The action follows discontinuation of quinidine, the only FDA-approved intravenous antimalarial drug in the United States.
This article was updated March 29, 2019.
The CDC is issuing new guidance to clinicians for the treatment of severe cases of malaria.
The action follows discontinuation of quinidine, the only FDA-approved intravenous (IV) antimalarial drug in the United States.1
Malaria has long been a major cause of death and illness worldwide, with an estimated 219 million cases of the disease and 435,000 deaths in 2017. In the United States, an average of 1700 travelers to malaria-endemic countries return with the disease, according to the CDC.
Among these travelers, about 300 return with severe malaria.1
In an interview, Dr Katherine Tan, Domestic Malaria Chief in the CDC's Division of Malaria and Parasitic Diseases, said although malaria was considered "eliminiated" in the United States in the 1950s, the disease continues to be imported by people traveling to areas where mosquitoes carry the disease.
"Malaria has increased over the past few decades in the United States. I think this will continue to be an increasing issue," said Tan.
Quinidine was discontinued by its manufacturer and will no longer be available, according to the CDC.2
Instead, the United States will follow suit with the World Health Organization's recommendation for artesunate as a first-line treatment for severe malaria, starting April 1.1
Artesunate is neither commercially available nor FDA approved in the United States. However the CDC has made the drug available, supplied by the US Army Medical Research and Material Command, since 2007, in cases where quinidine was not available.2 The CDC has ensured the IV drug is available through an expanded use investigational new drug protocol, an FDA regulatory mechanism.1,2
According to Tan, the efficacy of artesunate has been proven, and the international community has used it for years. FDA approval relies on drug companies submitting applications to the agency for artesunate.
"Artestenate is the world standard," Tan said. "The ideal situation would be to have our artesunate FDA approved. Until then, we have this mechanism to have it released [on a limited basis]."
Clinical studies have shown that IV artesunate is safe, well tolerated and can be administered to infants, children, and pregnant women in their second and third trimesters, as well as during lactation, according to the CDC.
In the first trimester of pregnancy, the benefits of IV artesunate treatment outweigh the risk of death and poor outcomes due to severe malaria.1
In order to obtain IV artesunate, clinicians in the United State are required to call the CDC’s Malaria Hotline (770-488-7788). When consultation with a CDC expert determines that the drug is needed, IV artesunate will be released free of charge to one of the 10 CDC quarantine stations stocked with it.1
The CDC will match hospitals, are responsible for the pickup arrangements, with the nearest quarantine station. It will work with the hospitals and stations to ensure swift receipt of the treatment, according to the agency.
Tan said the quarantine station locations were chosen by where they were most needed, based on reported cases of malaria, and the CDC is continuing to monitor time of delivery. "Getting the artesunate to patients is high priority to us," said Tan.
The CDC says it anticipates there being sufficient supply of IV artesunate for treatment of all cases of severe malaria in the United States.1
Meanwhile, preventing transmission of the disease can help reduce the number of individuals needing artesunate for malaria treatment.
"When people go abroad for their tropical vacations, they need to be prepared," said Tan.
She recommends utilizing mosquito nets for sleeping, staying in accommodations with air conditioning, using effective mosquito repellent, and wearing protective clothing, such as long sleeves and pants.
The CDC Malaria Hotline (770-488-7788) is available Monday through Friday, 9 a.m. to 5 p.m., Eastern time. Outside these hours, providers should call 770-488-7100 and ask to speak with a CDC malaria expert.1