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U.S. Department of Health and Human Services

Drugs

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FDA Public Health Advisory, January 2006: Consumers Filling U.S. Prescriptions Abroad May Get the Wrong Active Ingredient Because of Confusing Drug Names

The U.S Food and Drug Administration (FDA) is advising healthcare professionals and consumers that filling U.S. prescriptions abroad may give patients the wrong active ingredient for treating their health condition. Some FDA-approved products have the same brand names as drug products that are marketed outside the U.S. but contain completely different active ingredients. In addition, 105 U.S. brand names are so similar to foreign brand names used for products with different active ingredients that patients who fill prescriptions abroad may inadvertently get the wrong drugs. Using the wrong drugs creates avoidable risks of adverse drug reactions with no health improvements. Consumers who fill U.S. prescriptions abroad, either when traveling or when shopping at foreign internet pharmacies, need to take caution because foreign drugs may use identical or potentially confusing brand names for products with different active ingredients.

Identical or very similar brand names, if associated with different active ingredients, may cause preventable pharmacy errors because approximately three quarters of all U.S. prescriptions are written using brand names rather than the scientific (or so-called "generic") names of the active ingredients.1 To minimize confusion within the U.S., FDA has procedures in place to review brand names for use in the U.S. proposed by the manufacturer, relative to U.S. marketed product names. No international regulatory system exists, however, to ensure that new brand names are sufficiently different from existing ones elsewhere in the world to prevent undue confusion by pharmacists who are filling prescriptions from outside their country.

The FDA found 18 foreign drug products that use the same brand name as an FDA-approved medication but contain a different active ingredient. Table 1 lists the 18 foreign brand names, along with the active ingredients used in the U.S. and abroad, and the foreign country where the other active ingredient is marketed. The list excludes drug products available only in a hospital setting and drugs regulated as controlled substances in the U.S. This list focuses on prescription-only products, although similar and identical names exist among over-the-counter remedies.2 While some of the identical brand names have different active ingredients appropriate for the same health condition, these products should not be substituted without the guidance of a healthcare professional due to different doses, side effects, allergies, and interactions with other drugs.

FDA cautions that this list of identical brand names used for different drugs in other countries is probably not comprehensive and is subject to change. To develop this list, FDA used Chemindex(TM), a proprietary database from a data vendor named IMS Health to compare brand names for single-ingredient products marketed in the U.S. and 28 other industrialized countries in 2003.3 FDA also used Martindale Product Index, an online drug reference database to identify some foreign drug names and indications.

Earlier reports confirm the risks described here. In a January 13, 2005 newsletter, the Institute for Safe Medication Practices (ISMP) described a serious adverse event resulting from drug marketed abroad that had the same name as a product marketed in the U.S. but contained an active ingredient different from the product in the U.S. ISMP described a patient who traveled to Serbia and ran out of Dilacor XR (diltiazem extended release), marketed by Watson Labs in the U.S., and used to treat high blood pressure. A Serbian pharmacist filled the prescription with digoxin 0.25 mg because in Serbia, Dilacor, marketed by a local company, is a brand name for digoxin. Digoxin is used to treat heart failure as well as abnormal heart rhythms, and requires blood testing for close monitoring of the amount of the drug in the body to avoid serious adverse events. The patient, who continued taking the medication without realizing it was digoxin and not diltiazem, was hospitalized with life-threatening drug toxicity after his return to the U.S. An article in the Wall Street Journal on August 16, 2005 noted the risks inherent in identical brand names being used for products with different active ingredients and listed six such brand names for drugs sold in the both U.S. and in Europe. 4

FDA has also found 105 U.S. brand names for which there are foreign brand names that look or sound so much alike that consumers who fill prescriptions abroad may receive the wrong active ingredient as the result of pharmacy errors.5 For example, Ambyen is a brand name for amiodarone, used to treat abnormal heart rhythms, in the United Kingdom. A supply of Amyben in place of Ambien (zolpidem tartrate), a sleeping medicine marketed in the U.S., could have a serious adverse outcome. These very similar sounding brand names and the associated active ingredients are listed in Table 2 below, though this list is likely incomplete.

The similarities between the U.S. and foreign names listed in Table 2 may contribute to potentially harmful pharmacy errors. Using a computer algorithm, FDA compared the degree of similarity of drug names listed in Table 2 with the degree of similarity of drug names that ISMP reported were actually confused by pharmacists and doctors in the U.S.6 The drug name pairs in Table 2 are much more similar than those for which ISMP has reported that a patient received the wrong drug because of drug name confusion. This advisory complements the ISMP study data findings. FDA plans to update this advisory, as appropriate, after it collects more information.

 

Table 1
Identical U.S. and Foreign Brand Names Associated With Different Active Ingredients
Brand NameU.S. Active IngredientU.S. IndicationForeign Active IngredientForeign IndicationForeign Country
Aldactonespironolactonewater pillPotassium canrenoatewater pillAustria, Czech Republic, Germany, Hungary
Alphadine*povidone-iodinedisinfectantRanitidineulcerGreece
  Antagon*  ganirelix  fertilityAstemizoleallergiesMexico
RanitidineulcerBrazil
Calanverapamilheart conditionsVinpocetinestroke symptomsJapan
Cervidildinoprostonelabor inductionGemeprostlabor inductionItaly
Clodermclocortolone pivalatedry, itchy skinClotrimazolefungal skin infectionsGermany
Diasorbactivated attapulgitediarrheaLoperamidediarrheaU.K.
  Dilacor  diltiazem  heart conditionsDigoxinheart failureSerbia
Verapamilheart conditionsBrazil
Barnidipineblood pressureArgentina
Flomaxtamsulosinenlarged prostateMorniflumateanti-inflammatoryItaly
Hexalen*altretamineovarian cancerHexetidineantiseptic mouthwashGreece
Naqua**trichlormethiazidewater pillFurosemidewater pillPortugal
NorpramindesipraminedepressionOmeprazoleulcerSpain
Rubexdoxorubicincancerascorbic acidvitamin C deficiencyIreland
Urexmethenamineurinary tract infectionFurosemidewater pillAustralia
Vivelle*estradiolhormone replacementnorgestimate, ethinylestradiolbirth controlAustria

 

*These products have different dosage forms, so that use of the wrong drug seems relatively unlikely, although the difference in active ingredients should be noted.
**Naqua was identified based on the Wall Street Journal story on August 6, 2005.

 

 

Table 2
Similar U.S. and Foreign Brand Names Associated With Different Active Ingredients
US Brand NameUS Active
Ingredient
US IndicationForeign Brand NameForeign Active IngredientForeign Indication*Foreign Country
AccuprilQuinapril HCLhigh blood pressureAceprilLisinoprilhigh blood pressureDenmark
AceprilEnalaprilhigh blood pressureHungary, Switzerland
AceprilCaptoprilhigh blood pressureUK
AlbenzaAlbendazoleparasite infectionsAvanzaMirtazapinedepressionAustralia
AllegraFexofenadine HCLallergiesAllegroFrovatriptanheadacheGermany
AllegroFluticasone ProprionateallergiesIsrael
Allegra DFexofenadine HCL; Pseudoephedrine HCLallergies/cold symptomsAllegroFrovatriptanheadacheGermany
AllegroFluticasone ProprionateallergiesIsrael
AralenChloroquine PhosphatemalariaOralonPovidone-IodinedisinfectantJapan
ParalenParacetamolmild to moderate painCzech Republic
AvandiaRosiglitazone MaleatediabetesAvanzaMirtazapinedepressionAustralia
BetaganLevobunolol HCLglaucomaBetagonMepindololglaucomaItaly
Beta-ValBetamethasone Valerateskin problemsBetanolMetipranololglaucomaMonaco
BetimolTimololglaucomaBetanolMetipranololglaucomaMonaco
CaracFluorouracilcancerCaraceLisinoprilhigh blood pressureIreland, UK
CardeneNicardipine HCLhigh blood pressure, chest painCardemCeliprololhigh blood pressure, chest painSpain
CardinMethyldopahigh blood pressureBrazil
CardizemDiltiazem HCLhigh blood pressure, chest painCardemCeliprololhigh blood pressure, chest painSpain
CedaxCeftibuten DihydrateinfectionCodexSaccharomyces BoulardiiGI disordersItaly
CefotanCefotetan DisodiuminfectionLexotanBromazepamanxietyAustralia, Belgium, Brazil, Denmark, Hong Kong, Ireland, Italy, Mexico, Portugal, Singapore, South Africa, Thailand, UK
CefitonCefiximeinfectionPortugal
CeftinCefuroxime AxetilinfectionCefitonCefiximeinfectionPortugal
CeftinaCefalotininfectionMexico
CeftimCeftazidimeinfectionItaly
CenestinEstrogens; Conjugated SyntheticmenopauseCanestenClotrimazolefungal infectionsAustralia, Austria, Brazil, Canada, Chile, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Thailand, UK
ClobexClobetasol Propionateskin problemsCodexSaccharomyces BoulardiiGI disordersItaly
CognexTacrine HCLAlzheimer's diseaseCodexSaccharomyces BoulardiiGI disordersItaly
DepenPenicillamineWilson's disease, rheumatoid arthritisDeponParacetamolpain, feverGreece
DipenDiltiazemhigh blood pressure, chest painGreece
DesferalDeferoxamine Mesylatelower blood ironDeserilMethysergidemigrainesAustralia, Belgium, Germany, Ireland, Netherlands, Norway, South Africa, Spain, Switzerland, UK
DesyrelTrazodone HCLdepressionDesurolOxolinic Acidurinary tract infectionsCzech Republic
DeserilMethysergidemigrainesAustralia, Belgium, Germany, Ireland, Netherlands, Norway, South Africa, Spain, Switzerland, UK
DetrolTolterodine Tartratebladder controlDesurolOxolinic Acidurinary tract infectionsCzech Republic
DidrexBenzphetamine HCLappetite suppressionNitrexIsosorbide Mononitratechest painItaly
DilantinPhenytoinseizuresDolantinePethidine Hclrelieves moderate to severe pain, including labor painBelgium, Switzerland
DilorDiphyllineasthma, bronchitis, emphysemaDilarParamethasoneinflammationFrance, Mexico
DiurilChlorothiazideblood pressure, swelling associated with heart & liver failureDuorolParacetamolpain, feverSpain
DoxilDoxorubicin HCLcancerDoxalDoxepindepression, anxiety, insomniaFinland
DoxalDoyxcyclineinfectionAustria
DoxalPyridoxine Hcl, Thiamine HclvitaminBrazil
EpipenEpinephrinesevere allergic reactionEpigenGlycyrrhizinic Acidherpes infectionsMexico
   EpopenEpoetin Alfablood lossSpain
EstringEstradiolmenopauseEstrenaEstradiolmenopauseFinland
EstroneEstronemenopauseEstrenaEstradiolmenopauseFinland
EuraxCrotamitonscabies skin infectionUrexFurosemideswelling caused by congestive heart failure, liver disease, or kidney disease.Australia
FlarexFluorometholone Acetatered, watery eyesFluretsSodium Fluoridecavity preventionAustralia
FluarixVaccine, Influenzainfluenza preventionArgentina, Australia, Austria, Brazil, Chile, Czech Republic, Denmark, Finland, France, Greece, Hong Kong, Ireland, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, UK
FluorexSodium Fluoridecavity preventionFrance
FlomaxTamsulosin HCLenlarged prostateFlomoxCefcapene Pivoxil HclinfectionJapan
FloroneDiflorasone Diacetateskin disordersFluoronFluorinecavity preventionCanada
FluoronFluorinecavity preventionCanada
FlogeneFentiazacpain, inflammationItaly
FlogenePiroxicam Betadexpain, inflammationBrazil
Florone-EDiflorasone Diacetateskin disordersFluoronFluorinecavity preventionCanada
FloventFluticasone PropionateasthmaFlogenNaproxenpain, inflammationMexico
FloxinOfloxacininfectionFlogenNaproxenpain, inflammationMexico
FluoxinFluoxetinedepressionCzech Republic
FlexinOrphenadrine Citratemuscle spasmIsrael
Fluor-OpFluorometholonered, watery eyesFluoronFluorinecavity preventionCanada
ForadilFormoterol FumarateasthmaTheradolTramadolpainNetherlands
FosamaxAlendronate Sodiumosteoporosis (thinning of the bone)FisamoxAmoxicillininfectionAustralia
GenotropinSomatropin Recombinantgrowth problemsGenatropineAtropinedigestion problemsFrance
HydreaHydroxyureacancerHydraIsoniazidtuberculosisJapan
HytoneHydrocortisoneskin disordersHysoneHydrocortisoneadrenal insufficiency, inflammationAustralia
ImitrexSumatriptanheadacheNitrexIsosorbide Mononitratechest painItaly
InderalPropranolol HCLhigh blood pressureIndiaralLoperamidediarrheaFrance
Inderal LaPropranolol HCLhigh blood pressureIndiaralLoperamidediarrheaFrance
KionexSodium Polystyrene Sulfonatelower blood potassiumKinexBiperidenParkinson's DiseaseMexico
LamisilTerbinafinefungal infectionsLemesilNimesulidepain, inflammationGreece
LanoxinDigoxinheart failureLemoxinCefuroximeinfectionMexico
LimoxinAmoxicillininfectionMexico
LevatolPenbutolol Sulfatehigh blood pressureLovacolLovastatinhigh cholesterolChile, Finland
LidopenLidocaine HCLanesthetic (numbs body to pain)LinotenPamidronate Disodiumstop bone lossSpain
LincocinLincomycin HCLinfectionLidosenLidocainelocal anesthesiaItaly
LimoxinAmoxicillininfectionMexico
LivostinLevocabastine HCLeye allergiesLimoxinAmoxicillininfectionMexico
LovastinLovastatinhigh cholesterolMalaysia
LodosynCarbidopaParkinson's diseaseLidosenLidocainelocal anesthesiaItaly
LomotilAtropine Sulfate; Diphenoxylate HCLdiarrheaLemesilNimesulidepain, inflammationGreece
LonitenMinoxidilhigh blood pressureLinotenPamidronate Disodiumstop bone lossSpain
LonoxAtropine Sulfate; Diphenoxylate HCLdiarrheaFlomoxCefcapene Pivoxil HclinfectionJapan
LotemaxLoteprednol Etabonateinflammation (swelling)LotanaxTerfenadineallergies and respiratory system disordersCzech Republic
LotensinBenazepril HCLhigh blood pressureLatensinBacillus CereusimmunotherapyGermany
LotronexAlosetron HCLdiarrhea predominate irritable bowel syndromeLotanaxTerfenadineallergies and respiratory system disordersCzech Republic
LovenoxEnoxaparin Sodiumblood clotsLotanaxTerfenadineallergies and respiratory system disordersCzech Republic
LoxitaneLoxapine SuccinateanxietyLexotanBromazepamanxietyAustralia, Belgium, Brazil, Denmark, Hong Kong, Ireland, Italy, Mexico, Portugal, Singapore, South Africa, Thailand, UK
MacrobidNitrofurantoinurinary tract infectionsMikrozidEthanol, PropanoldisinfectantUK
MedrolMethylprednisolonerash, inflammationMedralOmeprazoleulcerMexico
MicrozideHydrochlorothiazidehigh blood pressureNitrobideIsosorbide Dinitratechest painJapan
MikrozidEthanol, PropanoldisinfectantUK
MiralaxPolyethylene Glycol 3350constipationMurelaxOxazepamanxietyAustralia
ModerilRescinnaminehigh blood pressureNoverilDibenzepindepression, bed-wettingAustria, Belgium, Czech Republic, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Switzerland
MycelexClotrimazolefungal skin infectionMucolexCarbocisteinechronic bronchitisIreland, Portugal, Thailand
MucolexGuaifenesinproductive coughHong Kong
NarcanNaloxone HCLnarcotic overdoseMarcenKetazolamanxiety, insomnia, skeletal muscle spasmSpain
NatrecorNesiritide Recombinantsevere congestive heart failureNitrocorGlyceryl Trinitratechest painChile, Italy
NiacorNiacinvitamin deficiencyNacorEnalaprilhigh blood pressureSpain
NipentPentostatinleukemiaNipinNifedipinehigh blood pressure, chest painItaly, Singapore
Nitro-DurNitroglycerinchest painNitrocorGlyceryl Trinitratechest painChile, Italy
NortrelEthinyl Estradiol; Norethindronebirth controlNostrilChlorhexidine; Cetrimoniumdisinfectant mouthwashFrance
NutracortHydrocortisoneskin problemsNitrocorGlyceryl Trinitratechest painChile, Italy
OptivarAzelastine HCLred, watery eyesOpthavirAciclovirchickenpox, shingles, herpes virus infectionsMexico
OraloneTriamcinolone Acetonidemouth ulcersOralonPovidone-IodinedisinfectantJapan
PamineMethscopolamine BromideulcerPeminePenicillamineinflammatory diseaseItaly
PatanolOlopatadine HCLred, watery eyesBetanolMetipranololglaucomaMonaco
PrecoseAcarbosediabetesPrecosaSaccharomyces Boulardiidiarrhea from antibioticsDenmark, Finland, Norway, Sweden
ProlixinFluphenazine HCLmental illnessProlixanAzapropazoneinflammatory diseaseAustria, Germany, Greece, Hungary, Netherlands, Portugal, Switzerland
ProtonixPantoprazole SodiumheartburnPretanixIndapamidehigh blood pressureHungary
ProzacFluoxetine HCLdepressionPrazacPrazosinhigh blood pressureDenmark
RemeronMirtazapinedepressionReneuronFluoxetinedepression, bulimia, obsessive-compulsive disorderSpain
RenagelSevelamer HCLlower blood phosphateRemegelCalcium Carbonateacid indigestion and heartburnIreland, Italy, UK
RenovaTretinoinacneRemovNimesulidepain, inflammationItaly
RevexNalmefene HCLnarcotic overdoseBrivexBrivudineviral infectionsSwitzerland
RubexAscorbic Acidvitamin C deficiencyIreland
SalagenPilocarpine HCLdry mouthPolagenGrass Pollen Extractallergen immunotherapyPortugal
SkelidTiludronate DisodiumPaget's disease of the boneSkaeludPyrithione Zincskin disorders, dandruffDenmark
SpectracefCefditoren PivoxilinfectionSpectrocefCefotaximeinfectionItaly
SpectrobidBacampicillin HCLinfectionSpectrocefCefotaximeinfectionItaly
SymmetrelAmantadine HCLinfluenza (flu) infections (type A)SomatrelSomatorelintest for growth hormone deficiencyDenmark
TalacenAcetaminophen; Pentazocine HCLmild to moderate painTallitonCarvedilolheart failureHungary
TenexGuanfacine HCLhigh blood pressureKinexBiperidenParkinson's DiseaseMexico
Terazol 3Terconazolefungal infectionsTheradolTramadolpainNetherlands
Terazol 7Terconazolefungal infectionsTheradolTramadolpainNetherlands
TetrexTetracycline Phosphate ComplexinfectionNitrexIsosorbide Mononitratechest painItaly
ThalomidThalidomideleprosyThilomideLodoxamide Trometamolred, watery eyesGreece
TiazacDiltiazem HCLhigh blood pressure, chest painTazacNizatidineulcerAustralia
ToradolKetorolac Tromethaminemoderately severe painTheradolTramadolpainNetherlands
TrexallMethotrexate Sodiumcancer, psoriasis, and rheumatoid arthritisTruxalChlorprothixene Hclmental illnessBelgium
TrexolTramadolpainMexico
TriacetTriamcinolone Acetonideallergies, inflammationTriatecRamiprilhigh blood pressureBrazil, Chile, Denmark, France, Italy, Norway, Portugal, Sweden, Switzerland, Greece
VigamoxMoxifloxacin HCLeye infectionsFisamoxAmoxicillininfectionAustralia
VistarilHydroxyzine HCL Or PamoateallergiesVastarelTrimetazidinechest painArgentina, Austria, Brazil, Denmark, France, Greece, Hong Kong, Ireland, Italy, Malaysia, Portugal, Singapore, Thailand
ZestrilLisinoprilhigh blood pressureNostrilChlorhexidine; Cetrimoniumdisinfectant mouthwashFrance

Footnotes:

1 Verispan LLC, Vector One (TM) National, Years Q3/2005, Data Extracted 11-2005. FDA believes that use of brand names in writing prescription is higher for drugs for which no generic is available and lower for drugs commonly sold as generic products.

2 One example is the insomnia treatment Sominex, an over-the-counter medication, which has diphenhydramine as the active ingredient in the U.S. and promethazine as the active ingredient in the U.K.

3 IMS Health, IMS Chemindex(TM) 2003 For additional information see http://www.imshealth.com/web/product/0,3155,64576068_63872702_70297674_71263626.00.html

4 One drug from the list published in the Wall Street Journal, Sominex, was not included because it is available over-the-counter in the U.S.

5 To compile this list of look-alike or sound-alike names, FDA used IMS' Chemindex and a phonetic-coding algorithm to rank pairs of drug names by their similarity. FDA then refined the list by removing any potentially confusing foreign products that also had an identical U.S. counterpart (same brand name, same active ingredient). FDA also deleted any products that FDA pharmacists determined were invalid or inappropriate (e.g., brand names like "Pain Reliever" or "Decongestant" and some dietary supplements).  FDA then identified those products for which the brand names were so similar that FDA would have asked for more information about the foreign name before approving it for use in the U.S.

6 See http://www.ismp.org/Tools/confuseddrugnames.pdf