- Asked by: Nicola Sturgeon, MSP for Glasgow, Scottish National Party
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Date lodged: Tuesday, 11 December 2001
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Current Status:
Answered by Malcolm Chisholm on 25 December 2001
To ask the Scottish Executive what representations it has made to Her Majesty's Government about improving the warning of side effects on the label carried by the acne drug Isotretinoin for the benefit of GPs and patients and, if it has not, whether it will make such representations
Answer
The Executive has not made any such representations and has no plans to do so.The Medicines Control Agency continuously monitors the safety of all medicines. If new side effects are detected, the product information is updated to ensure it contains all of the available information to aid the safe use of the medicine. The adverse reactions known to be associated with Roaccutane treatment are fully described in the product information, which consists of a Summary of Product Characteristic for healthcare professionals and a Patient Information Leaflet for patients.