MARCH 01, 2006

The growing appetite of US consumers for lower-cost foreign drugs may be contributing to the danger of health-threatening medication mix-ups, FDA officials warned.

The agency has long cautioned Americans against importing prescription medications from Canada and other countries, arguing that such imports may be adulterated or even counterfeit. Now officials are adding a new worry: the possibility that confusion over drug brand names in other countries could inadvertently lead consumers to take the wrong medication.

FDA investigators have found that many foreign medications marketed under the same or similar-sounding brand names as those in the United States actually contain different active ingredients than in the United States.

As an example, FDA cited the US drug Flomax—a brand name for tamsulosin, a treatment for an enlarged prostate. In Italy, however, the active ingredient in the product called Flomax is morniflumate, an anti-inflammatory drug. Similarly, in the United States, Norpramin is the brand name for an antidepression drug containing desipramine. In Spain, the same brand name, Norpramin, is used for a drug that contains omeprazole, a treatment for stomach ulcers.

Additionally, the FDA officials cited >100 US drug 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.

"Consumers who fill US 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, FDA deputy commissioner for international and special programs.