Canada Vigilance Summary of Reported Adverse Reactions Search Criteria Report Runtime: 2013-06-06 - 2:42:14 PM Range for Initial Receive Date: 1965-01-01 to 2013-02-28 Product Description: YASMIN 28 YASMIN YASMIN 21 YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Product Role: Suspect Dosage Form: -All- Route of Administration: -All- Range for Age (years): -All- Patient Gender: -All- Case Serious? -All- Case Outcome: Death Report Source: -All- Reporter Type: -All- Domestic or Foreign: Domestic CAVEAT: This summary is based on information from adverse event reports submitted by health professionals and laypersons either directly to Health Canada or via market authorization holders. Each report represents the suspicion, opinion or observation of the individual reporter. The Canada Vigilance Program is a spontaneous reporting system that is suitable to detect signals of potential health product safety issues during the post-market period. The data has been collected primarily by a spontaneous surveillance system in which adverse reactions to health products are reported on a voluntary basis. Under reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems. Accumulated case reports should not be used as a basis for determining the incidence of a reaction or estimating risk for a particular product as neither the total number of reactions occurring, nor the number of patients exposed to the health product is known. Because of the multiple factors that influence reporting, quantitative comparisons of health product safety cannot be made from the data. Some of these factors include the length of time a drug is marketed, the market share, size and sophistication of the sales force, publicity about an adverse reaction and regulatory actions. In some cases, the reported clinical data is incomplete and there is not certainty that these health products caused the reported reactions. A given reaction may be due to an underlying disease process or to another coincidental factor. This information is provided with the understanding that the data will be appropriately referenced and used in conjunction with this caveat statement. (10/2007) i YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Occurrences by Primary System Organ Class (SOC) Infections and infestations 5.6 % Psychiatric disorders 11.1 % Nervous system disorders 44.4 % Cardiac disorders Vascular disorders 33.3 % 5.6 % Respiratory, thoracic and mediastinal disorders 55.6 % Gastrointestinal disorders Musculoskeletal and connective tissue disorders 11.1 % 5.6 % General disorders and administration site conditions 16.7 % Investigations 16.7 % Injury, poisoning and procedural complications Total No. of Reports: (Denominator) 18 11.1 % Number of reports (percentage) with one or more reaction terms in the SOC(s) above Reason for Seriousness Serious Reports Death Patient Summary 18 LifeThreatening Hospitalization Required 1 Disability Congenital Anomaly 100 % 0 Other Medically Imp Condition 5 100 % 0 4 Female Yes Total Number of Reports Yes MedDRA V16.0 18 18 Female 18 YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Duplicate Report Information Aer No 000321127 Version No. Initial Rec. Date Latest Rec. Date 7 2009-03-31 2012-11-14 Report Source MAH MAH Number WAES0902CAN00119 Record Type Link Aer Number Serious Report? Duplicate 000358593 Yes Type of Report Published Death: Yes Life Threatening: Reporter Type Physician Disability: Hospitalization: Congenital Anomaly: Yes Other Medically Imp Condition: Patient Information Age 14 Years Gender Female Height Weight Report Outcome Death Product Information Product Description Product Role Dosage Form Route GARDASIL Suspect SUSPENSION INTRAMUSCULAR Parenteral YASMIN 28 Suspect TABLET Dosing Frequency 1 Dosage forms Therapy Duration Once Oral INFLUENZA VACCINE Concomitant Once 78 Day(s) NOT SPECIFIED Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Abasia Asthenia MedDRA V16.0 Basilar migraine MedDRA V16.0 Blood glucose increased MedDRA V16.0 Brain herniation MedDRA V16.0 Brain oedema MedDRA V16.0 Cardiac arrest MedDRA V16.0 Confusional state MedDRA V16.0 Dizziness postural MedDRA V16.0 Hypoxic-ischaemic encephalopathy MedDRA V16.0 Loss of consciousness MedDRA V16.0 Nausea MedDRA V16.0 Sudden death MedDRA V16.0 Syncope MedDRA V16.0 Vomiting MedDRA V16.0 Page 1 of 14 Duration Yes YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000326984 Version No. Initial Rec. Date Latest Rec. Date 4 2009-07-16 2011-12-15 Report Source MAH MAH Number 200926100NA Record Type Link Aer Number Serious Report? Duplicate 000327129 Type of Report Spontaneous Death: Yes Yes Reporter Type Pharmacist Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 26 Years Gender Female Height Weight 135 Kilograms Report Outcome Death Product Information Product Description Product Role Dosage Form Route YASMIN 28 Suspect TABLET Oral NAPROXEN Concomitant NOT SPECIFIED Concomitant POWDER Concomitant Therapy Duration 1 Dosage forms 1 every 1 Day(s) 101 Day(s) Unknown VENTOLIN Frequency Oral SYMBICORT TURBUHALER Dosing NOT SPECIFIED Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Cardiac arrest Dyspnoea MedDRA V16.0 Hypoxia MedDRA V16.0 Loss of consciousness MedDRA V16.0 Pulmonary embolism MedDRA V16.0 Page 2 of 14 Duration Yes YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000327129 Version No. Initial Rec. Date Latest Rec. Date 0 2009-07-21 2009-07-21 Report Source Community MAH Number Record Type Link Aer Number Serious Report? Duplicate 000326984 Type of Report Spontaneous Death: Yes Yes Reporter Type Other Health Professional Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 26 Years Gender Female Height 170 Centimetres Weight 298 Pounds Report Outcome Death Product Information Product Description Product Role Dosage Form Route YASMIN 28 Suspect TABLET Oral NAPROXEN Concomitant NOT SPECIFIED Concomitant POWDER Frequency Therapy Duration 1 Dosage forms 1 every 1 Day(s) 101 Day(s) Unknown SYMBICORT TURBUHALER Dosing Unknown Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Pulmonary embolism Page 3 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000358593 Version No. Initial Rec. Date Latest Rec. Date 0 2010-12-24 2010-12-24 Report Source MAH MAH Number 2010004848 Record Type Link Aer Number Serious Report? Duplicate 000321127 Type of Report Spontaneous Death: Yes Yes Life Threatening: Reporter Type Other Health Professional Disability: Hospitalization: Congenital Anomaly: Yes Other Medically Imp Condition: Patient Information Age 14 Years Gender Female Height Weight Report Outcome Death Product Information Product Description Product Role Dosage Form Route Dosing Frequency Therapy Duration GARDASIL Suspect SUSPENSION INTRAMUSCULAR Subcutaneous GARDASIL Suspect SUSPENSION INTRAMUSCULAR Unknown 1 Day(s) YASMIN 21 Suspect TABLET Unknown 61 Day(s) NOT SPECIFIED Unknown INFLUENZA VACCINE Concomitant 1 Day(s) Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Abasia Asthenia MedDRA V16.0 Basilar migraine MedDRA V16.0 Blood glucose increased MedDRA V16.0 Cardiac arrest MedDRA V16.0 Confusional state MedDRA V16.0 Dizziness postural MedDRA V16.0 Drowning MedDRA V16.0 Loss of consciousness MedDRA V16.0 Nausea MedDRA V16.0 Syncope MedDRA V16.0 Vomiting MedDRA V16.0 Page 4 of 14 Duration Yes YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000442802 Version No. Initial Rec. Date Latest Rec. Date 0 2012-06-12 2012-06-12 Report Source Community MAH Number Record Type Link Aer Number Serious Report? Duplicate 000446210 Type of Report Spontaneous Death: Yes Yes Reporter Type Physician Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 32 Years Gender Female Height Weight Report Outcome Death Product Information Product Description YASMIN 28 ASTHMA MEDICATIONS Product Role Suspect Concomitant Dosage Form TABLET Route Dosing Frequency Therapy Duration Unknown NOT SPECIFIED Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Cardiac arrest Ventricular fibrillation MedDRA V16.0 Page 5 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000446210 Version No. Initial Rec. Date Latest Rec. Date 0 2012-06-25 2012-06-25 Report Source MAH MAH Number 2012058573 Record Type Link Aer Number Serious Report? Duplicate 000442802 Type of Report Spontaneous Death: Yes Yes Life Threatening: Reporter Type Lawyer Disability: Hospitalization: Congenital Anomaly: Yes Other Medically Imp Condition: Patient Information Age 32 Years Gender Female Height Weight Report Outcome Death Product Information Product Description YASMIN 21 ASTHMA MEDICATIONS Product Role Suspect Concomitant Dosage Form TABLET Route Dosing Frequency Therapy Duration Unknown NOT SPECIFIED Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Arrhythmia Cardiac arrest MedDRA V16.0 Page 6 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions No Duplicate or Linked Reports Report Information Aer No 000224355 Version No. Initial Rec. Date Latest Rec. Date 0 2007-12-03 2007-12-03 Record Type Report Source MAH MAH Number CA2007039345 Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Physician Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 23 Years Gender Female Height Weight Report Outcome Death Product Information Product Description YASMIN 28 Product Role Suspect Dosage Form TABLET Route Dosing Frequency Therapy Duration Oral 91 Day(s) Reaction Information Convulsion MedDRA Preferred Term MedDRA Version MedDRA V16.0 Dyspnoea MedDRA V16.0 Loss of consciousness MedDRA V16.0 Pulmonary embolism MedDRA V16.0 Page 7 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000302699 Version No. Initial Rec. Date Latest Rec. Date 0 2008-04-30 2008-04-30 Record Type Report Source Community MAH Number 200910268NA Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Other Health Professional Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 23 Years Gender Female Height 173 Centimetres Weight 124 Kilograms Report Outcome Death Product Information Product Description YASMIN 28 Product Role Suspect Dosage Form TABLET Route Oral Dosing Frequency 1 Dosage forms Therapy Duration 1 every 1 Day(s) Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Cardiac arrest Chest pain MedDRA V16.0 Circulatory collapse MedDRA V16.0 Computerised tomogram abnormal MedDRA V16.0 Dyspnoea MedDRA V16.0 Pain in extremity MedDRA V16.0 Pulmonary embolism MedDRA V16.0 Page 8 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000333038 Version No. Initial Rec. Date Latest Rec. Date 3 2009-11-12 2009-12-31 Record Type Report Source MAH MAH Number 200938680NA Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Other Health Professional Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 15 Years Gender Female Height Weight Report Outcome Death Product Information Product Description Product Role YASMIN 28 Dosage Form Suspect Route TABLET Dosing 1 Dosage forms Oral Frequency Therapy Duration 1 every 1 Day(s) Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Pulmonary embolism Duration Report Information Aer No 000347628 Version No. Initial Rec. Date Latest Rec. Date 1 2010-07-19 2010-09-24 Record Type Report Source MAH MAH Number 201027827NA Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Physician Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 19 Years Gender Female Height Weight Report Outcome Death Product Information Product Description YASMIN 28 Product Role Suspect Dosage Form TABLET Route Dosing Frequency Therapy Duration Oral Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Pulmonary embolism Page 9 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000360420 Version No. Initial Rec. Date Latest Rec. Date 0 2011-01-25 2011-01-25 Record Type Report Source Hospital MAH Number 2011058892 Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Pharmacist Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 18 Years Gender Female Height 152 Centimetres Weight 80 Kilograms Report Outcome Death Product Information Product Description Product Role Dosage Form Route Dosing Frequency CONCERTA Suspect TABLET (EXTENDED-RELEASE) Oral 54 Milligram 1 every 1 Day(s) YASMIN 28 Suspect TABLET Oral 1 Dosage forms Therapy Duration 1 every 1 Day(s) Unknown MERREM Concomitant POWDER FOR SOLUTION INTRAVENOUS NIMBEX Concomitant LIQUID INTRAVENOUS Unknown PIPERACILLIN/TAZOBACTAM Concomitant NOT SPECIFIED Unknown PRECEDEX Concomitant SOLUTION INTRAVENOUS Unknown RANITIDINE Concomitant NOT SPECIFIED Unknown SENNOSIDES Concomitant NOT SPECIFIED Unknown VANCOMYCIN Concomitant NOT SPECIFIED Unknown Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Cerebral haemorrhage Cerebral venous thrombosis MedDRA V16.0 Page 10 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000364889 Version No. Initial Rec. Date Latest Rec. Date 1 2011-03-24 2011-04-07 Record Type Report Source MAH MAH Number 2011021636 Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Physician Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 19 Years Gender Female Height Weight Report Outcome Death Product Information Product Description Product Role YASMIN 21 Dosage Form Suspect Route TABLET Dosing Frequency Therapy Duration Unknown Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Intracranial aneurysm Duration Report Information Aer No 000389720 Version No. Initial Rec. Date Latest Rec. Date 0 2011-11-24 2011-11-24 Record Type Report Source MAH MAH Number 2011111177 Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Life Threatening: Reporter Type Physician Disability: Hospitalization: Congenital Anomaly: Yes Other Medically Imp Condition: Patient Information Age 40 Years Gender Female Height Weight Report Outcome Death Product Information Product Description YASMIN 21 Product Role Suspect Dosage Form TABLET Route Dosing Frequency Therapy Duration Unknown Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Ankle fracture Pulmonary embolism MedDRA V16.0 Page 11 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000446211 Version No. Initial Rec. Date Latest Rec. Date 0 2012-06-25 2012-06-25 Record Type Report Source MAH MAH Number 2012058576 Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Lawyer Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 15 Years Gender Female Height Weight Report Outcome Death Product Information Product Description Product Role YASMIN 21 Dosage Form Suspect Route TABLET Dosing Frequency Therapy Duration Unknown Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Syncope Duration Report Information Aer No 000461530 Version No. Initial Rec. Date Latest Rec. Date 0 2012-08-29 2012-08-29 Record Type Report Source MAH MAH Number CAJNJFOC20120812058( Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Type of Report Spontaneous Yes Reporter Type Consumer Or Other Non Health Professional Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 18 Years Gender Female Height Weight Report Outcome Death Product Information Product Description Product Role Dosage Form Route CONCERTA Suspect TABLET (EXTENDED-RELEASE) YASMIN 28 Suspect TABLET Dosing Frequency Therapy Duration Oral Unknown Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Cerebral venous thrombosis Page 12 of 14 Duration YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000497817 Version No. Initial Rec. Date Latest Rec. Date 0 2013-02-07 2013-02-07 Record Type Report Source Community MAH Number Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes Disability: Life Threatening: Yes No Duplicate or Linked Reports Reporter Type Consumer Or Other Non Health Professional Yes Hospitalization: Congenital Anomaly: Yes Other Medically Imp Condition: Patient Information Age 36 Years Gender Female Height 157 Centimetres Weight 300 Pounds Report Outcome Death Product Information Product Description Product Role YASMIN 28 Dosage Form Suspect Route TABLET Dosing Frequency 1 every 1 Day(s) Oral Therapy Duration 8 Week(s) Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Influenza Pulmonary embolism Duration MedDRA V16.0 Report Information Aer No 000499352 Version No. Initial Rec. Date Latest Rec. Date 0 2013-02-13 2013-02-13 Record Type Report Source Community MAH Number Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Consumer Or Other Non Health Professional Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age 36 Years Gender Female Height Weight 298 Pounds Report Outcome Death Product Information Product Description Product Role Dosage Form YASMIN 28 Suspect TABLET ELTROXIN Concomitant Route Oral Dosing Frequency Therapy Duration 1 Dosage forms 1 every 1 Day(s) 37 Day(s) TABLET Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Pulmonary embolism Page 13 of 14 Duration Yes YASMIN 28 YASMIN Report Runtime 2013-06-06 - YASMINPM 2:42:14 21 Health Product: YASMIN (DROSPIRENONE, ETHINYL ESTRADIOL/NORETHINDRONE OR PLACEBO, ETHINYL ESTRADIOL) YASMIN (DROSPIRENONE/ETHINYLESTRADIOL) 1965-01-01 to 2013-02-28 Initial date of receipt: YASMIN (DROSPIRENONE W/ ETHINYLESTRADIOL) Total Number of Reports: 18 Reports YASMIN (DROSPIRENONE W/ETHINYLESTRADIOL) Canada Vigilance Summary of Reported Adverse Reactions Report Information Aer No 000501984 Version No. Initial Rec. Date Latest Rec. Date 0 2013-02-14 2013-02-14 Record Type Report Source MAH MAH Number 2013013398 Type of Report Spontaneous Serious Report? Link Aer Number Death: Yes No Duplicate or Linked Reports Yes Reporter Type Consumer Or Other Non Health Professional Congenital Anomaly: Hospitalization: Life Threatening: Disability: Other Medically Imp Condition: Patient Information Age Gender Female Height Weight Report Outcome Death Product Information Product Description YASMIN 28 Product Role Suspect Dosage Form TABLET Route Dosing Frequency Therapy Duration Oral Reaction Information MedDRA Preferred Term MedDRA Version MedDRA V16.0 Pulmonary embolism Page 14 of 14 Duration