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10/2/2003

'Dirty Bomb' Radioprotective Agent Approved by FDA

Cheryl A. Thompson

The Food and Drug Administration (FDA) today approved the marketing of the first commercial product that can be used to treat patients who may have ingested or inhaled thallium or radioactive cesium after the release of a radiological dispersal device, or "dirty bomb."

Prussian blue, an insoluble dark blue pigment that passes through an undamaged gastrointestinal tract, binds thallium and cesium isotopes and carries them out of the body, according to draft product labeling from FDA. The purpose of ingesting Prussian blue is to remove as much of the isotopes as possible before they can be absorbed into the body and do damage.

FDA had published the draft labeling in February with an invitation for manufacturers to submit a new drug application for 500-mg Prussian blue capsules.

According to that invitation, the federally supported Radiation Emergency Assistance Center/Training Site has distributed Prussian blue capsules under an investigational new drug application (IND) owned by Oak Ridge Institute for Science and Education. Germany's Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. KG makes the capsules used under the IND and is the company whose paperwork was approved today by FDA.

The agency's draft labeling states that constipation, the most frequently reported adverse event from Prussian blue ingestion, developed in about one fourth of the persons who took the compound after internal exposure to radioactive cesium. There are no contraindications to the use of Prussian blue capsules.

The draft labeling also states that the recommended dosage of Prussian blue in adults and adolescents is 3 g three times a day. Children ages 2–12 years should take 1 g three times a day. Treatment after exposure to radioactive cesium should continue for at least 30 days. To ease the gastrointestinal effects of Prussian blue therapy, the dosage in adults and adolescents may be decreased to 1 or 2 g three times a day once the level of internal radioactivity has greatly diminished.

FDA said Heyl would have its Prussian blue capsules available within eight weeks. The brand name of the product is Radiogardase.