Drug Name Confusion Makes Imports Dangerous: FDA

by Medindia Content Team on  January 17, 2006 at 2:14 PM Drug News   - G J E 4
Drug Name Confusion Makes Imports Dangerous: FDA
Many doctors and pharmacists in the U.S. are not aware that ingredients of drugs sold abroad are different from ingredients of drugs of the same brand name or a similar sounding name in the country.

An alert from the U.S. Food and Drug Administration (FDA) said medication name mix-ups pose serious health consequences to consumers if they end up buying and using the wrong medicine.

An FDA study of drugs marketed in 28 countries across the globe found many cases where similar prescription names could lead to disasters.

National Legislative Association on Prescription Drug Prices (NLAPDP), a leading consumer advocate group which advocates import of drugs to supply cheaper medicine to the cash-strapped American consumer, believes the FDA is highlighting the danger to help further the Bush Administration's anti-drug importation agenda.

Sharon Treat, executive director of the NLAPDP said, "All this alert does is prove the point that you need a regulated program for imported drugs.This is part of a U.S. government campaign to discourage enactment of legislation to import drugs from other countries," she added.

However, Ilisa Bernstein, director of pharmacy affairs at the FDA, said systems were in place in the U.S. to minimize the risk of having confusing drug names. The American consumer needs to know that safeguards against confusion of names of medicines did not exist in many other countries. There are no such systems to deal with this problem internationally.

Bernstein said the FDA review did not cover "every single drug in the world." However, "we did an analysis of drugs marketed in 28 countries and the U.S.," she said.

The FDA review, which covered drugs marketed in 28 countries in the world, found that 105 U.S. brand names are so similar to foreign brand names that patients could get a drug with the wrong ingredients. In addition, 18 of the foreign brand names have the same name as a U.S. marketed drug, but different ingredients.

The concern about confusing brand names is two-fold, she explained. First, patients traveling abroad could get the wrong medication while trying to fill a prescription. Second, patients ordering medications from abroad may be sent the wrong drug. Both of these scenarios can have serious consequences, Bernstein said.

FDA quoted a case reported in January 2005 by the Institute for Safe Medication Practices to highlight the problem. A patient traveling in Serbia ran out of his prescription for Dilacor XR (diltiazem extended release), which is used to treat high blood pressure. A Serbian pharmacist filled the prescription with digoxin, because in Serbia, Dilacor is a brand name for digoxin. Digoxin is used to treat heart failure as well as abnormal heart rhythms. The patient continued taking the medication without realizing it was digoxin and not diltiazem, and was hospitalized with life-threatening drug toxicity after his return to the U.S. the institute reported.

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