneficial and did not have major side effects. I stopped taking them 2 months ago and haven't had any withdrawal symptoms. |
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| | Wellbutrin XL review by 56 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 150mg taken every am for the period of on going |
| Other conditions: | | thyroid, high cholesterol |
| Other drugs taken: | | Synthroid 25mg Simvastaton 20mg | | |
Reported Results |
| Benefits: | | Yes, I had taken Prozac for fourteen to fifteen years for the treatment of depession and experienced a loss of sexual desire. I tried the Wellbutrin XL in the hopes that it would not produce this side effect starting about 18 months ago. The Wellbutrin XL does not have this side effect in my experience. |
| Side effects: | | I have not noticed side effects. I was hoping that a good side effect would be that it would help me quit smoking. It hasn't. |
| Comments: | | I don't have any details. Have thought about asking my doctor to up the dosage when I was having a bout of feeling "down" but it passed and I didn't. |
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| | Wellbutrin XL review by 53 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | lose weight |
| Dosage & duration: | | 300mg taken 1x day for the period of 2 weeks |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Positive- increased libido |
| Side effects: | | Negative- 1)significant increase in breast pain on one side, leading to bloody discharge after only 2 weeks of taking drug 2)'coursing' feeling through veins on same side as breast pain 3)humongous hard pimple formed near nose. |
| Comments: | | Discontinued treatment due to side effects. I would consider taking again if the negative side effects were noted in literature as temporary and insignificant over the long term |
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Page last updated: 2013-02-10
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