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Foreign Drugs May Have Same Name as US Product but
Different Ingredients
FDA warns confusion with brand names can be disaster
Jan. 12, 2006 - An FDA investigation by the U.S.
Food and Drug Administration 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, warns the FDA.
The 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.
"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.