Background
In early 2013 a batch of falsified Coartem was discovered in Yaoundé, Cameroon, containing no active pharmaceutical ingredients.
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.
A pharmacist in Yaoundé requested Minilab testing as he suspected that the product was ineffective. The product failed screening by the minilab and was forwarded by an NGO to a WHO pre-qualified laboratory in Nairobi, Kenya, for more detailed analysis. Subsequent testing revealed that the product contained neither of the correct active pharmaceutical ingredients.
On 9 April 2013 WHO were informed by the NGO of the discovery of this falsified batch. Contact was subsequently established with all National Medicine Regulatory Authorities and Novartis.
It has now been established that a second batch of falsified Coartem has been circulating in West and Central Africa recently.
Product details and information is available here.
Increased vigilance throughout the supply chain is strongly advised for these batches. Coartem should only be obtained from trusted, reliable, and established legal sources.
If you have any questions or further information concerning this batch, or any is found or reported in your country, please, contact rapidalert@who.int.