Other safety alerts
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| European Union: EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable |
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The European Medicines Agency (EMA) announces that product information for Noxafil (posaconazole) is to be updated to strengthen warnings that the two dose forms given by mouth cannot be simply interchanged at the same dose. Noxafil, a medicine for serious fungal infections, is available by mouth as tablets (100 mg) and oral suspension (40 mg/ml), but the recommended doses for the two forms are different.
Some patients have mistakenly received oral solution instead of tablets, leading to underdosing and to a potential lack of effect. Similarly, there are reports of patients given tablets instead of oral solution, leading to overdosage and side effects.
The product information is therefore to be updated to strengthen existing warnings that the two forms cannot be simply interchanged, and the packaging will also be changed to distinguish the two forms more clearly and to carry a warning statement that they should not be substituted for one another without adjusting the dose. It is important that the dosage form as well as the relevant dose be specified on the prescription, and that pharmacists ensure the correct oral dosage form is dispensed.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002557.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, Noxafil Oral Susp 40mg/ml (HK-56439) is a pharmaceutical product registered by Merck Sharp & Dohme (Asia) Ltd, and is a prescription only medicine; while Noxafil tablet is not registered. Related news was previously issued by the United States Food and Drug Administration (FDA) and was posted on Drug Office website on 5 January 2016. So far, the Department of Health (DH) has not received any adverse drug reaction case related to the product. As there is only one Noxafil oral formulation registered in Hong Kong, the EMA announcement of dosing errors when switching between different oral formulations does not have any impact on Hong Kong.
Ends/ Saturday, June 25, 2016
Issued at HKT 12:00
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