A malaria pill, which has American soldiers scared due to its serious side effects, has been tamed and is now said to be safe for children in Kenya, Africa and Asia.

The new pill, soon to be registered in the country, is a combination of two chemical components called artesunate and mefloquine.

Artesunate, from a Chinese herb, is the primary ingredient in all recommended malaria medicines in Kenya but it is the second component, mefloquine, that causes serious side effects in some users.

Working alone under the brand name Lariam, Mefloquine has a long history of controversy for its recorded serious side effects including triggering suicidal thoughts and even causing insanity.

Mefloquine has been banned for use in the US and French armies following serious safety concerns while the British and Australian armies have since gone for alternatives. But developers now say its use in a new formulation and dosage has been proved safe and effective in a 63-day study involving children under five years in Western Kenya and other countries.

The study conducted in Bukina Faso, Tanzanian and Kenya involved 945 children under five who were given a pill a day for three days. Researchers say it was found to be safe and effective.

"The long-term malaria prevention with mefloquine alone should not be confused with the three-day only treatment we have developed for children, which is very safe," said Drugs for Neglected Diseases Initiative (DNDi) Executive Director Bernard Pécoul.

NEGLECTED DISEASES

DNDi is an international organisation making new treatments for neglected diseases and are the developers of the malaria drug in question.

Replying to our email, Dr Pecoul said the safety levels of their new drug meet World Health Organisation standards and it is as good as Kenya's first-line malaria treatment.

However, he agreed that mefloquine causes mental problems in a small number of travellers who use it for prevention. The director advised against the use of the mefloquine containing drug more than once in two months to avoid the risk of children developing psychiatric problems. This brings into question the suitability of such a medicine as a first-line treatment in regions where malaria attacks are so regular.

A recent study in Siaya, Tanzania and Mozambique to test the suitability of mefloquine-containing malaria drugs for preventing the disease in pregnant women has also questioned the safety of the compound. Co-authored by 21 Kenyan, Tanzanian, US and Spanish researchers and published in September in the journal Plos Medicine, the team linked mefloquine to higher rates of side effects.

Apart from higher cases of dizziness, vomiting, nausea and headache in groups given drugs containing mefloquine, the researchers linked the compound to a high risk of mother-to-child transmission of HIV.

But in his defence of mefloquine, Pecoul said the US Food and Drug Agency (FDA) still approves it for the prevention and treatment of malaria because it is effective and tolerated by most people.

A press statement by DNDi released from the US last month says the new combination drug will be manufactured by Cipla of India.