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Health Canada Drug safety reviews

Health Canada Drug safety reviews

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Published by torontostar
This is a list 24 drug safety reviews conducted by Health Canada in 2013. These reviews were triggered by reports of adverse reactions, information from a foreign regulator indicating a potential concern with a drug or through findings summarized in medical and scientific literature. Brief summary reports of these safety reviews will be posted online starting in the next few months. Some drugs are listed several times because they were the subject of more than one review.

This is a list 24 drug safety reviews conducted by Health Canada in 2013. These reviews were triggered by reports of adverse reactions, information from a foreign regulator indicating a potential concern with a drug or through findings summarized in medical and scientific literature. Brief summary reports of these safety reviews will be posted online starting in the next few months. Some drugs are listed several times because they were the subject of more than one review.

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Published by: torontostar on Apr 02, 2014
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05/20/2014

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From:
 Blossom Leung [mailto:blossom.leung@hc-sc.gc.ca]
Sent:
 Tuesday, November 12, 2013 3:30 PM
To:
 Zlomislic, Diana
Subject:
 Health Canada
 
Hello,
 
Please see below for the response to your questions.
 
Thank you for your patience,
 
Blossom
 
*****
 
Q1: Could I get a list of drugs that were the subject of the 150+ safety reviews that have been completed from January 2013 to Present?
 
Health Canada continuously reviews and communicates safety information for drugs marketed in Canada.
 
There are different categories of drug reviews. The first kind of drug review is related to our regular monitoring activities. These types of reviews include:
 
reviews of Risk Management Plans - drug monitoring plans submitted by the drug manufacturer for their marketed products.
 
Periodic Safety Update Reports, which are periodic reports submitted by the manufacturer used to report and analyse the safety data related to their products after marketing
 
Since January 2013, Health Canada has reviewed 128 of these monitoring related reports. The second kind of drug review, and likely the type of review that you are interested in, are safety reviews of pharmaceutical drugs. These drug reviews are conducted by Health Canada and include, when necessary, causality assessments for cases of serious adverse events and/or death.
 
Since January 2013, Health Canada has completed 24 safety reviews, which are listed below. Once these reviews are completed, Health Canada makes a regulatory determination, which may include label updates, risk communication or determination that no action required.
 
These two types of reviews together make a total of 152 files.
 
Table-1 provided below is a list of safety reviews that have been completed by Health Canada since January 2013. These do not include the monitoring related activities (Risk Management Plans or Periodic Safety Update Reports) as they are not safety reviews conducted by Health Canada.
 
Table 1: Signal Reviews with associated Causality Assessments
 
Project (generic/brand name/Class)
 
Project (Active Ingredient/Class)
 
 
1
 
QVAR
 
Beclomethasone
 
2
 
Benzodiazepines
 
Benzodiazepines
 
3
 
Miacalcin & Calcimar
 
Calcitonin (salmon synthetic) - Nasal Spray & injectable
 
4
 
Alvesco
 
Ciclesonide
 
5
 
Sensipar
 
Cinacalcet
 
6
 
Cymbalta
 
Duloxetine
 
7
 
Byetta
 
Exenatide
 
8
 
Fluoroquinolones Fluoroquinolones
 
9
 
GLEEVEC
 
Imitinib
 
10
 
Revlimid
 
Lenalidomide
 
11
 
Keppra
 
Levetiracetam
 
12
 
Keppra
 
Levetiracetam
13
 
Keppra
 
Levetiracetam
 
14
 
Antipsychotics Atypical
 
Olanzapine, risperidone, aripiprazole
 
15
 
Alimta
 
Pemetrexed Disodium
16
 
Propyl-Thyracil
 
Propylthiouracil
 
17
 
Seroquel
 
Quetiapine
18
 
Xarelto
 
Rivaroxaban
 
19
 
Zemuron
 
Rocuronium
 
20
 
Sutent (9677-S0237-11)
 
Sunitinib
 
21
 
Tridural
 
Tramadol
 
22
 
Champix
 
Varenicline
 
23
 
Zometa
 
Zoledronic acid
24
 
VEGF inhibitor (bevacizumab, ranibizumab, sunitinib, sorafenib, axitinib, pazopanib, regorafenib, vandetanib)
 
VEGF inhibitor (bevacizumab, ranibizumab, sunitinib, sorafenib, axitinib, pazopanib, regorafenib, vandetanib)
 
Q2: The Minister has has asked Health Canada to “take the steps necessary to begin publishing drug reviews transparently to ensure Canadians and medical professionals have the information they need and want.” What what are the next steps to publish these drug reviews? What needs to be done in order for these reviews to be published? Is there a timeline?
 
In the coming months, Health Canada will publish the first of these reviews.
 
*****
 
 _________________________________________ Blossom Leung Media Relations Officer | Agente des relations avec les médias Communications and Public Affairs Branch | Direction générale des affaires publiques et des communications Serving Health Canada and the Public Health Agency of Canada | Au service de Santé Canada et de l'Agence de la santé publique du Canada (t) 613.946.0668

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