Malaria Drug Off Market Over Side-effect Fears
Drug once lauded as offering new hope for Africa withdrawn by the British manufacturer
An anti-malarial drug which was once lauded as offering new hope for Africa has been withdrawn by the British manufacturer because of its side-effects.
GlaxoSmithKline's announcement that it was taking Lapdap off the market and recalling it from pharmacies in Kenya came more than three years after the World Health Organization warned it could cause severe anaemia in children, which would require a blood transfusion. In most of Africa, that would not be possible.
WHO's experts said in their 2004 report that, even though there is a desperate need for new anti-malarials, there were safety issues with the drug. They pointed out that the regulators in the UK, which licensed the drug although it is not used in Britain, had said it should not be given to patients who had a hereditary enzyme disorder called glucose-6-phosphate dhydrogenase deficiency (G6PD). The studies had shown such patients were more likely to suffer anaemia.
Screening for the enzyme disorder is possible, but not available in most of Africa for the children, aged three months to 12 years, for whom the drug was intended. At least 10% and possibly as many as a quarter of Africans have the disorder.
Following the report, which recommended restrictions on the use of Lapdap, GSK agreed "not to commercialise" the drug, the company said. No more shipments were sent to Africa. However, Kenya had a special agreement to order the drug directly from the manufacturers, which GSK said yesterday it had not been aware of.
The latest data, confirming the problem, came from two new trials of Dacart, which is a combination of Lapdap and artesunate - a drug derived from a Chinese herb which the WHO has ruled should be the mainstay of malaria treatment in Africa. GSK yesterday also terminated further work on Dacart.
The end of Lapdap is a blow to the fight against malaria and also for the public/private partnerships for diseases in the developing world. GSK developed the drug with the not-for-profit Medicines for Malaria Venture, WHO and the UK's Department for International Development.
GlaxoSmithKline's announcement that it was taking Lapdap off the market and recalling it from pharmacies in Kenya came more than three years after the World Health Organization warned it could cause severe anaemia in children, which would require a blood transfusion. In most of Africa, that would not be possible.
WHO's experts said in their 2004 report that, even though there is a desperate need for new anti-malarials, there were safety issues with the drug. They pointed out that the regulators in the UK, which licensed the drug although it is not used in Britain, had said it should not be given to patients who had a hereditary enzyme disorder called glucose-6-phosphate dhydrogenase deficiency (G6PD). The studies had shown such patients were more likely to suffer anaemia.
Screening for the enzyme disorder is possible, but not available in most of Africa for the children, aged three months to 12 years, for whom the drug was intended. At least 10% and possibly as many as a quarter of Africans have the disorder.
Following the report, which recommended restrictions on the use of Lapdap, GSK agreed "not to commercialise" the drug, the company said. No more shipments were sent to Africa. However, Kenya had a special agreement to order the drug directly from the manufacturers, which GSK said yesterday it had not been aware of.
The latest data, confirming the problem, came from two new trials of Dacart, which is a combination of Lapdap and artesunate - a drug derived from a Chinese herb which the WHO has ruled should be the mainstay of malaria treatment in Africa. GSK yesterday also terminated further work on Dacart.
The end of Lapdap is a blow to the fight against malaria and also for the public/private partnerships for diseases in the developing world. GSK developed the drug with the not-for-profit Medicines for Malaria Venture, WHO and the UK's Department for International Development.
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