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Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 1 to 8 of 8. This is the beginning of the thread.
Posted by catachrest on June 14, 2004, at 16:57:14
From the Health Canada website at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/wellbutrin_zyban_hpc_e.html
June 8, 2004
Subject: Stronger WARNING for SSRIs and other newer anti-depressants regarding the potential for behavioural and emotional changes, including risk of self harm.
Dear Health Care Professional,
Biovail Pharmaceuticals Canada (BPC), following discussions with Health Canada, would like to inform you of important safety information regarding the possibility that SSRIs (selective serotonin reuptake inhibitors) and other newer antidepressants, including bupropion HCl, may be associated with behavioural and emotional changes, including risk of self harm.
Bupropion is marketed in Canada as both the anti-depressant WELLBUTRIN® SR and the smoking cessation drug ZYBAN®. As findings from post-market spontaneous reports regarding agitation type events apply to ZYBAN® as well as WELLBUTRIN® SR, the following Class warning is therefore being incorporated into the labelling of both products.
This warning applies to both adults and pediatrics. Please note that neither WELLBUTRIN® SR nor ZYBAN® have been fully evaluated in pediatrics, and these products are not indicated for use in patients less than 18 years of age.
POTENTIAL ASSOCIATION WITH THE OCCURRENCE OF BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM
In WELLBUTRIN® SR labelling only:
Pediatrics: Placebo-Controlled Clinical Trial DataRecent analyses of placebo-controlled clinical trial safety databases from SSRIs and other newer anti-depressants suggests that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.
The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs.
In both WELLBUTRIN® SR and ZYBAN® labelling:
Adults and Pediatrics: Additional dataThere are clinical trial and post-marketing reports with SSRIs and other newer anti-depressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization. In some cases, the events occurred within several weeks of starting treatment. Given that bupropion may be prescribed as either an anti-depressant (WELLBUTRIN® SR) or a smoking cessation product (ZYBAN®), these findings affect the conditions of use of both products.
Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages given an anti-depressant drug. This includes monitoring for agitation-type emotional and behavioural changes. Although the smoking cessation patient population is not taking bupropion for depression, agitation-type changes are reported for ZYBAN® and monitoring is necessary for both products.
It should be noted that a causal role for anti-depressants in inducing self-harm or harm to others has not been established. The possibility of a suicide attempt is inherent in depression and other psychiatric disorders, and may persist until remission occurs. Therefore, high risk patients should be closely supervised throughout therapy with appropriate consideration to the possible need for hospitalization. The updated WARNING informs practitioners that all patients being treated with SSRIs or other newer anti-depressants should be rigorously monitored for clinical worsening, or onset/worsening of agitation-type adverse events or other indicators with a potential for suicidal behaviour.
New Information Added to the Consumer Information Section
The Consumer Information section of the product monographs has also been updated to reflect this new Class warning, and to advise patients that treatment with SSRIs and other newer anti-depressants is most safe and effective when there is good communication with the treating physician about how the patient is feeling.
Background
In February 2004, a Scientific Advisory Panel set up by Health Canada was asked to provide the clinical practice perspective on the pediatric clinical trial safety data, and the spontaneous post-marketing reports for SSRIs, SNRIs (serotonin and norepinephrine reuptake inhibitors) and other newer antidepressants. The Panel agreed that a contraindication was not warranted for these drugs and supported Health Canada’s recommendations for stronger warnings, while providing suggestions and comments. The Record of Proceedings, and other information about the Panel, can be found on the Health Canada website at: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/sap_ssri_2004-02-20_rop_e.html. Subsequently Health Canada, in discussion with the Advisory Panel, decided to include bupropion, a NDRI (noradrenalin and dopamine reuptake inhibitor), in the warning due to case reports of labile emotions, predominantly exemplified by agitation.
Biovail Pharmaceuticals Canada continues to work closely with Health Canada to monitor adverse event reporting and to ensure that up-to-date information regarding the use of WELLBUTRIN® SR and ZYBAN® is available.
The identification, characterization and management of drug-related adverse events are dependent on the active participation of healthcare professionals in adverse drug reaction reporting programs. HealthCare professionals are asked to report any suspected adverse reactions in patients receiving WELLBUTRIN® SR or ZYBAN® directly to Biovail Pharmaceuticals Canada or Health Canada at the following addresses:
Biovail Pharmaceuticals Canada
7150 Mississauga Rd.
Mississauga, Ontario.
L5N 8M5
Tel: 866-825-8120
Fax: 905-286-3256Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
[email protected]For other inquiries: please refer to contact information.
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.
Any questions from healthcare professionals may be directed to Biovail Pharmaceuticals Canada Medical Information services at 1-866-825-8120.
Sincerely,
original signed by
Kenneth Michalko, Pharm.D., MBA
Vice President, Regulatory Affairs
Biovail Pharmaceuticals Canada
Posted by Megs on June 15, 2004, at 15:43:10
In reply to Wellbutrin/Zyban (Bupropion) warning, posted by catachrest on June 14, 2004, at 16:57:14
After reading that I was thinking about how my 14 year old sister is on 300mg/day of Wellbutrin XL. I've only been home for a little over a month, but since i've been home shes turned into a completly different person. She has so much anger now, and completly doesn't care about the consequences of her actions. She also has no sympathy for anyone. My family is going through a really bad divorce right now and so im sure that some of her new personality is because of this, but I miss the old her. She used to be happy, nice, and compassionate and it makes me sad to see her like this. Do you think that the Wellbutrin has anything to do with the change? Or is it just the situation she is in, and that shes 14? Any thoughts would be helpful. Thanks.
Posted by partlycloudy on June 15, 2004, at 17:10:59
In reply to Re: Wellbutrin/Zyban (Bupropion) warning, posted by Megs on June 15, 2004, at 15:43:10
I'm on 300mg of wellbutrin xl in addition to effexor xr 150mg. the wb kind of "jacks me up" but I would not say it's made me aggressive in the least.
If anything, my anger was far less controllable before I started these medications.
Being 14 has so-o-o-o-o much to do with being angry!!!
Posted by HappyGirl on June 16, 2004, at 17:57:30
In reply to Re: Wellbutrin/Zyban (Bupropion) warning, posted by Megs on June 15, 2004, at 15:43:10
Hi Megs:
I would say it might be 'both.' One is your sister is 14 years old, which is quite a trasistional point in her life. Also, your/her family situation, .... to divorce/unhappy family life, on which she might be taking 'pretty' hard.In regard to 'Wellbutrin XL,' .... this med. is a sort stimulant effect along with good property of depressive efficacy. However, due to 'stimulant' effect, some of folks complain about 'anxiety' by taking WB. On top of this, WB brings up 'irritability,' 'insomnia' and all other 'nasty' problems ... so to speak, 'side-effect' from taking WB. But, keep in mind that this does NOT happen to everybody, ... just some/few of people on WB XL.
In my suggestion, if you have time, it is a good idea to go along with your sister at her next appt., because M.I. is quite a 'puzzle,' if you don't have one.
H.G.
Posted by pellmell on June 19, 2004, at 13:47:50
In reply to Re: Wellbutrin/Zyban (Bupropion) warning, posted by Megs on June 15, 2004, at 15:43:10
> After reading that I was thinking about how my 14 year old sister is on 300mg/day of Wellbutrin XL. I've only been home for a little over a month, but since i've been home shes turned into a completly different person. She has so much anger now, and completly doesn't care about the consequences of her actions. She also has no sympathy for anyone. My family is going through a really bad divorce right now and so im sure that some of her new personality is because of this, but I miss the old her. She used to be happy, nice, and compassionate and it makes me sad to see her like this. Do you think that the Wellbutrin has anything to do with the change? Or is it just the situation she is in, and that shes 14? Any thoughts would be helpful. Thanks.
* *
A day or two after I worked up to 300 mg Wellbutrin, I was a total mess. I got terribly irritable and anxious -- I would snap at anyone in my family who provoked me even slightly. Of course it was all made worse by the fact that I'd just come home from school for the summer...
On the other hand, I was seriously driven and bursting with (anxious) energy, which was kind of nice... I'd always been really short on both of those things! I dug up and replanted our vegetable garden myself, etc.
The anxiety got the better of me, though. I'd always been pretty easy on my pdoc -- almost never calling between visits, etc. During my trial of WB, though, I must've called him four or five times! Eventually we switched me to something else, but that's another series of stories.
So anyway, I wouldn't be surprised if your sis's behavior had quite a lot to do with the Wellbutrin. It takes years of experience with these drugs to understand what they do to you even after you have a fairly good idea of who you are, so I imagine your sister isn't even sure what's going on with her.
-pm
Posted by bride2be on June 20, 2004, at 17:23:35
In reply to Re: Wellbutrin/Zyban (Bupropion) warning//Megs, posted by HappyGirl on June 16, 2004, at 17:57:30
it made me crazy. i tried it and i guess i was one of the people that it does not work well for. my doc tried to give me well. twice, both times it made me soooooooo angry and down right mean. kinda like a killer blonde from a horror movie. but for real, it did not work for me. but on the other side, my dad and 2 aunts love it. hmmmm, everyones different.
Posted by Sebastian on June 22, 2004, at 11:35:57
In reply to Re: Wellbutrin/Zyban (Bupropion) warning//Megs, posted by bride2be on June 20, 2004, at 17:23:35
Thats interesting, the wellbutrin made you angry. I've had a little problem with anger too lately. I've been blaming it on other meds at the wrong dose. But come to think of it the anger has only been since I take wellbutrin!
I would like to stop the wellbutrin, but, it keeps me happy smoking less, much less. And the energy, not that I need 300 mg worth.
Posted by Megs on June 25, 2004, at 17:54:03
In reply to Re: Wellbutrin/Zyban (Bupropion) warning//Megs, posted by Sebastian on June 22, 2004, at 11:35:57
Well, my little sister is going off her meds now... she was on Adderall and Wellbutrin and her therapist has noticed the change in her too (we see the same therapist and I mentioned it to her as well) so for the summer at least she'll have a break from them. Hopefully she'll calm down some. Im on Adderall and Wellbutrin as well, but it works really well for me... hmm
This is the end of the thread.
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Dr. Bob is Robert Hsiung, MD,
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