FDA Warns of Fake Potassium Iodide in Wake of Japan’s Nuclear Incident

Says no need for those is U.S. to buy KI for radiation, also says food supply safe, too

March 18, 2011 - There is no public health event requiring anyone in the U.S. to take potassium iodide (KI) because of the ongoing nuclear incident in Japan, says the Food and Drug Administration. The FDA acknowledges the public concern and says there has been an increase in demand for KI, the only FDA-approved drug used to prevent and treat the harmful effects of radiation.

The FDA posted on its site today a question-and-answer style statement about the potassium iodide products that also warns of fake drugs that may be on the market.

The statement says, “The FDA is alerting consumers to be wary of internet sites and other retail outlets promoting products making false claims to prevent or treat effects of radiation or products that are not FDA-approved. These fraudulent products come in all varieties and could include dietary supplements, food items, or products purporting to be drugs, devices or vaccines.”

The FDA also acknowledged that the demand for the drug has out run the demand and says it is working with companies that produce it to facilitate increased production.. FDA can’t provide an exact date on when that might happen but it will occur as quickly as possible.

On the same Web page with the alert about potassium iodide, the FDA has a smiliar Q&A about the food supply in the U.S. after the Japan nuclear reactor problems.

“Based on current information, there is no risk to the U.S. food supply,” the agency states clearly.

“FDA is closely monitoring the situation in Japan and is working with the Japanese government and other U.S. agencies to continue to ensure that imported food remains safe.

Below is the Q&A by the FDA on potassium iodide.

Hypothetically, if they were needed, what are the FDA-approved products for radiation exposure?

There are three FDA-approved potassium iodide (KI) products for use as an adjunct to other public health protective measures in the event that radioactive iodine is released into the environment. The three over-the-counter products are:

   ● Iosat Tablets (130 mg), Anbex, Inc., Williamsburg, Va., http://www.anbex.com

   ● ThyroSafe Tablets (65 mg), Recipharm AB, Jordbro, Sweden, http://www.thyrosafe.com

   ● ThyroShield Solution (65 mg/mL), Fleming & Company Pharmaceuticals, Fenton, Mo. http://www.thyroshield.com⁷

When administered in the recommended dose, KI is effective in reducing the risk of thyroid cancer in individuals or populations at risk for inhalation or ingestion of radioactive iodine. KI floods the thyroid with non-radioactive iodine and prevents the uptake of the radioactive molecules, which are subsequently excreted in the urine.

Potassium iodide works only to prevent the thyroid from uptaking radioactive iodine. It is not a general radioprotective agent.

There are three FDA-approved potassium iodide drugs marketed as over the counter products. They are: Iosat Tablets (130 mg), manufactured by Anbex, Inc.; ThyroSafe Tablets (65 mg), manufactured by Recipharm and ThyroShield Solution (65 mg/mL), manufactured by Fleming & Company Pharmaceuticals.

Is potassium iodide the only medication available for radiation exposure?

Potassium iodide is the only FDA-approved medication available for exposure to radioactive iodine. There are FDA-approved products available that increase the rate of elimination of other radioactive elements. They include:

   ● Calcium-DTPA and Zinc DTPA, Hameln Pharmaceuticals. Approved to treat known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.

   ● Radiogardase (Prussian blue insoluble capsules), HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG. Approved to treat known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium to increase their rates of elimination.

We have heard that potassium iodide is in short supply. Is that correct?

FDA daily evaluates the pharmaceutical supply for a wide variety of drugs to assess shortage issues.  

Despite the fact that there is no public health event in the U.S. requiring KI, FDA is aware of an increased demand for KI products. FDA is working with these companies to facilitate increased production.. FDA can’t provide an exact date on when that might happen but it will occur as quickly as possible.

Several components of the federal government maintain stockpiles of medical supplies for emergency situations. For instance, the CDC maintains the Strategic National Stockpile for civilian use, while the Department of Defense maintains their own supplies for support of military operations. The respective federal organizations should be contacted with any additional requests about the specific items and quantities in those stockpiles. Deployment of these stockpiles is governed by policies and procedures developed by the individual organizations based on available information and potential benefits and risks to public health.

Does FDA recommend that consumers purchase potassium iodide as a protective step?

No. There is no public health event requiring anyone in the U.S. to take KI because of the ongoing situation in Japan.

With exports from Japan disrupted, is there any possibility that some medical products could be in short supply?

FDA has been contacted by a few companies who receive product from Japan and the Agency is working with them on their supply issues.

Have U.S. manufacturers of potassium iodide been asked to ship any products to Japan?

At this time, the FDA is not aware of any request from Japan for potassium iodide. In addition, there is not a public health event requiring anyone in the U.S. to be taking KI because of the ongoing situation in Japan.

Drugs shipped to a foreign country, including as part of a humanitarian relief effort, are considered exports, and therefore, need to meet certain legal requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). If a drug is approved and is otherwise in compliance with the FFDCA’s requirements, there are no additional restrictions by FDA on its exportation. Drugs that are not approved or that otherwise are not in compliance with the FFDCA’s requirements may be exported if the exportation meets certain conditions and requirements.

If I see web sites advertising potassium iodide or alternative cures, should I buy the products?

Due to the public concern related the nuclear incident in Japan, there has been an increased demand for drugs, such as Potassium iodide (KI), used to prevent and treat the harmful effects of radiation.

According to the Nuclear Regulatory Commission, all the available information continues to indicate that the United States, including U.S. Territories, are not expected to experience any harmful levels of radiation from the event in Japan.

The FDA is alerting consumers to be wary of internet sites and other retail outlets promoting products making false claims to prevent or treat effects of radiation or products that are not FDA-approved. These fraudulent products come in all varieties and could include dietary supplements, food items, or products purporting to be drugs, devices or vaccines.

­Consumers should be wary of the following:

   ● claims that a product not approved by FDA can prevent or treat the harmful effects of radiation exposure;

   ● suggestions that a potassium iodide product will treat conditions other than those for which it is approved, i.e., KI floods the thyroid with non-radioactive iodine and prevents the uptake of the radioactive molecules, which are subsequently excreted in the urine;

   ● promotions using words such as “scientific breakthrough,” “new products,” “miraculous cure,” ”secret ingredient,” and ”ancient remedy”;

   ● testimonials by consumers or doctors claiming amazing results;

   ● limited availability and advance payment requirements;

   ● promises of no-risk, money-back guarantees;

   ● promises of an “easy” fix; and,

   ● claims that the product is “natural” or has fewer side effects than approved drugs.

Don't be fooled by professional-looking Web sites. Avoid Web sites that fail to list the company's name, physical address, phone number, or other contact information. For more tips for online buying, visit Buying Medicines and Medical Products Online. To determine if a particular drug is FDA approved, check The Orange Book or Drugs@FDA.

Consumers and health care professionals are encouraged to report adverse side effects or medication errors from the use of both approved and unapproved radiation exposure products to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch¹² or by calling 800-332-1088.

>> Click here to the FDA web page on the food and drug situation