10220DEATHS DUE TO ZYPREXA AND RISPERDAL - Australia

[Guest guest]

source -

http://forum.onlineopinion.com.au/thread.asp?article=11394 & page=0

"Question asked on 13 May 2010 (session 54-1) and published in Questions & Answers Paper No. 197 http://bulletin/prod/la/lapaper.nsf/V3QnBySN/541~197/$file/197-QA-S.pdf

Answer received on 17 June 2010 and printed in Questions & Answers Paper No. 211 http://bulletin/prod/la/lapaper.nsf/V3QnBySN/541~211/$file/211-QA-S.pdf .

10220DEATHS DUE TO ZYPREXA AND RISPERDALMr Daryl Maguire to the Deputy Premier, and Minister for Health

1. Is the Minister aware that in Zyprexa and Risperdal clinical trials presented to the US FDA to get these drugs licensed, it was revealed that: 1. 1 in 208 (20) Zyprexa (olanzapine) subjects died; 2. 1 in 250 (12) risperidone clinical trial subjects died; 3. most of the deaths (21) were suicides?

2. Is the Minister aware of damages being paid to States and individuals consequent on litigation for fraudulent promotion of medication?

3. Is the Minister aware that by 2003, 288 deaths had been reported to the TGA of persons taking new "Atypical" drugs?

4. What warnings have been issued to patients and prescribers re the above drugs?

5. (a) Have these deaths been thoroughly investigated by coroners as they are in the USA, as described in the editorial provided to which an Australian (NSW) psychiatrist has contributed?

6. ( Has an inquiry been made into what medications they were taking or had recently taken? AnswerI am advised:(1) and (2) Agreement for drugs to be included for Australian use rests with the Commonwealth Government. The Therapeutic Goods Administration (TGA) regularly evaluates prescription medicines for quality and safety and to ensure that the product is effective for its intended use. NSW Health ensures that any warnings issued by the TGA are included in relevant clinical guidelines.(3) The TGA's Office of Medicines Safety Monitoring receives reports of suspected adverse reactions to prescribed medicines, vaccines, over-the-counter medicines and complementary medicines.(4) The TGA provides advice on suspected adverse reactions to prescription medicines to the public and prescribers as required. Information is available to patients and prescribers in the Approved Product Information leaflets on medicines approved in Australia.(5) Questions concerning the Coronial Process should be directed to the NSW Attorney General."

[Guest guest]

source -

http://forum.onlineopinion.com.au/thread.asp?article=11394 & page=0

"Question asked on 13 May 2010 (session 54-1) and published in Questions & Answers Paper No. 197 http://bulletin/prod/la/lapaper.nsf/V3QnBySN/541~197/$file/197-QA-S.pdf

Answer received on 17 June 2010 and printed in Questions & Answers Paper No. 211 http://bulletin/prod/la/lapaper.nsf/V3QnBySN/541~211/$file/211-QA-S.pdf .

10220DEATHS DUE TO ZYPREXA AND RISPERDALMr Daryl Maguire to the Deputy Premier, and Minister for Health

1. Is the Minister aware that in Zyprexa and Risperdal clinical trials presented to the US FDA to get these drugs licensed, it was revealed that: 1. 1 in 208 (20) Zyprexa (olanzapine) subjects died; 2. 1 in 250 (12) risperidone clinical trial subjects died; 3. most of the deaths (21) were suicides?

2. Is the Minister aware of damages being paid to States and individuals consequent on litigation for fraudulent promotion of medication?

3. Is the Minister aware that by 2003, 288 deaths had been reported to the TGA of persons taking new "Atypical" drugs?

4. What warnings have been issued to patients and prescribers re the above drugs?

5. (a) Have these deaths been thoroughly investigated by coroners as they are in the USA, as described in the editorial provided to which an Australian (NSW) psychiatrist has contributed?

6. ( Has an inquiry been made into what medications they were taking or had recently taken? AnswerI am advised:(1) and (2) Agreement for drugs to be included for Australian use rests with the Commonwealth Government. The Therapeutic Goods Administration (TGA) regularly evaluates prescription medicines for quality and safety and to ensure that the product is effective for its intended use. NSW Health ensures that any warnings issued by the TGA are included in relevant clinical guidelines.(3) The TGA's Office of Medicines Safety Monitoring receives reports of suspected adverse reactions to prescribed medicines, vaccines, over-the-counter medicines and complementary medicines.(4) The TGA provides advice on suspected adverse reactions to prescription medicines to the public and prescribers as required. Information is available to patients and prescribers in the Approved Product Information leaflets on medicines approved in Australia.(5) Questions concerning the Coronial Process should be directed to the NSW Attorney General."

[Guest guest]

source -

http://forum.onlineopinion.com.au/thread.asp?article=11394 & page=0

"Question asked on 13 May 2010 (session 54-1) and published in Questions & Answers Paper No. 197 http://bulletin/prod/la/lapaper.nsf/V3QnBySN/541~197/$file/197-QA-S.pdf

Answer received on 17 June 2010 and printed in Questions & Answers Paper No. 211 http://bulletin/prod/la/lapaper.nsf/V3QnBySN/541~211/$file/211-QA-S.pdf .

10220DEATHS DUE TO ZYPREXA AND RISPERDALMr Daryl Maguire to the Deputy Premier, and Minister for Health

1. Is the Minister aware that in Zyprexa and Risperdal clinical trials presented to the US FDA to get these drugs licensed, it was revealed that: 1. 1 in 208 (20) Zyprexa (olanzapine) subjects died; 2. 1 in 250 (12) risperidone clinical trial subjects died; 3. most of the deaths (21) were suicides?

2. Is the Minister aware of damages being paid to States and individuals consequent on litigation for fraudulent promotion of medication?

3. Is the Minister aware that by 2003, 288 deaths had been reported to the TGA of persons taking new "Atypical" drugs?

4. What warnings have been issued to patients and prescribers re the above drugs?

5. (a) Have these deaths been thoroughly investigated by coroners as they are in the USA, as described in the editorial provided to which an Australian (NSW) psychiatrist has contributed?

6. ( Has an inquiry been made into what medications they were taking or had recently taken? AnswerI am advised:(1) and (2) Agreement for drugs to be included for Australian use rests with the Commonwealth Government. The Therapeutic Goods Administration (TGA) regularly evaluates prescription medicines for quality and safety and to ensure that the product is effective for its intended use. NSW Health ensures that any warnings issued by the TGA are included in relevant clinical guidelines.(3) The TGA's Office of Medicines Safety Monitoring receives reports of suspected adverse reactions to prescribed medicines, vaccines, over-the-counter medicines and complementary medicines.(4) The TGA provides advice on suspected adverse reactions to prescription medicines to the public and prescribers as required. Information is available to patients and prescribers in the Approved Product Information leaflets on medicines approved in Australia.(5) Questions concerning the Coronial Process should be directed to the NSW Attorney General."

[Guest guest]

source -

http://forum.onlineopinion.com.au/thread.asp?article=11394 & page=0

"Question asked on 13 May 2010 (session 54-1) and published in Questions & Answers Paper No. 197 http://bulletin/prod/la/lapaper.nsf/V3QnBySN/541~197/$file/197-QA-S.pdf

Answer received on 17 June 2010 and printed in Questions & Answers Paper No. 211 http://bulletin/prod/la/lapaper.nsf/V3QnBySN/541~211/$file/211-QA-S.pdf .

10220DEATHS DUE TO ZYPREXA AND RISPERDALMr Daryl Maguire to the Deputy Premier, and Minister for Health

1. Is the Minister aware that in Zyprexa and Risperdal clinical trials presented to the US FDA to get these drugs licensed, it was revealed that: 1. 1 in 208 (20) Zyprexa (olanzapine) subjects died; 2. 1 in 250 (12) risperidone clinical trial subjects died; 3. most of the deaths (21) were suicides?

2. Is the Minister aware of damages being paid to States and individuals consequent on litigation for fraudulent promotion of medication?

3. Is the Minister aware that by 2003, 288 deaths had been reported to the TGA of persons taking new "Atypical" drugs?

4. What warnings have been issued to patients and prescribers re the above drugs?

5. (a) Have these deaths been thoroughly investigated by coroners as they are in the USA, as described in the editorial provided to which an Australian (NSW) psychiatrist has contributed?

6. ( Has an inquiry been made into what medications they were taking or had recently taken? AnswerI am advised:(1) and (2) Agreement for drugs to be included for Australian use rests with the Commonwealth Government. The Therapeutic Goods Administration (TGA) regularly evaluates prescription medicines for quality and safety and to ensure that the product is effective for its intended use. NSW Health ensures that any warnings issued by the TGA are included in relevant clinical guidelines.(3) The TGA's Office of Medicines Safety Monitoring receives reports of suspected adverse reactions to prescribed medicines, vaccines, over-the-counter medicines and complementary medicines.(4) The TGA provides advice on suspected adverse reactions to prescription medicines to the public and prescribers as required. Information is available to patients and prescribers in the Approved Product Information leaflets on medicines approved in Australia.(5) Questions concerning the Coronial Process should be directed to the NSW Attorney General."