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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by Phillipa on December 3, 2009, at 0:12:24
For those who have relatives or themselves with any cardiac problems read below. Phillipa
From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts
Desipramine Increases Death Risk in Patients With Family History of Sudden Cardiac Death, Dysrhythmias
Deborah Brauser
December 2, 2009 The US Food and Drug Administration (FDA) and Sanofi-Aventis are warning healthcare professionals to use caution when prescribing the antidepressant desipramine hydrochloride (Norpramin) in patients with a family history of dysrhythmias or sudden cardiac death."The new safety information states that extreme caution should be used when this drugis given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances," according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.
The FDA and the manufacturer also warn that some patients may have seizures before cardiac dysrhythmias and death. Desipramine overdose is more likely to result in death than overdose with other tricyclic antidepressants, notes a company letter sent to healthcare professionals.
The "warnings" and "overdosage" sections of the drug's labeling are being changed to reflect these potential adverse events.
More information is available on the FDA's MedWatch Web site.
Adverse events and deaths related to desipramine should be reported to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852
Posted by iforgotmypassword on December 3, 2009, at 9:22:25
In reply to FDA Desipramine Alert, posted by Phillipa on December 3, 2009, at 0:12:24
if only we had a true equivalent to this NRI. the genotoxicity issue is also something that merits thorough investigation, i fear that it is very serious.
Posted by linkadge on December 4, 2009, at 22:17:18
In reply to thank you for the update, posted by iforgotmypassword on December 3, 2009, at 9:22:25
Yeah, you know the Europeans realized this years ago when they came to the conclusion that desipramine was innapropriate for childhood ADHD due to increase in sudden cardiac death.
I think the Americans are more slow to condem some of the older 'classics'.
Linkadge
Posted by softheprairie on December 6, 2009, at 3:42:19
In reply to FDA Desipramine Alert, posted by Phillipa on December 3, 2009, at 0:12:24
My pdoc gave me two printouts about these new warnings by the FDA and sanovi-aventis Wed. I have been stable on 300 mg desipramine plus other meds. Desipramine has been very helpful to me, when all other anti-depressants haven't or stopped. My father died of a heart attack when he was just 51. My dad was overweight, but my BMI is quite a bit higher than his was.
This really throws a wrench in my plans. I have paper orders from pdoc to get my EKG and blood level of desipramine checked again. I also just looked up the official prescribing info from the maker of the brand name form of it, even though I take the generic. The FDA-approved info I printed out from sanovi-aventis also advises to come off of desipramine before planned surgery. This really worries me -- coming off of it before surgery (I have been in the process of getting approved for a type of weight loss surgery, but I am stalling on proceeding with it at the moment, and was even before this new desipramine concern).
ARGGGGGGGGGGHHHHHHHHHHHHHHH!!! I fear it not working (or not as well) after having been off of it.
Right now, I think I'll discuss with pdoc at next week's apt maybe trying to taper down to 200 mg for a while, then re-evaluate.
Posted by Phillipa on December 6, 2009, at 19:48:40
In reply to Re: FDA Desipramine Alert, posted by softheprairie on December 6, 2009, at 3:42:19
I'm sorry but glad you pdoc is being cautious especially with family history. Good luck and let us know okay? Love Phillipa
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