First oral drug for Kala azar
India licenses the first oral drug called Miltefosine for visceral leishmaniasis (kala azar). It is the first oral drug, which has proved to be highly effective and safe and is likely to cost less. This drug could save the lives of thousands of people who die from the disease every year.
The World Health Organization (WHO) recently announced the development of the first oral treatment for visceral leishmaniasis, also known as black fever or kala azar.
Leishmaniasis is a parasitic disease caused by Leishmania donovani
and spread by a species of sandfly, the female phlebotomine sandfly. It is one of the neglected diseases, which have become a special focus at WHO, and afflict the world's poorest people. The disease has two main forms - the cutaneous form which affects the skin and the visceral form that affects the internal organs. Visceral leishmaniasis causes swelling and enlargement of the spleen and liver in addition to anaemia and is 100% fatal in untreated cases. Ninety percent of all cases occur in five countries - India, Bangladesh, Brazil, Nepal and Sudan. The disease usually takes on epidemic proportions when it occurs. Visceral leishmaniasis is the commonest form in India and the last major epidemic was reported from Bihar in 1977, with more than 100,000 cases. Assam, Bihar, eastern Uttar Pradesh, foothills of Sikkim report the maximum number of cases and are endemic for kala azar.
The new oral medicine, Miltefosine, has been shown in clinical trials to be 95% effective against the disease and was licensed for use in India this week. The drug has been produced in collaboration with WHO, the German pharmaceutical company, Zentaris, the World Bank, and the U.N. Development Programme. This drug has moved from the laboratory bench to registration in six years; most medicines take twice as long. Miltefosine will help in treating the 500,000 people who develop visceral leishmaniasis each year, and could save most of the 60,000 people who die from the disease every year. It is likely to cost less and is much easier to take than all current therapies.
Until now, all treatments for the disease have had substantial drawbacks. Some are toxic and can cause permanent, irreversible damage such as diabetes. Up to 60% of cases in India are now resistant to the first line drug. Other drugs trigger dangerous reactions that can be lethal in about 9% of treated patients. Miltefosine proved to be highly effective and safe and was approved by the Indian authorities. India has half the world's cases of visceral leishmaniasis and it is hoped that Miltefosine will help the country reach its target of eliminating the disease by 2010.
WHO Press Release /46 June 2002
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