Other safety alerts
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| European Union: EMA completes review of polymyxin-based medicines |
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The European Medicines Agency (EMA) has reviewed the safety and effectiveness of products containing the antibiotics colistin or colistimethate sodium (known as polymyxins) and recommended changes to their product information to ensure safe use in the treatment of serious infections that are resistant to standard antibiotics.
Polymyxin-based products have been available since the 1960s, but their use quickly decreased due to the availability of antibiotics with fewer potential side effects. Due in part to this limited use, colistimethate sodium has retained activity against a number of bacteria which have become resistant to commonly used antibiotics.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed the available data about the pharmacokinetics, effectiveness and safety of these medicines. The CHMP concluded that injection or infusion (drip) of colistimethate sodium should be reserved for the treatment of serious infections due to susceptible bacteria, in patients whose other treatment options are limited. The medicine should be given with another suitable antibiotic where possible. The Committee recommended that doses should always be expressed in international units (IU) but because doses of colistimethate sodium can be expressed in different ways a conversion table should be included in the product information. Critically ill patients should be given a higher starting dose (loading dose) to provide an effective level of the antibiotic in the body more quickly. Although data were very limited, the Committee recommended doses for use in patients with kidney problems and in children, and provided guidance on dosage in adults when given directly into fluid surrounding the brain or spinal cord (intrathecal or intraventricular injection).
CHMP concluded that colistimethate sodium may also be given by inhalation or in a nebuliser to treat ongoing (chronic) infections with the bacterium Pseudomonas aeruginosa in patients with cystic fibrosis.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final decision in due course.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002194.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there is one registered pharmaceutical product registered for human use, namely Colomycin for Inj 1 Million IU (HK-58514), containing Colistimethate. The product is prescription medicine. The Drug Office of Department of Health (DH) will remain vigilant on the final decision made by the European Commission and follow up any update on the relevant safety i
Ends/Saturday, 25 October, 2014
Issued at HKT 12:00
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