E-DRUG: Falsified batches of Coartem recently circulating in Cameroon (WHO)
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http://www.who.int/medicines/publications/drugalerts/Alert_130_Information_
Coartem_VF.pdf
WWW.WHO.INT
Ref. RHT/SAV/MD/IEA.130
8th November 2013
Information Exchange System
Drug Alert No. 130
Falsified batches of Coartem recently circulating in Cameroon
Background
This drug alert serves as an update to WHO Drug Alert No. 127 of 3 May
2013 concerning falsified batches of Coartem that were circulating in
Western and Central Africa.
http://www.who.int/medicines/publications/drugalerts/drugalertindex/en/.
Coartem is a fixed dose Artemesinin based combination therapy (ACT)
(Artemether 20mg and Lumefantrine 120mg), used for the treatment of
Plasmodium falciparum malaria. The genuine product is manufactured by
Novartis and is a WHO pre-qualified medicine.
On 5 November 2013, Novartis informed WHO of further falsified versions of
Coartem recently circulating in Cameroon.
Suspect medical products
Batch Number: NOF 2153
Manufacturing Date 01.2013
Expiry Date: 11. 2015
Batch Number F2929
Manufacturing Date: 01.2012
Expiry Date: 01.2016
The packaging of both batches is in English and bears the falsified green
leaf logo of the Global Fund Affordable Medicines Facility Malaria
(AMFm) programme.
The details of the falsified batches of Coartem circulated by WHO in May
2013 are as follows.
Batch number: F1901
Manufacturing Date: 01.2012
Expiry Date: 01.2014
The packaging is in English and bears a falsified stamp of the Nigerian
National Medicines Regulatory Agency, NAFDAC.
Batch Number: F2261
Manufacturing Date: 01.2012
Expiry Date: 01.2014 Page 2
The packaging is in English and bears the falsified green leaf logo of the
Affordable Medicines Facility Malaria (AMFm) programme. Novartis has
informed WHO that this batch has also been seen again recently in
Cameroon.
All four batches are packaged for adult use and for distribution within
the public sector. The falsified batches contain little or no active
pharmaceutical ingredient and are therefore ineffective.
Advice
Some of these batches of falsified Coartem have been found in a number of
West and Central African countries, both in hospitals and street markets.
Increased vigilance throughout the region is strongly advised for these
batches. Coartem should only be obtained from trusted, reliable and
established legal sources. Hospitals, clinics, and pharmacies should check
their stocks for these batches and report any suspicions to their national
medicines regulatory authority
If you have any questions or further information concerning these batches,
please contact rapidalert@who.int.
Falsified batches of Coartem recently circulating in Cameroon (WHO)