- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
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Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive in what year the prescription drug Efexor XL (venlafaxine hydrochloride) was introduced in the United Kingdom.
Answer
Efexor and Efexor XL are brand names of the drug substance venlafaxine hydrochloride.Venlafaxine has been licensedin the UK since November 1994 and Efexor XL, the modified release form of the drug,was first authorised in August 1997.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
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Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive how many doses of Efexor XL (venlafaxine hydrochloride) have been prescribed to children since its introduction.
Answer
It is not possibleto extract from prescription data collated centrally by NHS National Services Scotlandthe number of doses of venlafaxine hydrochloride prescribed exclusively for children.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
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Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive how many doses of Risperdal (risperidone) have been prescribed to children since its introduction.
Answer
It is not possibleto extract from prescription data collated centrally by NHS National Services Scotlandthe number of doses of Risperdal (risperidone) prescribed exclusively for children.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
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Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive whether there have been any cases of children suffering adverse or severe adverse effects from the use of the prescription drug Risperdal (risperidone) since its introduction and, if so, how many such cases have been reported.
Answer
The safety ofmedicines is reserved and is the responsibility of the Medicines and Healthcareproducts Regulatory Agency (MHRA). Reports of suspected adverse drug reactions (ADRs) are collected by theMHRA and Commission for Human Medicines (CHM) through the spontaneous reportingscheme, the Yellow Card Scheme. The safety of all marketed drugs is continuallymonitored by the MHRA and CHM. The MHRA has provided the following information:
The number ofsuspected ADR reports received by the MHRA for children aged 0-17 years from 1 July 1963 (when the Yellow Card Scheme was introduced) to 15 June 2007 inclusive for Risperdal (risperidone) is 190. Thisfigure includes reports received from the whole of the UK.
It is importantto note that the submission of a suspected ADR report does not necessarily meanthat it was caused by the drug. Many factors have to be taken into account inassessing causal relationships including temporal association, the possiblecontribution of concomitant medication and the underlying disease. Additionally,the use of medicines may vary between different age groups.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
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Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive whether any child deaths have been reported as a result of the administration of the prescription drug Ritalin (methylphenidate hydrochloride).
Answer
The safety ofmedicines is reserved and is the responsibility of the Medicines and Healthcareproducts Regulatory Agency (MHRA). Reports of suspected adverse drug reactions (ADRs) are collected by theMHRA and Commission for Human Medicines (CHM) through the spontaneous reportingscheme, the Yellow Card Scheme. The safety of all marketed drugs is continuallymonitored by the MHRA and CHM. The MHRA has provided the following information:
The number ofsuspected fatal ADR reports received by the MHRA for children aged 0-17 yearsfrom 1 July 1963 (when the Yellow Card Scheme was introduced) to 15 June 2007inclusive for methyphendidate is nine. This figure includes reports receivedfrom the whole of the UK.
It is importantto note that the submission of a suspected ADR report does not necessarily meanthat it was caused by the drug. Many factors have to be taken into account inassessing causal relationships including temporal association, the possiblecontribution of concomitant medication and the underlying disease. Additionally,the use of medicines may vary between different age groups.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
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Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive whether the prescription drug Efexor XL (venlafaxine hydrochloride) is licensed for use on children.
Answer
Efexor XL (venlafaxinehydrochloride) is not licensed for use in children and adolescents under the ageof 18 years. However, clinicianscan use drugs off-license i.e. outside their licensed indications, if they considerthat treatment to be the most appropriate for an individual patient. In these circumstancesthe clinician takes personal responsibility for the use of the drug.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
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Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive whether there have been any cases of children suffering adverse or severe adverse effects from the use of the prescription drug Efexor XL (venlafaxine hydrochloride) since its introduction and, if so, how many such cases have been reported.
Answer
The safety of medicinesis reserved and is the responsibility of the Medicines and Healthcare products RegulatoryAgency (MHRA). Reports of suspectedadverse drug reactions (ADRs) are collected by the MHRA and Commission for HumanMedicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme.The safety of all marketed drugs is continually monitored by the MHRA and CHM. TheMHRA has provided the following information:
The number of suspectedADR reports received by the MHRA for children aged 0-17 years from 1 July 1963 (when the Yellow Card Scheme was introduced) to 15 June 2007 inclusive for venlafaxine which includes Efexor XL is92. This figure includes reports received from the whole of the UK.
It is important tonote that the submission of a suspected ADR report does not necessarily mean thatit was caused by the drug. Many factors have to be taken into account in assessingcausal relationships including temporal association, the possible contribution ofconcomitant medication and the underlying disease. Additionally, the use of medicinesmay vary between different age groups.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
-
Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive whether any child deaths have been reported as a result of the administration of the prescription drug Risperdal (risperidone).
Answer
The safety of medicinesis reserved and is the responsibility of the Medicines and Healthcare products RegulatoryAgency (MHRA). Reports of suspectedadverse drug reactions (ADRs) are collected by the MHRA and Commission for HumanMedicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme.The safety of all marketed drugs is continually monitored by the MHRA and CHM. TheMHRA has provided the following information:
The number of suspectedfatal ADR reports received by the MHRA for children aged 0-17 years from 1 July 1963 (when the Yellow Card Scheme was introduced) to 15 June 2007 inclusive for Risperdal (risperidone) is two. This figureincludes reports received from the whole of the UK.
It is important tonote that the submission of a suspected ADR report does not necessarily mean thatit was caused by the drug. Many factors have to be taken into account in assessingcausal relationships including temporal association, the possible contribution ofconcomitant medication and the underlying disease. Additionally, the use of medicinesmay vary between different age groups.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
-
Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive whether the prescription drug Ritalin (methylphenidate hydrochloride) is licensed for use on children.
Answer
Ritalin(methylphenidate hydrochloride) is licensed for use in children aged six yearsand over as part of acomprehensive treatment programme for attention deficit hyperactivity disorder(ADHD). Treatment should be under the supervision of a specialist in childhoodbehavioural disorders.
- Asked by: Murdo Fraser, MSP for Mid Scotland and Fife, Scottish Conservative and Unionist Party
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Date lodged: Thursday, 14 June 2007
-
Current Status:
Answered by Shona Robison on 27 June 2007
To ask the Scottish Executive whether any child deaths have been reported as a result of the administration of the prescription drug Efexor XL (venlafaxine hydrochloride).
Answer
The safety of medicinesis reserved and is the responsibility of the Medicines and Healthcare products RegulatoryAgency (MHRA). Reports of suspectedadverse drug reactions (ADRs) are collected by the MHRA and Commission for HumanMedicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme.The safety of all marketed drugs is continually monitored by the MHRA and CHM. TheMHRA has provided the following information:
The number of suspectedfatal ADR reports received by the MHRA for children aged 0-17 years from 1 July 1963 (when the Yellow Card Scheme was introduced) to 15 June 2007 inclusive for venlafaxine which includes Efexor XL istwo. This figure includes reports received from the whole of the UK.
It is important tonote that the submission of a suspected ADR report does not necessarily mean thatit was caused by the drug. Many factors have to be taken into account in assessingcausal relationships including temporal association, the possible contribution ofconcomitant medication and the underlying disease. Additionally, the use of medicinesmay vary between different age groups
