Drug
Aliases:
Topic aliases are alternate phrasings for a particular topic.
acetylsalicylic acid
salicyclic acid
acetylsalicylate
On reviewing the link between adminsitration of aspirin and the occurence of Reye Syndrome in 2004, TGA recommendations were :
"The available evidence suggests that while a proportion of cases meeting the definition of Reyes Syndrome are in fact other conditions (including inborn errors of metabolism, drug toxicity or others), there have still been a number of cases of “idiopathic” or “classic North American-type” Reyes Syndrome. Although individually many of the studies investigating a possible link between aspirin and Reyes Syndrome are flawed, the overall weight of evidence suggests that there is a real association between aspirin administration during the prodromal illness, and this “idiopathic” Reyes Syndrome. Whether this link is causal has not been proven.
Given the above information, the current Australian aspirin warning statement “Consult a doctor before giving this medicine to children or teenagers with chicken pox, influenza or fever” still seems relevant. However, given the small number of cases of Reye’s Syndrome in Australia in the last ten years, and in particular the small number of cases in the 10-19 year age group, there is no evidence to suggest that a stronger warning, such as the new UK warning “Do not give to children under the age of 16 years, unless on the advice of a doctor” is necessary on safety grounds.
In the interests of simplifying warnings on the labels of aspirin-containing products, the MEC, at it’s meeting on 3 April 2003, recommended the following statements for consideration by NDPSC for inclusion in Appendix F of the SUSDP in relation to aspirin:
“Don’t use [this product/ name of the product]
• If you have a stomach ulcer;
• In the last 3 months of pregnancy
• If you are allergic to aspirin or anti-inflammatory medicines.
Unless a doctor has told you to, don’t use [this product/ name of the product]
• For more than a few days at a time
• If you have asthma;
• In children under 12 years of age;
• If you are pregnant.”
The existing warning statement regarding Reyes syndrome could be incorporated into this new warning format by adding “In children 12-16 years of age with or recovering from chicken pox, influenza or fever” under the dot point relating to children under 12 years of age."
www.tga.gov.au/pdf/archiv...
"The available evidence suggests that while a proportion of cases meeting the definition of Reyes Syndrome are in fact other conditions (including inborn errors of metabolism, drug toxicity or others), there have still been a number of cases of “idiopathic” or “classic North American-type” Reyes Syndrome. Although individually many of the studies investigating a possible link between aspirin and Reyes Syndrome are flawed, the overall weight of evidence suggests that there is a real association between aspirin administration during the prodromal illness, and this “idiopathic” Reyes Syndrome. Whether this link is causal has not been proven.
Given the above information, the current Australian aspirin warning statement “Consult a doctor before giving this medicine to children or teenagers with chicken pox, influenza or fever” still seems relevant. However, given the small number of cases of Reye’s Syndrome in Australia in the last ten years, and in particular the small number of cases in the 10-19 year age group, there is no evidence to suggest that a stronger warning, such as the new UK warning “Do not give to children under the age of 16 years, unless on the advice of a doctor” is necessary on safety grounds.
In the interests of simplifying warnings on the labels of aspirin-containing products, the MEC, at it’s meeting on 3 April 2003, recommended the following statements for consideration by NDPSC for inclusion in Appendix F of the SUSDP in relation to aspirin:
“Don’t use [this product/ name of the product]
• If you have a stomach ulcer;
• In the last 3 months of pregnancy
• If you are allergic to aspirin or anti-inflammatory medicines.
Unless a doctor has told you to, don’t use [this product/ name of the product]
• For more than a few days at a time
• If you have asthma;
• In children under 12 years of age;
• If you are pregnant.”
The existing warning statement regarding Reyes syndrome could be incorporated into this new warning format by adding “In children 12-16 years of age with or recovering from chicken pox, influenza or fever” under the dot point relating to children under 12 years of age."
www.tga.gov.au/pdf/archiv...
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Feb 24, 2013