Thursday November 14, 2019

FDA Approves Drug to Stop Some Malaria Relapses

Worldwide, malaria infects more than 200 million people a year and kills about half a million, most of them children in Africa

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FILE - The GlaxoSmithKline offices in London. On Friday, the U.S. Food and Drug Administration approved GlaxoSmithKline’s Krintafel, a simpler, one-dose treatment, to prevent relapses of a type of malaria. (VOA)

U.S. regulators Friday approved a simpler, one-dose treatment to prevent relapses of malaria.

Standard treatment now takes two weeks and studies show many patients don’t finish taking every dose.

Malaria is caused by parasites that are spread to people through mosquito bites. Anti-malarial drugs can cure the initial infection, but parasites can get into the liver, hide in a dormant form and cause recurrences months or years later. A second drug is used to stop relapses.

The new drug, GlaxoSmithKline’s Krintafel, only targets the kind of malaria that mainly occurs in South America and Southeast Asia. Most malaria cases and deaths are in Africa, and they involve another species.

In testing, one dose of Krintafel worked about the same as two weeks of the standard treatment, preventing relapses in about three-quarters of patients in six months, the company said.

Malaria is caused by parasites that are spread to people through mosquito bites.
Malaria is caused by parasites that are spread to people through mosquito bites. (VOA)

The Food and Drug Administration approved the drug for patients 16 and older, according to GlaxoSmithKline. The company said it’s the first new treatment in six decades for preventing relapses.

GlaxoSmithKline plans to apply soon for approval in Brazil, then other countries where the malaria type is common. It says it will sell the pills at low cost in poor countries.

Millions infected worldwide

Worldwide, malaria infects more than 200 million people a year and kills about half a million, most of them children in Africa. It causes fever, headache, chills and other flulike symptoms. The malaria type Krintafel targets causes about 8.5 million infections annually.

Also Read: Trial Wipes out More Than 80 per cent of Disease-Spreading Mosquitoes

The British drugmaker, working with the World Health Organization, is also developing what could be the world’s first malaria vaccine, but early testing indicates it’s not very effective. Prevention now focuses on using insecticides and bed nets. (VOA)

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FDA Wants Women Getting Breast Implants to Receive Stronger Warnings about Possible Risks and Complications

The recommendations are the agency's latest attempt to manage safety issues with the implants

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FDA, Women, Breast Implants
FILE - A photo shows the U.S. Food & Drug Administration (FDA) campus in Silver Spring, Maryland. VOA

U.S. health officials want women getting breast implants to receive stronger warnings about the possible risks and complications. FDA.

The Food and Drug Administration said Wednesday that manufacturers should add a boxed warning – the most serious type – to information used to market and prepare patients for implants.

The recommendations are the agency’s latest attempt to manage safety issues with the implants.

FDA, Women, Breast Implants
The Food and Drug Administration said Wednesday that manufacturers should add a boxed warning – the most serious type – to information used to market and prepare patients. Pixabay

In recent years, the FDA and regulators elsewhere have grappled with a link between a rare cancer and a type of textured implant, some of which have been recalled. Separately, the agency has received thousands of reports of health problems that some women attribute to the implants, including arthritis, fatigue and muscle pain.

Also Read- First Lady Speaks on Opioids in Only Solo Trip to Capitol Hill

The FDA will take public comment on the recommendations before adopting them. (VOA)