FDA: Drug Name Confusion Makes Imports Dangerous

Agency warns of prescription mix-ups, but critics suspect an anti-import agenda

MONDAY, Jan. 16, 2006 (HealthDay News) -- Many consumers, doctors and pharmacists are unaware that drugs sold in the United States can have the same brand name or the same sounding name as drugs sold abroad -- but with totally different ingredients, according to an alert from the U.S. Food and Drug Administration.

Medication name mix-ups raise risks for serious health consequences to consumers should they end up buying and using the wrong medicine, the agency said.

An FDA study of drugs marketed in 28 countries worldwide found scores of cases where similar prescription names could lead to serious health woes.

However, one leading consumer advocate group believes the FDA is highlighting the danger to help further the Bush Administration's anti-drug importation agenda.

Sharon Treat is executive director of the National Legislative Association on Prescription Drug Prices (NLAPDP), which advocates for the importation of cheaper drugs for America's cash-strapped consumers. She believes the FDA is trying once again to scare patients away from the practice.

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

But Ilisa Bernstein, director of pharmacy affairs at the FDA, said it is important for consumers to know that safeguards against medication name confusion aren't always in place in other countries.

"At FDA, we have been interested in making sure that the names of drugs aren't confusing to health professionals," Bernstein said. "We have systems in place in the United States to minimize the risk of having confusing drug names."

She noted 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 result: "We found that 105 U.S. brand names are so similar to foreign brand names that patients could get a drug with the wrong ingredients," Bernstein said. "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.

A case reported in January 2005 by the Institute for Safe Medication Practices highlights the problem, the FDA said. The case involved a patient traveling in Serbia who 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 United States, the institute reported.

Another example from the FDA is the drug Ambyen, which is a brand name in the United Kingdom for amiodarone, used to treat abnormal heart rhythms. Being prescribed Ambyen instead of Ambien, a popular sleep medication sold in the United States, could lead to serious adverse outcomes, the FDA pointed out.

"If you're traveling abroad, bring enough medication and then a little bit more, in case your travel plans are changed," Bernstein advised. "If you lose your medication while you are traveling, or run out, get advice from a qualified medical expert, because going to the pharmacy, you could get the wrong drug," she added.

Bernstein also advised not to buy drugs over the Internet, unless you are buying from a licensed pharmacy in the United States. "Otherwise it's a 'buyer beware' market -- you don't know what you are going to get," she said.

But Treat, of the National Legislative Association on Prescription Drug Prices, said this latest FDA safety alert echoes previous moves made in the recent past. She noted that right before Christmas, the U.S. Border Patrol seized packages of medications coming from Canada and sent letters to recipients warning them that these drugs might be dangerous. "The letters said these drugs aren't safe, we can't guarantee it and that you give up all rights to have this drug," she said.

The object of this policy was to get seniors to opt for the new Medicare prescription drug plan, even though it might end up costing patients more than they pay for Canadian drugs, Treat said. "For people who are getting their drugs from Canada and elsewhere, the Medicare plan is not necessarily a good deal," she said.

In December, the FDA publicized findings from "Operation Bait and Switch," a sting operation in which the agency intercepted drug shipments ordered by Americans from companies claiming to get their drugs from Canada. In fact, the FDA said, 85 percent of the drugs seized were manufactured in more than 27 other countries worldwide.

The supply of Canadian drugs to American consumers may be drying up, anyway. Citing concerns that it could not keep up with American demand, the Canadian government announced last summer it would ban bulk sales of prescription medications from Canadian pharmacies to their U.S. counterparts. The move has forced many bargain-hunting American consumers to turn to supplies from Europe and elsewhere.

One expert stressed, however, that confusion over drug names remains an important and often overlooked problem.

"We are happy to see the FDA advisory," said Michael R. Cohen, president of the non-profit Institute for Safe Medication Practices. "We frequently see this problem," he added.

Cohen considers importing drugs from abroad potentially risky. "I am not one of those people who is against it," he said. "I am very objective about it. We could care less about whether the pharmaceutical industry is losing money. But, as far as safety, when we see things like this, we just don't think enough attention has been paid by legislators to address all these safety issues."

"People have to know the names of their drugs," Cohen said. "But not just the brand name -- they have to know the generic name," he said.

Cohen sees both positive and negative points in patients importing drugs. "The positive is you are going to save money. The negatives are inconvenience, counterfeiting and what you see in the FDA public health advisory."

More information

The FDA can tell you more about international medication names.

SOURCES: Ilisa Bernstein, Pharm.D., J.D., director, pharmacy affairs, U.S. Food and Drug Administration, Rockville, Md.; Sharon Treat, executive director, National Legislative Association on Prescription Drug Prices, Hallowell, Maine; Michael R. Cohen, R.Ph., MS, Sc.D., president, Institute for Safe Medication Practices, Huntingdon Valley, Pa.; Jan. 12, 2006, FDA press release
Consumer News