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 2 3 4 5 6 7 8 9

QVAR Benzodiazepines Miacalcin & Calcimar Alvesco Sensipar Cymbalta Byetta Fluoroquinolones GLEEVEC

Beclomethasone Benzodiazepines Calcitonin (salmon synthetic) - Nasal Spray & injectable Ciclesonide Cinacalcet Duloxetine Exenatide Fluoroquinolones Imitinib Lenalidomide Levetiracetam Levetiracetam Levetiracetam Olanzapine, risperidone, aripiprazole Pemetrexed Disodium Propylthiouracil Quetiapine Rivaroxaban Rocuronium Sunitinib Tramadol Varenicline Zoledronic acid VEGF inhibitor (bevacizumab, ranibizumab, sunitinib, sorafenib, axitinib, pazopanib, regorafenib, vandetanib)

10 Revlimid 11 Keppra 12 Keppra 13 Keppra 14 Antipsychotics Atypical 15 Alimta 16 Propyl-Thyracil 17 Seroquel 18 Xarelto 19 Zemuron 20 Sutent (9677-S0237-11) 21 Tridural 22 Champix 23 Zometa 24 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

(e) Government of Canada | Gouvernement du Canada