FDA Issues Instructions for Nuclear Accident Thyroid Antidote
(AP) WASHINGTON
The government issued instructions Monday for use of a drug that can protect against thyroid cancer in case of a nuclear accident or terrorism.
The Food and Drug Administration began updating the nuclear antidote instructions more than a year ago, but finalized them amid heightened tension following the Sept. 11 terrorist attacks.
The new instructions deal with emergencies involving the release of radioactive iodine. This compound, either inhaled or ingested through contaminated food or milk, can cause people to develop thyroid cancer. Children are most at risk, and can be harmed by radiation levels far lower than those that endanger adults.
Indeed, four years after the 1986 Chernobyl nuclear accident, children who had lived downwind of the site experienced a 30- to 60-fold increase in thyroid cancer, according to studies FDA cited.
Potassium iodide, or KI, has long been known to reduce that risk and has been used as an antidote after nuclear accidents. But results from Chernobyl showed the FDA that its last dosing instructions for KI, issued in 1982, needed to be updated.
The big change: Instead of one dose for babies and another for all other ages, the FDA now recommends far different doses for children of different ages.
Also, the antidote should be administered to children and pregnant or nursing women when they are exposed to doses of radioactive iodine that are one-fifth the level previously thought harmful, the FDA concluded. In contrast, adults over age 40 wouldn't need the antidote unless they were exposed to a massive dose, and young adults would be treated if contamination was in a mid-range.
Besides other protective measures, such as evacuating people out of danger zones and providing safe food, newborns would need a daily dose of 16 milligrams of KI until exposure was deemed over, the FDA instructions say. Children ages one month to 3 years would get 32 mg; children ages 3 to 18 65 mg; and 130 mg for adults.
On the Net:
Food and Drug Administration guidelines: http://www.fda.gov/cder/guidance/4825fnl.htm
|
