- 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 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
- 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 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
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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
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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
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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 Risperdal (risperidone) was introduced in the United Kingdom.
Answer
The firstRisperdal preparations (Risperdal 1, 2, 3 and 4mg tablets) were authorised in the UK on 8 December 1992.
- 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 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 how many doses of Ritalin (methylphenidate hydrochloride) have been prescribed to children since its introduction.
Answer
Information collatedcentrally by NHS National Services Scotland on prescribed doses of drugs is measuredusing the average maintenance dose of a drug as used in adults. This unit of measurementis based on advice from the World Health Organization. It is not possible to extractfrom that data the number of doses of Ritalin (methylphenidate hydrochloride) prescribedexclusively for children.NHS National Services Scotland website carries generalinformation about drugs used in the treatment of Attention Deficit HyperactivityDisorder (ADHD). This information can be found at
www.isdscotland.org.More generally, inrelation to the management of ADHD, NHS Quality Improvement Scotland is currentlyundertaking a national audit of the care and treatment provided throughout Scotland for children with ADHD, including the use of drug therapy.The report of this exercise is due to be published in March 2008.
- 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 there have been any cases of children suffering adverse or severe adverse effects from the use of the prescription drug Ritalin (methylphenidate 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 methyphendidate is 588. This figure includesreports 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.