Instances of death in connection with Strattera treatment

Instances of death in connection with Strattera treatment

Children-Adolescents:

20 suicides reported to FDA 2004-2008 (September)

(Strattera reported as Primary Suspect Drug, PS)

9 Years M 6079094 LW 9 Years M 6237403 MD 10 Years M 5983572 MD 12 Years M 5910416 MD 12 Years M 6370501 CN 14 Years M 5913951 MD 14 Years M 6183286 CN 14 Years M 6315638 MD 14 Years M 6617515 MD 15 Years M 5671703 MD 15 Years M 5952177 MD 16 Years M 5951902 OT

16 Years 6322828 CN 16 Years M 6393534 MD 17 Years M 4152711 MD 17 Years M 5738728 MD 17 Years M 5924684 18 Years M 4168987 MD 18 Years M 6026869 CN 19 Years F 5923694 MD

+18 instances of death not from suicide, FDA 2004-2008

(Strattera reported as Primary Suspect Drug)

3 Years F 6355915 MD 5 Years M 5882337 MD 5 Years M 4112478 MD 5 Years M 6102860 MD 6 Years M 5876785 MD 7 Years M 5890841 MD 8 Years M 4199197 MD 10 Years M 6109466 MD 11 Years F 6014130 11 Years M 5754653 MD

12 Years 6042142 MD 12 Years M 4041277 MD

12 Years 6447235 MD

14 Years 5923700 MD 16 Years M 3970831 MD

Summary children and adolescents: 20+18= 38 reported dead in FDA 2004-2008 (with Strattera as Primary Suspect Drug,

30 of these reports by Health Care Professionals, HCPs).

Adults:

+20 suicides reported to FDA 2004-2008

(Strattera reported as Primary Suspect Drug)

20 Years F 5796217 OT 21 Years M 6054812 PH 21 Years M 6157560 25 Years M 6440228 MD 27 Years M 5899462 MD 28 Years M 6183275 CN 33 Years F 6373005 35 Years F 4101722 MD 35 Years M 4141401 MD 35 Years F 6571904 CN 39 Years M 5744981 MD M 5897087 M 5919125 M 5939430 M 6168850 MD M 6371858 MD M 6579175 MD M 6731814 CN 32 Years F 5651144 MD 47 Years M 5655897 MD

(The last two cases confirmed as fatal suicide cases in Lilly’s reports to the MHRA)

+22 instances of death, not from suicide, FDA 2004-2008

(Strattera reported as Primary Suspect Drug)

20 Years M 6164621 CN 26 Years M 5731386 MD 27 Years F 5996604 MD 33 Years M 6076514 MD 41 Years M 4157588 MD 42 Years M 6353706 MD 42 Years M 5658262 MD 45 Years F 4148360 MD

47 Years F 5655897 MD

50 Years F 6234939 MD 65 Years F 5862506 MD 71 Years M 5769652 MD 76 Years M 6353706 MD F 6043198 MD M 6014238 MD F 6508341 CN F 5764249 MD M 6551202 MD F 6610971 MD M 6642208 MD

+ 7 stillbirth/abortion spontaneous FDA 2004-2008

(Strattera reported as Primary Suspect Drug)

Abortion F 4205958 Spontaneous Abortion

22 F 5752581 OT Spontaneous Abortion

25 F 6384021 CN Spontaneous Abortion

38 F 5752476 CN Spontaneous Abortion 4148345 MD Induced

Summary adults, stillbirth/abortion spontaneous: 20+22+7= 49 reported dead in FDA 2004-2008 (with Strattera

as Primary Suspect Drug) (at least 32 of these reports by HCPs.)

SUMMARY OF FDA 2004-2008 – Strattera as PS: 38 children and adolescents + 42 adults + 7 stillbirth/abortion spontaneous = 87 deaths

(At least 62 of these reports by HCPs.)

In addition the following fatal cases in connection with Strattera treatment – with Strattera as Secondary Suspect Drug (SS) or with concomitant drugs (C) – are reported to FDA 2004-2008:

Children-Adolescents: 4 additional suicides

18 Years F 6169250 OT 18 Years F 6191766 OT 19 Years M 6524629 OT 19 Years M 6558554 OT

3 additional deaths

12 Years F 5778437 MD

14 Years 5891395 PH 17 Years M 5737094 CN

Adults: 8 additional suicides

20 Years M 6096346 CN 21 Years F 6385870 CN 26 Years M 4210354 CN 41 Years F 5738584 MD 50 Years F 4220166 MD 59 Years M 4112662 LW M 5701390 CN M 6516259 OT

7 additional deaths

38 Years F 6229654 OT 44 Years M 6296730 OT 45 Years F 4201758 MD 46 Years M 6106576 MD 48 Years M 6169382 50 Years F 6238431 CN F 5905025 MD

+ 1 stillbirth/abortion spontaneous FDA 2004-2008

Abortion 5788809 Spontaneous OT

SUMMARY FROM FDA 2004-2008 including Strattera in all Role Codes (PS, SS, C): 24 (suicides) + 21 = 45 children and adolescents; 28 (suicides) + 29 = 57 adults + 8 stillbirth/abortion spontaneous

= 110 reported cases of death to FDA

Added to this from Periodic Safety Update Reports (PSURs) and Risk/Benefit Report from 2006.

(The cases below are clearly not part of the reports submitted to FDA There are most likely also other fatal cases described by Lilly in different PSURs to MHRA, which are not part of the FDA data. Theses cases are not included here.) 2 years (F) “The third case involved a 2-year-old who was taking both atomoxetine and olanzapine at high doses at the time of her death.” (sic!) PSUR 9 13 years (M) suicide PSUR 9 16 years (M) “liver congestion consistent with dilated cardiomyopathy” Risk/Benefit Assessment Report January 2006 45 years (M) “cardiomegaly” Risk/Benefit Assessment Report January 2006 67 years (F) sudden death PSUR 9

In total 48 children and adolescents, 59 adults, 8 stillbirth/abortion spontaneous = 115 reported cases of death