| Product Quality Issue |
|
9/14/2008 |
58 |
Male |
|
12/19/2008 |
Consumer |
United States |
|
| Sinusitis |
Hospitalization |
1/1/2006 |
67 |
Female |
178 lb |
1/30/2009 |
Consumer |
United States |
|
| Liver Function Test Abnormal |
|
12/5/2008 |
|
Male |
|
2/24/2009 |
|
United States |
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
362 lb |
3/2/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
3/2/2009 |
Physician |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
362 lb |
3/5/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
3/9/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
|
|
|
3/9/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
10/10/2008 |
43 |
Female |
|
3/2/2009 |
Other Health Professional |
United Kingdom |
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
3/10/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
1/1/2008 |
43 |
Female |
362 lb |
3/16/2009 |
Consumer |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
|
|
|
3/26/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
10/10/2008 |
43 |
Female |
|
3/25/2009 |
Other Health Professional |
United Kingdom |
|
| Weight Increased |
Other Serious |
11/1/2008 |
|
Male |
210 lb |
4/21/2009 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Myalgia |
Disability |
3/1/2009 |
63 |
Male |
|
5/8/2009 |
Physician |
United States |
|
| Wheezing |
Hospitalization |
4/8/2009 |
|
|
176 lb |
5/15/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Headache |
Hospitalization |
2/25/2009 |
58 |
Male |
|
6/15/2009 |
Physician |
Italy |
|
| Wheezing |
Hospitalization |
4/8/2009 |
|
|
176 lb |
6/25/2009 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
1/1/2008 |
43 |
Female |
362 lb |
6/29/2009 |
Consumer |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
10/10/2008 |
43 |
Female |
360 lb |
7/13/2009 |
Physician |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
10/10/2008 |
43 |
Female |
360 lb |
7/16/2009 |
Physician |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Urticaria |
|
7/1/2009 |
|
Male |
220 lb |
8/29/2009 |
|
United States |
|
| Syncope |
Hospitalization |
|
45 |
Male |
213 lb |
8/28/2009 |
|
United States |
|
| Syncope |
Other Serious |
8/22/2009 |
|
Female |
145 lb |
9/11/2009 |
Other Health Professional |
United States |
|
| Syncope |
Hospitalization |
|
45 |
Male |
213 lb |
9/8/2009 |
|
United States |
|
| Palpitations |
Hospitalization |
|
78 |
Female |
|
9/16/2009 |
|
United States |
|
| Pulmonary Hypertension |
Hospitalization |
6/5/2007 |
44 |
Male |
213 lb |
9/18/2009 |
|
United States |
|
| Syncope |
Other Serious |
8/22/2009 |
|
Female |
145 lb |
9/30/2009 |
|
United States |
|
| Tricuspid Valve Disease |
Hospitalization |
6/5/2007 |
44 |
Male |
213 lb |
9/25/2009 |
|
United States |
|
| Quality Of Life Decreased |
Hospitalization |
|
78 |
Female |
|
9/25/2009 |
|
United States |
|
| Weight Increased |
Other Serious |
1/1/2008 |
43 |
Female |
362 lb |
10/22/2009 |
Consumer |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Tinnitus |
Other Serious |
1/1/2008 |
|
Female |
170 lb |
10/23/2009 |
Consumer |
United States |
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
11/3/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Quality Of Life Decreased |
Hospitalization |
|
78 |
Female |
|
10/26/2009 |
|
United States |
|
| Urinary Tract Infection |
Hospitalization |
7/23/2009 |
68 |
Female |
226 lb |
10/30/2009 |
Physician |
United States |
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
11/4/2009 |
|
|
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Other Serious |
1/1/2008 |
43 |
Female |
362 lb |
11/13/2009 |
Consumer |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Muscular Weakness |
|
12/1/2007 |
60 |
Female |
|
11/13/2009 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
11/16/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
11/23/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pruritus |
|
8/19/2009 |
|
Female |
215 lb |
11/25/2009 |
Consumer |
United States |
|
| Weight Increased |
Hospitalization |
5/1/2007 |
43 |
Female |
360 lb |
11/25/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
11/30/2009 |
Other Health Professional |
United Kingdom |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
1/1/2008 |
43 |
Female |
360 lb |
11/30/2009 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Muscle Spasms |
Other Serious |
|
|
Male |
|
12/1/2009 |
|
United States |
|
| Pain In Extremity |
Other Serious |
10/10/2009 |
|
Female |
|
12/1/2009 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Weight Increased |
Hospitalization |
10/10/2008 |
43 |
Female |
|
11/23/2009 |
Other Health Professional |
United Kingdom |
|
| Unevaluable Event |
Hospitalization |
1/25/2008 |
56 |
Male |
|
11/20/2009 |
|
United States |
|
| Vomiting |
Hospitalization |
7/23/2009 |
68 |
Female |
226 lb |
11/25/2009 |
Physician |
United States |
|
| Tachycardia |
Hospitalization |
1/25/2008 |
56 |
Male |
|
12/1/2009 |
|
United States |
|
| Somnolence |
Hospitalization |
1/1/2005 |
|
Female |
173 lb |
12/11/2009 |
Consumer |
United States |
|
| Thought Broadcasting |
|
1/1/2009 |
47 |
Female |
112 lb |
12/9/2009 |
Consumer |
United States |
|
| Tachycardia |
Hospitalization |
1/25/2008 |
56 |
Male |
|
12/11/2009 |
|
United States |
|
| Intervertebral Disc Protrusion |
Disability |
|
|
|
|
12/18/2009 |
Consumer |
United States |
|
| Rash Erythematous |
|
3/9/2009 |
48 |
Male |
|
1/4/2010 |
Consumer |
United States |
|
| Product Quality Issue |
|
3/16/2009 |
71 |
Male |
|
1/4/2010 |
Consumer |
United States |
|
| Neutropenia |
Life Threatening |
12/14/2009 |
|
Male |
184 lb |
1/20/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Treatment Noncompliance |
Hospitalization |
12/1/2009 |
|
Male |
292 lb |
2/5/2010 |
|
United States |
|
| Neutropenia |
Other Serious |
12/14/2009 |
|
Male |
184 lb |
2/9/2010 |
|
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Other Serious |
1/1/2005 |
|
Male |
980 lb |
2/8/2010 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Treatment Noncompliance |
Hospitalization |
12/1/2009 |
|
Male |
292 lb |
2/22/2010 |
|
United States |
|
| Vomiting |
Other Serious |
1/1/2005 |
|
Male |
980 lb |
2/23/2010 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Vomiting |
Other Serious |
1/1/2005 |
|
Male |
980 lb |
3/1/2010 |
Pharmacist |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Syncope |
Other Serious |
5/1/2006 |
|
Female |
206 lb |
3/17/2010 |
Physician |
United States |
|
| Myalgia |
Other Serious |
|
85 |
Male |
|
4/5/2010 |
Consumer |
United States |
|
| Unresponsive To Stimuli |
Other Serious |
1/28/2008 |
48 |
Female |
|
5/24/2010 |
Lawyer |
United States |
|
| Ventricular Tachycardia |
Other Serious |
|
76 |
Male |
|
5/18/2010 |
|
United States |
|
| Syncope |
Other Serious |
5/1/2006 |
36 |
Female |
206 lb |
6/29/2010 |
Physician |
United States |
|
| Oxygen Saturation Decreased |
Hospitalization |
6/19/2010 |
82 |
Female |
114 lb |
7/9/2010 |
Consumer |
United States |
|
| Oxygen Saturation Decreased |
Hospitalization |
6/19/2010 |
82 |
Female |
114 lb |
7/14/2010 |
Physician |
United States |
|
| Product Substitution Issue |
Required Intervention |
6/14/2010 |
53 |
Female |
250 lb |
7/12/2010 |
|
United States |
|
| Unresponsive To Stimuli |
Other Serious |
1/28/2008 |
48 |
Female |
|
7/22/2010 |
Lawyer |
United States |
|
| Wound Infection Staphylococcal |
Hospitalization |
9/1/2007 |
74 |
Female |
|
7/27/2010 |
Consumer |
|
|
| Ventricular Tachycardia |
Other Serious |
|
76 |
Male |
|
7/26/2010 |
|
United States |
|
| Syncope |
Other Serious |
5/1/2006 |
36 |
Female |
206 lb |
8/17/2010 |
Physician |
United States |
|
| Paraesthesia |
|
1/1/2009 |
57 |
Male |
282 lb |
8/28/2010 |
Consumer |
United States |
|
| Urine Colour Abnormal |
|
|
|
Female |
150 lb |
8/28/2010 |
|
United States |
|
| Flushing |
|
|
|
Male |
220 lb |
8/28/2010 |
|
United States |
|
| Paraesthesia |
|
4/21/2010 |
61 |
Female |
278 lb |
8/29/2010 |
Consumer |
United States |
|
| Pruritus |
|
4/23/2010 |
28 |
Female |
206 lb |
8/29/2010 |
|
United States |
|
| Pruritus |
|
|
|
Male |
227 lb |
8/29/2010 |
Consumer |
United States |
|
| International Normalised Ratio Increased |
Required Intervention |
6/14/2010 |
53 |
Female |
250 lb |
8/27/2010 |
|
United States |
|
| Unresponsive To Stimuli |
Other Serious |
1/28/2008 |
48 |
Female |
309 lb |
9/28/2010 |
Lawyer |
United States |
|
| Proteinuria |
Other Serious |
8/11/2010 |
55 |
Female |
|
10/8/2010 |
Other Health Professional |
Brazil |
|
| Pleural Effusion |
Other Serious |
1/1/2006 |
42 |
Female |
190 lb |
10/13/2010 |
Consumer |
United States |
|
| Weight Decreased |
Other Serious |
3/6/2008 |
55 |
Female |
165 lb |
10/19/2010 |
Other Health Professional |
Brazil |
|
| Death |
Death |
|
|
Female |
145 lb |
10/19/2010 |
Consumer |
United States |
|
| Ventricular Hypertrophy |
Hospitalization |
|
70 |
Male |
|
10/21/2010 |
|
United States |
|
| Proteinuria |
Other Serious |
8/11/2010 |
55 |
Female |
|
11/3/2010 |
Other Health Professional |
Brazil |
|
| Urinary Tract Infection |
Hospitalization |
1/29/2010 |
83 |
Male |
182 lb |
10/27/2010 |
Physician |
United States |
|
| Gastrointestinal Haemorrhage |
Hospitalization |
10/28/2010 |
69 |
Male |
|
11/11/2010 |
Physician |
United States |
|
| Fatigue |
|
|
58 |
Male |
|
11/11/2010 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pleural Effusion |
Other Serious |
1/1/2006 |
42 |
Female |
190 lb |
11/16/2010 |
Physician |
United States |
|
| Electrolyte Imbalance |
Other Serious |
11/23/2010 |
|
Female |
|
12/3/2010 |
Physician |
United States |
|
| Tooth Fracture |
|
7/1/2010 |
|
|
|
12/23/2010 |
Physician |
United States |
|
| Unresponsive To Stimuli |
Other Serious |
1/28/2008 |
48 |
Female |
309 lb |
1/6/2011 |
Other Health Professional |
United States |
|
| Drug Administration Error |
|
|
80 |
Female |
|
1/7/2011 |
Consumer |
United States |
|
| Product Quality Issue |
|
|
72 |
Female |
|
1/7/2011 |
Consumer |
United States |
|
| Drug Ineffective |
|
|
73 |
Female |
|
1/7/2011 |
Consumer |
United States |
|
| Electrolyte Imbalance |
Other Serious |
11/23/2010 |
62 |
Female |
|
1/18/2011 |
Physician |
United States |
|
| Dyspnoea |
Other Serious |
1/1/2006 |
42 |
Female |
190 lb |
1/27/2011 |
Physician |
United States |
|
| Pain |
|
|
|
Female |
160 lb |
1/29/2011 |
Other Health Professional |
United States |
|
| Congenital Aortic Valve Incompetence |
Hospitalization |
1/1/2005 |
50 |
Female |
258 lb |
2/9/2011 |
Consumer |
United States |
|
| Silent Myocardial Infarction |
Other Serious |
1/1/2005 |
50 |
Female |
258 lb |
2/9/2011 |
Consumer |
United States |
|
| Dizziness |
|
|
79 |
Male |
|
2/28/2011 |
Consumer |
United States |
|
| Death |
Death |
|
79 |
Female |
|
4/26/2011 |
Other Health Professional |
United States |
|
| Pain In Jaw |
|
|
53 |
Female |
117 lb |
5/19/2011 |
Pharmacist |
United States |
|
| Dyspnoea |
Hospitalization |
5/28/2011 |
58 |
Male |
|
6/10/2011 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Pneumonia |
|
|
72 |
Female |
|
6/21/2011 |
|
United States |
|
| Capillary Fragility |
|
6/1/2011 |
72 |
Male |
|
7/1/2011 |
Consumer |
United States |
|
| Off Label Use |
Hospitalization |
|
|
Male |
255 lb |
7/7/2011 |
Consumer |
United States |
|
| Blood Triglycerides Increased |
Hospitalization |
1/1/2010 |
67 |
Male |
240 lb |
7/22/2011 |
Consumer |
United States |
|
| Dizziness |
|
|
80 |
Female |
|
7/25/2011 |
Consumer |
United States |
|
| Sleep Disorder |
|
|
|
Male |
220 lb |
8/5/2011 |
Consumer |
United States |
|
| Blood Glucose Increased |
Other Serious |
8/17/2010 |
56 |
Female |
228 lb |
8/5/2011 |
Physician |
United States |
|
| Paraesthesia |
|
6/1/2011 |
57 |
Female |
|
8/6/2011 |
Consumer |
United States |
|
| Flushing |
|
|
|
Female |
205 lb |
8/6/2011 |
Consumer |
United States |
|
| Blood Glucose Increased |
|
7/1/2011 |
56 |
Female |
210 lb |
8/6/2011 |
Consumer |
United States |
|
| Feeling Hot |
|
|
|
Male |
200 lb |
8/6/2011 |
Consumer |
United States |
|
| Flushing |
|
|
|
Male |
175 lb |
8/6/2011 |
Consumer |
United States |
|
| Weight Decreased |
Other Serious |
|
|
Female |
|
8/10/2011 |
Consumer |
United States |
|
| Oedema Peripheral |
Other Serious |
|
47 |
Female |
|
8/22/2011 |
Consumer |
United States |
|
| Nausea |
|
8/1/2011 |
69 |
Male |
|
8/23/2011 |
Consumer |
United States |
|
| Blindness |
Other Serious |
5/1/2011 |
97 |
Female |
|
9/20/2011 |
Consumer |
United States |
|
| Cardiac Failure Congestive |
Other Serious |
|
47 |
Female |
|
10/13/2011 |
Consumer |
United States |
|
| Papule |
Other Serious |
1/19/2009 |
52 |
Female |
213 lb |
10/14/2011 |
Physician |
United States |
|
| Ischaemic Stroke |
Life Threatening |
10/21/2011 |
53 |
Male |
302 lb |
10/27/2011 |
Pharmacist |
United States |
|
| Sleep Apnoea Syndrome |
Disability |
|
56 |
Male |
280 lb |
11/16/2011 |
Lawyer |
United States |
|
| Blindness |
Other Serious |
5/1/2011 |
97 |
Female |
|
12/7/2011 |
Consumer |
United States |
|
| Blood Creatine Phosphokinase Increased |
Other Serious |
1/1/2009 |
57 |
Male |
|
12/14/2011 |
Physician |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Ineffective |
|
|
84 |
Female |
|
12/20/2011 |
Consumer |
United States |
|
| Therapeutic Response Unexpected |
|
|
46 |
Female |
|
12/20/2011 |
Consumer |
United States |
|
| Therapeutic Response Unexpected |
|
4/1/2011 |
68 |
Male |
|
12/20/2011 |
Consumer |
United States |
|
| Renal Failure |
Other Serious |
|
63 |
|
|
12/30/2011 |
Consumer |
United States |
|
| Off Label Use |
Hospitalization |
|
|
Male |
255 lb |
11/17/2011 |
Lawyer |
United States |
|
| Multiple Myeloma |
Other Serious |
1/1/2009 |
57 |
Male |
|
1/9/2012 |
Other Health Professional |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Cough |
Other Serious |
1/6/2012 |
64 |
Male |
|
1/13/2012 |
|
United States |
|
| Nausea |
|
5/1/2011 |
63 |
Female |
|
1/28/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Drug Dose Omission |
|
10/1/2010 |
48 |
Female |
|
1/27/2012 |
Consumer |
United States |
|
| Injection Site Pain |
Other Serious |
|
41 |
Female |
|
1/28/2012 |
Consumer |
United States |
|
| Drug Intolerance |
Other Serious |
11/14/2011 |
83 |
Female |
170 lb |
2/14/2012 |
Consumer |
United States |
|
| Cardiac Failure Congestive |
Hospitalization |
1/16/2012 |
57 |
Female |
230 lb |
2/14/2012 |
Other Health Professional |
United States |
|
| Cough |
Other Serious |
1/6/2012 |
64 |
Male |
|
2/20/2012 |
Physician |
United States |
|
| Death |
Death |
11/6/2011 |
48 |
Female |
|
2/24/2012 |
Physician |
United States |
|
| Pain |
Other Serious |
7/14/2011 |
70 |
Female |
|
3/4/2012 |
Consumer |
United States |
|
| Azotaemia |
Hospitalization |
3/1/2012 |
85 |
Female |
|
3/8/2012 |
Pharmacist |
United States |
|
| Tenderness |
Other Serious |
2/1/2012 |
64 |
Female |
157 lb |
2/24/2012 |
Pharmacist |
United States |
|
| White Blood Cell Count Increased |
Other Serious |
11/14/2011 |
83 |
Female |
170 lb |
3/13/2012 |
Physician |
United States |
|
| Facial Bones Fracture |
Other Serious |
1/1/2011 |
69 |
Female |
|
3/13/2012 |
Consumer |
United States |
| Primary |
|
| Secondary |
|
| Concomitant |
|
|
| Gastrooesophageal Reflux Disease |
Disability |
|
78 |
Female |
140 lb |
3/19/2012 |
Lawyer |
United States |
|