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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P06-04
January 11, 2006

Media Inquiries:
Catherine McDermott, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

FDA Cautions Consumers Against Filling U.S. Prescriptions Abroad
Drugs With Same or Similar Names May Contain Different Active Ingredients Than in U.S. and Pose Health Risks

The U.S. Food and Drug Administration (FDA) is warning healthcare professionals and consumers that filling their prescriptions abroad may have adverse health consequences because of confusion with drug brand names that could inadvertently lead consumers to take the wrong medication for their condition. An FDA investigation has found that many foreign medications, although marketed under the same or similar-sounding brand names as those in the United States, contain different active ingredients than in the United States. Taking a different active ingredient may not help, and may even harm, the user.

"Consumers who fill U.S. prescriptions abroad, either when traveling or when shopping at foreign internet pharmacies, need to be aware of this potential health hazard," said Dr. Murray Lumpkin, Deputy Commissioner for International and Special Programs. "The name of a drug bought from another country may be identical or similar to the name on the U.S. prescription, but the active ingredient in the medicine may be different and not provide the right treatment."

FDA's investigation illustrates this health risk inherent in filling U.S. prescriptions abroad and highlights the lack of standardization of drug trade names internationally. For example, in the United States, "Flomax" is a brand name for tamsulosin, a treatment for an enlarged prostate, while in Italy, the active ingredient in the product called "Flomax" is morniflumate, an anti-inflammatory drug. In the United States, "Norpramin" is the brand name for an anti-depression drug containing desipramine but, in Spain, the same brand name, "Norpramin," is used for a drug that contains omeprazole, a treatment for stomach ulcers. While some of the identical brand names have different active ingredients appropriate for the same health condition, even these products should not be substituted without the guidance of a healthcare professional because of the potential for different doses, side effects, allergies, and interactions with other drugs.

FDA also has found 105 U.S. brand names that have foreign counterparts that look or sound so similar that consumers who fill such prescriptions abroad may receive a drug with the wrong active ingredient. For example, in the United Kingdom, "Amyben," a brand name for a drug product containing amiodarone, used to treat abnormal heart rhythms, could be mistaken for "Ambien," a U.S. brand name for a sleeping pill. Using Amyben instead of Ambien could have a serious adverse outcome.

For more information, see FDA's Public Health Advisory at www.fda.gov/oc/opacom/reports/confusingnames.html.

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