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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 catachrest on December 23, 2005, at 8:53:36
FYI - Susan
PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on
Paxil (paroxetine)December 22, 2005
Subject: Additional Study Shows Use of Paroxetine in First Trimester of Pregnancy May Have Small Increased Risk of Heart-Related Birth Defects, Compared to Other Antidepressants
Mississauga, Ontario (December, 2005) - GlaxoSmithKline Inc. (GSK), following discussions with Health Canada, is providing an update on the use of paroxetine during the first trimester of pregnancy. A previous advisory was issued on this subject in October 2005, regarding preliminary results of an epidemiology study sponsored by GSK using a United States database. The results of that analysis suggested there may be a small increase in the risk of birth defects, including heart-related defects, in babies whose mothers were prescribed paroxetine in the first trimester of pregnancy, compared to other antidepressants. This second advisory is being issued as a result of new analysis of Swedish national registry data, which shows similar findings to those of the US study regarding heart-related defects, but unlike the US study, did not find an increased risk of overall birth defects.
The combined results from two large database studies now suggest that if the mother takes paroxetine in the first trimester of pregnancy, the risk of having a baby with a heart defect increases to approximately 2/100 (2 percent), as compared to approximately 1/100 (1 percent) with other antidepressants, or in the general population. Other antidepressants do not show this increased risk in these studies. Most of the heart-related defects were atrial or ventricular septal defects, conditions in which there are holes in the wall separating the left and right chambers of the heart.
Doctors have been advised to inform patients of this paroxetine-associated risk to the fetus.
Pregnant women currently taking paroxetine, who are in their first trimester, and those women who intend to become pregnant, should consult with their doctor about whether to continue taking it. Generally, paroxetine treatment should only be continued if the benefits for the individual patient are thought to outweigh the risks, while also considering the benefits and risks of switching to another treatment option, or stopping treatment altogether.
Due to the risk of discontinuation symptoms, it is very important that patients do NOT stop taking paroxetine without first consulting with their doctor.
If treatment for depression is to be started, other treatment options besides paroxetine should be considered for women who intend to become pregnant, or are in their first trimester.
Heart-related defects are one of the most common types of birth defects in the general population, occurring in about 1/100 infants, or 1 percent, regardless of whether the mother is being treated with antidepressants. In general, septal defects can range from those that are mild and repair themselves spontaneously as the child grows up, to those that are more serious and may require surgery. In the general population, the majority of cases are mild; however the severity of the paroxetine-associated septal defects reported in these studies is unknown.
The Canadian prescribing information and consumer information for PAXIL® (paroxetine hydrochloride tablets) and PAXIL CR™ (paroxetine hydrochloride controlled release tablets) currently includes a precaution that paroxetine should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. The Product Monograph also includes information related to possible symptoms and complications observed in newborns exposed to paroxetine, or other newer antidepressants, during the third trimester of pregnancy.
GlaxoSmithKline has sent a letter to health-care professionals informing them of this new safety information. This information may be obtained on the Canadian website of GlaxoSmithKline or on the Health Canada website. Following consultation with Health Canada, the Product Monograph for Paxil and Paxil CR will be revised. If patients have questions regarding their current Paxil or Paxil CR prescription, they are asked to contact their doctor or pharmacist.
For media inquiries, please contact Cathy Metson, (905) 819-3363.
PAXIL® is a registered trademark, used under license by GlaxoSmithKline Inc.
PAXIL CR™ is a trademark, used under license by GlaxoSmithKline Inc.Managing marketed health product-related adverse reactions depends on health-care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with drug treatments. Any cases of serious or unexpected adverse reactions in patients taking paroxetine should be reported to GlaxoSmithKline or Health Canada at the following addresses:
GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga, Ontario
L5N 6L4
Tel: 1-800-387-7374Any 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
cadrmp@hc-sc.gc.caThe 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.
For other inquiries related to this communication, please contact Health Canada at:
Bureau of Cardiology, Allergy and Neurological Sciences
BCANS_Enquiries@hc-sc.gc
Tel: (613) 941-1499
Fax: (613) 941-1668
Posted by utopizen on December 30, 2005, at 8:01:18
In reply to Public advisory: PAXIL, posted by catachrest on December 23, 2005, at 8:53:36
Thank you for the FYI, but...
this is Health Canada.
Health Canada previously banned the sale of Adderall XR, convinced isolated incidents of single-digit cases of cardic failures in children were triggered solely by Adderall XR.
They didn't ban Adderall, the immediate release, just XR.
That makes absolutely no sense, even if they were convinced Adderall XR was related-- um, what, did they think the slow-release was to blame?
Anyway, I think anything is important, as long as it's not from Health Canada.
If it matters, FDA will say it. Frankly, I'd listen to my mom before I listen to Health Canada. I'd listen to Peter Breggin before i listen to Health Canada. I'd take everything National Institute of Drug Abuse quacks say before I listen to Health Canada. I'd rather have the FDA not reveal speculative advisories so when they do make advisories, I know it's based on well-thought-out science, and not loose speculation.
If you're concerned, talk to your doctor. Sorry, i just can't get over how Health Canada is like, not publicly letting it be known they fired anyone involved in releasing the Adderall XR ban (not advisory, ban!) jeez.
Posted by Catachrest on December 30, 2005, at 20:34:18
In reply to Re: Public advisory: PAXIL, posted by utopizen on December 30, 2005, at 8:01:18
Hey utopizen, but I would just like to point out that Health Canada is a national federal department, and this advisory was originally issued by the drug company; Health Canada is simply publicizing it.
I don't know anything about the Aderall ban but, having worked for HC in the past, I have an idea of how huge this government department is and it is most likely that the incident you are referring to was an isolated one. Health Canada releases nothing to the public without careful scrutiny and they do have some of the best scientific minds in Canada. If you will pardon my saying it, I think you may be jumping to a bit of a conclusion based on little evidence (based only on what you post below). After all, they are Canada's equivalent to the FDA and they do have a few clues. :)
However, I do agree: if you are concerned, talk to your doctor.
> Thank you for the FYI, but...
>
> this is Health Canada.
>
> Health Canada previously banned the sale of Adderall XR, convinced isolated incidents of single-digit cases of cardic failures in children were triggered solely by Adderall XR.
>
> They didn't ban Adderall, the immediate release, just XR.
>
> That makes absolutely no sense, even if they were convinced Adderall XR was related-- um, what, did they think the slow-release was to blame?
>
> Anyway, I think anything is important, as long as it's not from Health Canada.
>
> If it matters, FDA will say it. Frankly, I'd listen to my mom before I listen to Health Canada. I'd listen to Peter Breggin before i listen to Health Canada. I'd take everything National Institute of Drug Abuse quacks say before I listen to Health Canada. I'd rather have the FDA not reveal speculative advisories so when they do make advisories, I know it's based on well-thought-out science, and not loose speculation.
>
> If you're concerned, talk to your doctor. Sorry, i just can't get over how Health Canada is like, not publicly letting it be known they fired anyone involved in releasing the Adderall XR ban (not advisory, ban!) jeez.
Posted by ed_uk on December 31, 2005, at 8:45:21
In reply to Re: Public advisory: PAXIL, posted by utopizen on December 30, 2005, at 8:01:18
>They didn't ban Adderall, the immediate release, just XR
>That makes absolutely no senseImmediate release Adderall was never marketed in Canada :)
Ed
Posted by utopizen on January 1, 2006, at 14:15:10
In reply to Re: Public advisory: PAXIL » utopizen, posted by ed_uk on December 31, 2005, at 8:45:21
Thank you for the two clarifications.
That said, Health Canada did indeed ban Adderall XR from the market based in isolated cases, and that kind of a decision is not done by isolated individuals, but from the highest officials of the Dept.
And the FDA and Health Canada are not in any means comparable. I don't mean to belittle it as an entire institution, but, the FDA's M.D.'s on their CNS Disorders Advisory Panel do nothing without the greatest scrutiny.
The FDA balked when Health Canada on Adderall XR and dismissed it as having no basis and entirely speculative.
The decision was ultimately repealed once they had to face reality, but I believe it was for several months that the ban was in effect, during which Adderall XR could not be sold.
If it's being passed on as an advisory, yeah, sorry for my oversight.
I just had a grudge, obviously, about Health Canada... it was a rant, I'll admit ;)
This is the end of the thread.
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