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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.
Brand Name | U.S. Active Ingredient | U.S. Indication | Foreign Active Ingredient | Foreign Indication | Foreign Country |
---|---|---|---|---|---|
Aldactone | spironolactone | water pill | Potassium canrenoate | water pill | Austria, Czech Republic, Germany, Hungary |
Alphadine* | povidone-iodine | disinfectant | Ranitidine | ulcer | Greece |
Antagon* | ganirelix | fertility | Astemizole | allergies | Mexico |
Ranitidine | ulcer | Brazil | |||
Calan | verapamil | heart conditions | Vinpocetine | stroke symptoms | Japan |
Cervidil | dinoprostone | labor induction | Gemeprost | labor induction | Italy |
Cloderm | clocortolone pivalate | dry, itchy skin | Clotrimazole | fungal skin infections | Germany |
Diasorb | activated attapulgite | diarrhea | Loperamide | diarrhea | U.K. |
Dilacor | diltiazem | heart conditions | Digoxin | heart failure | Serbia |
Verapamil | heart conditions | Brazil | |||
Barnidipine | blood pressure | Argentina | |||
Flomax | tamsulosin | enlarged prostate | Morniflumate | anti-inflammatory | Italy |
Hexalen* | altretamine | ovarian cancer | Hexetidine | antiseptic mouthwash | Greece |
Naqua** | trichlormethiazide | water pill | Furosemide | water pill | Portugal |
Norpramin | desipramine | depression | Omeprazole | ulcer | Spain |
Rubex | doxorubicin | cancer | ascorbic acid | vitamin C deficiency | Ireland |
Urex | methenamine | urinary tract infection | Furosemide | water pill | Australia |
Vivelle* | estradiol | hormone replacement | norgestimate, ethinylestradiol | birth control | Austria |
*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.
US Brand Name | US Active Ingredient |
US Indication | Foreign Brand Name | Foreign Active Ingredient | Foreign Indication* | Foreign Country |
---|---|---|---|---|---|---|
Accupril | Quinapril HCL | high blood pressure | Acepril | Lisinopril | high blood pressure | Denmark |
Acepril | Enalapril | high blood pressure | Hungary, Switzerland | |||
Acepril | Captopril | high blood pressure | UK | |||
Albenza | Albendazole | parasite infections | Avanza | Mirtazapine | depression | Australia |
Allegra | Fexofenadine HCL | allergies | Allegro | Frovatriptan | headache | Germany |
Allegro | Fluticasone Proprionate | allergies | Israel | |||
Allegra D | Fexofenadine HCL; Pseudoephedrine HCL | allergies/cold symptoms | Allegro | Frovatriptan | headache | Germany |
Allegro | Fluticasone Proprionate | allergies | Israel | |||
Aralen | Chloroquine Phosphate | malaria | Oralon | Povidone-Iodine | disinfectant | Japan |
Paralen | Paracetamol | mild to moderate pain | Czech Republic | |||
Avandia | Rosiglitazone Maleate | diabetes | Avanza | Mirtazapine | depression | Australia |
Betagan | Levobunolol HCL | glaucoma | Betagon | Mepindolol | glaucoma | Italy |
Beta-Val | Betamethasone Valerate | skin problems | Betanol | Metipranolol | glaucoma | Monaco |
Betimol | Timolol | glaucoma | Betanol | Metipranolol | glaucoma | Monaco |
Carac | Fluorouracil | cancer | Carace | Lisinopril | high blood pressure | Ireland, UK |
Cardene | Nicardipine HCL | high blood pressure, chest pain | Cardem | Celiprolol | high blood pressure, chest pain | Spain |
Cardin | Methyldopa | high blood pressure | Brazil | |||
Cardizem | Diltiazem HCL | high blood pressure, chest pain | Cardem | Celiprolol | high blood pressure, chest pain | Spain |
Cedax | Ceftibuten Dihydrate | infection | Codex | Saccharomyces Boulardii | GI disorders | Italy |
Cefotan | Cefotetan Disodium | infection | Lexotan | Bromazepam | anxiety | Australia, Belgium, Brazil, Denmark, Hong Kong, Ireland, Italy, Mexico, Portugal, Singapore, South Africa, Thailand, UK |
Cefiton | Cefixime | infection | Portugal | |||
Ceftin | Cefuroxime Axetil | infection | Cefiton | Cefixime | infection | Portugal |
Ceftina | Cefalotin | infection | Mexico | |||
Ceftim | Ceftazidime | infection | Italy | |||
Cenestin | Estrogens; Conjugated Synthetic | menopause | Canesten | Clotrimazole | fungal infections | Australia, 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 |
Clobex | Clobetasol Propionate | skin problems | Codex | Saccharomyces Boulardii | GI disorders | Italy |
Cognex | Tacrine HCL | Alzheimer's disease | Codex | Saccharomyces Boulardii | GI disorders | Italy |
Depen | Penicillamine | Wilson's disease, rheumatoid arthritis | Depon | Paracetamol | pain, fever | Greece |
Dipen | Diltiazem | high blood pressure, chest pain | Greece | |||
Desferal | Deferoxamine Mesylate | lower blood iron | Deseril | Methysergide | migraines | Australia, Belgium, Germany, Ireland, Netherlands, Norway, South Africa, Spain, Switzerland, UK |
Desyrel | Trazodone HCL | depression | Desurol | Oxolinic Acid | urinary tract infections | Czech Republic |
Deseril | Methysergide | migraines | Australia, Belgium, Germany, Ireland, Netherlands, Norway, South Africa, Spain, Switzerland, UK | |||
Detrol | Tolterodine Tartrate | bladder control | Desurol | Oxolinic Acid | urinary tract infections | Czech Republic |
Didrex | Benzphetamine HCL | appetite suppression | Nitrex | Isosorbide Mononitrate | chest pain | Italy |
Dilantin | Phenytoin | seizures | Dolantine | Pethidine Hcl | relieves moderate to severe pain, including labor pain | Belgium, Switzerland |
Dilor | Diphylline | asthma, bronchitis, emphysema | Dilar | Paramethasone | inflammation | France, Mexico |
Diuril | Chlorothiazide | blood pressure, swelling associated with heart & liver failure | Duorol | Paracetamol | pain, fever | Spain |
Doxil | Doxorubicin HCL | cancer | Doxal | Doxepin | depression, anxiety, insomnia | Finland |
Doxal | Doyxcycline | infection | Austria | |||
Doxal | Pyridoxine Hcl, Thiamine Hcl | vitamin | Brazil | |||
Epipen | Epinephrine | severe allergic reaction | Epigen | Glycyrrhizinic Acid | herpes infections | Mexico |
Epopen | Epoetin Alfa | blood loss | Spain | |||
Estring | Estradiol | menopause | Estrena | Estradiol | menopause | Finland |
Estrone | Estrone | menopause | Estrena | Estradiol | menopause | Finland |
Eurax | Crotamiton | scabies skin infection | Urex | Furosemide | swelling caused by congestive heart failure, liver disease, or kidney disease. | Australia |
Flarex | Fluorometholone Acetate | red, watery eyes | Flurets | Sodium Fluoride | cavity prevention | Australia |
Fluarix | Vaccine, Influenza | influenza prevention | Argentina, 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 | |||
Fluorex | Sodium Fluoride | cavity prevention | France | |||
Flomax | Tamsulosin HCL | enlarged prostate | Flomox | Cefcapene Pivoxil Hcl | infection | Japan |
Florone | Diflorasone Diacetate | skin disorders | Fluoron | Fluorine | cavity prevention | Canada |
Fluoron | Fluorine | cavity prevention | Canada | |||
Flogene | Fentiazac | pain, inflammation | Italy | |||
Flogene | Piroxicam Betadex | pain, inflammation | Brazil | |||
Florone-E | Diflorasone Diacetate | skin disorders | Fluoron | Fluorine | cavity prevention | Canada |
Flovent | Fluticasone Propionate | asthma | Flogen | Naproxen | pain, inflammation | Mexico |
Floxin | Ofloxacin | infection | Flogen | Naproxen | pain, inflammation | Mexico |
Fluoxin | Fluoxetine | depression | Czech Republic | |||
Flexin | Orphenadrine Citrate | muscle spasm | Israel | |||
Fluor-Op | Fluorometholone | red, watery eyes | Fluoron | Fluorine | cavity prevention | Canada |
Foradil | Formoterol Fumarate | asthma | Theradol | Tramadol | pain | Netherlands |
Fosamax | Alendronate Sodium | osteoporosis (thinning of the bone) | Fisamox | Amoxicillin | infection | Australia |
Genotropin | Somatropin Recombinant | growth problems | Genatropine | Atropine | digestion problems | France |
Hydrea | Hydroxyurea | cancer | Hydra | Isoniazid | tuberculosis | Japan |
Hytone | Hydrocortisone | skin disorders | Hysone | Hydrocortisone | adrenal insufficiency, inflammation | Australia |
Imitrex | Sumatriptan | headache | Nitrex | Isosorbide Mononitrate | chest pain | Italy |
Inderal | Propranolol HCL | high blood pressure | Indiaral | Loperamide | diarrhea | France |
Inderal La | Propranolol HCL | high blood pressure | Indiaral | Loperamide | diarrhea | France |
Kionex | Sodium Polystyrene Sulfonate | lower blood potassium | Kinex | Biperiden | Parkinson's Disease | Mexico |
Lamisil | Terbinafine | fungal infections | Lemesil | Nimesulide | pain, inflammation | Greece |
Lanoxin | Digoxin | heart failure | Lemoxin | Cefuroxime | infection | Mexico |
Limoxin | Amoxicillin | infection | Mexico | |||
Levatol | Penbutolol Sulfate | high blood pressure | Lovacol | Lovastatin | high cholesterol | Chile, Finland |
Lidopen | Lidocaine HCL | anesthetic (numbs body to pain) | Linoten | Pamidronate Disodium | stop bone loss | Spain |
Lincocin | Lincomycin HCL | infection | Lidosen | Lidocaine | local anesthesia | Italy |
Limoxin | Amoxicillin | infection | Mexico | |||
Livostin | Levocabastine HCL | eye allergies | Limoxin | Amoxicillin | infection | Mexico |
Lovastin | Lovastatin | high cholesterol | Malaysia | |||
Lodosyn | Carbidopa | Parkinson's disease | Lidosen | Lidocaine | local anesthesia | Italy |
Lomotil | Atropine Sulfate; Diphenoxylate HCL | diarrhea | Lemesil | Nimesulide | pain, inflammation | Greece |
Loniten | Minoxidil | high blood pressure | Linoten | Pamidronate Disodium | stop bone loss | Spain |
Lonox | Atropine Sulfate; Diphenoxylate HCL | diarrhea | Flomox | Cefcapene Pivoxil Hcl | infection | Japan |
Lotemax | Loteprednol Etabonate | inflammation (swelling) | Lotanax | Terfenadine | allergies and respiratory system disorders | Czech Republic |
Lotensin | Benazepril HCL | high blood pressure | Latensin | Bacillus Cereus | immunotherapy | Germany |
Lotronex | Alosetron HCL | diarrhea predominate irritable bowel syndrome | Lotanax | Terfenadine | allergies and respiratory system disorders | Czech Republic |
Lovenox | Enoxaparin Sodium | blood clots | Lotanax | Terfenadine | allergies and respiratory system disorders | Czech Republic |
Loxitane | Loxapine Succinate | anxiety | Lexotan | Bromazepam | anxiety | Australia, Belgium, Brazil, Denmark, Hong Kong, Ireland, Italy, Mexico, Portugal, Singapore, South Africa, Thailand, UK |
Macrobid | Nitrofurantoin | urinary tract infections | Mikrozid | Ethanol, Propanol | disinfectant | UK |
Medrol | Methylprednisolone | rash, inflammation | Medral | Omeprazole | ulcer | Mexico |
Microzide | Hydrochlorothiazide | high blood pressure | Nitrobide | Isosorbide Dinitrate | chest pain | Japan |
Mikrozid | Ethanol, Propanol | disinfectant | UK | |||
Miralax | Polyethylene Glycol 3350 | constipation | Murelax | Oxazepam | anxiety | Australia |
Moderil | Rescinnamine | high blood pressure | Noveril | Dibenzepin | depression, bed-wetting | Austria, Belgium, Czech Republic, Germany, Hungary, Israel, Italy, Netherlands, South Africa, Switzerland |
Mycelex | Clotrimazole | fungal skin infection | Mucolex | Carbocisteine | chronic bronchitis | Ireland, Portugal, Thailand |
Mucolex | Guaifenesin | productive cough | Hong Kong | |||
Narcan | Naloxone HCL | narcotic overdose | Marcen | Ketazolam | anxiety, insomnia, skeletal muscle spasm | Spain |
Natrecor | Nesiritide Recombinant | severe congestive heart failure | Nitrocor | Glyceryl Trinitrate | chest pain | Chile, Italy |
Niacor | Niacin | vitamin deficiency | Nacor | Enalapril | high blood pressure | Spain |
Nipent | Pentostatin | leukemia | Nipin | Nifedipine | high blood pressure, chest pain | Italy, Singapore |
Nitro-Dur | Nitroglycerin | chest pain | Nitrocor | Glyceryl Trinitrate | chest pain | Chile, Italy |
Nortrel | Ethinyl Estradiol; Norethindrone | birth control | Nostril | Chlorhexidine; Cetrimonium | disinfectant mouthwash | France |
Nutracort | Hydrocortisone | skin problems | Nitrocor | Glyceryl Trinitrate | chest pain | Chile, Italy |
Optivar | Azelastine HCL | red, watery eyes | Opthavir | Aciclovir | chickenpox, shingles, herpes virus infections | Mexico |
Oralone | Triamcinolone Acetonide | mouth ulcers | Oralon | Povidone-Iodine | disinfectant | Japan |
Pamine | Methscopolamine Bromide | ulcer | Pemine | Penicillamine | inflammatory disease | Italy |
Patanol | Olopatadine HCL | red, watery eyes | Betanol | Metipranolol | glaucoma | Monaco |
Precose | Acarbose | diabetes | Precosa | Saccharomyces Boulardii | diarrhea from antibiotics | Denmark, Finland, Norway, Sweden |
Prolixin | Fluphenazine HCL | mental illness | Prolixan | Azapropazone | inflammatory disease | Austria, Germany, Greece, Hungary, Netherlands, Portugal, Switzerland |
Protonix | Pantoprazole Sodium | heartburn | Pretanix | Indapamide | high blood pressure | Hungary |
Prozac | Fluoxetine HCL | depression | Prazac | Prazosin | high blood pressure | Denmark |
Remeron | Mirtazapine | depression | Reneuron | Fluoxetine | depression, bulimia, obsessive-compulsive disorder | Spain |
Renagel | Sevelamer HCL | lower blood phosphate | Remegel | Calcium Carbonate | acid indigestion and heartburn | Ireland, Italy, UK |
Renova | Tretinoin | acne | Remov | Nimesulide | pain, inflammation | Italy |
Revex | Nalmefene HCL | narcotic overdose | Brivex | Brivudine | viral infections | Switzerland |
Rubex | Ascorbic Acid | vitamin C deficiency | Ireland | |||
Salagen | Pilocarpine HCL | dry mouth | Polagen | Grass Pollen Extract | allergen immunotherapy | Portugal |
Skelid | Tiludronate Disodium | Paget's disease of the bone | Skaelud | Pyrithione Zinc | skin disorders, dandruff | Denmark |
Spectracef | Cefditoren Pivoxil | infection | Spectrocef | Cefotaxime | infection | Italy |
Spectrobid | Bacampicillin HCL | infection | Spectrocef | Cefotaxime | infection | Italy |
Symmetrel | Amantadine HCL | influenza (flu) infections (type A) | Somatrel | Somatorelin | test for growth hormone deficiency | Denmark |
Talacen | Acetaminophen; Pentazocine HCL | mild to moderate pain | Talliton | Carvedilol | heart failure | Hungary |
Tenex | Guanfacine HCL | high blood pressure | Kinex | Biperiden | Parkinson's Disease | Mexico |
Terazol 3 | Terconazole | fungal infections | Theradol | Tramadol | pain | Netherlands |
Terazol 7 | Terconazole | fungal infections | Theradol | Tramadol | pain | Netherlands |
Tetrex | Tetracycline Phosphate Complex | infection | Nitrex | Isosorbide Mononitrate | chest pain | Italy |
Thalomid | Thalidomide | leprosy | Thilomide | Lodoxamide Trometamol | red, watery eyes | Greece |
Tiazac | Diltiazem HCL | high blood pressure, chest pain | Tazac | Nizatidine | ulcer | Australia |
Toradol | Ketorolac Tromethamine | moderately severe pain | Theradol | Tramadol | pain | Netherlands |
Trexall | Methotrexate Sodium | cancer, psoriasis, and rheumatoid arthritis | Truxal | Chlorprothixene Hcl | mental illness | Belgium |
Trexol | Tramadol | pain | Mexico | |||
Triacet | Triamcinolone Acetonide | allergies, inflammation | Triatec | Ramipril | high blood pressure | Brazil, Chile, Denmark, France, Italy, Norway, Portugal, Sweden, Switzerland, Greece |
Vigamox | Moxifloxacin HCL | eye infections | Fisamox | Amoxicillin | infection | Australia |
Vistaril | Hydroxyzine HCL Or Pamoate | allergies | Vastarel | Trimetazidine | chest pain | Argentina, Austria, Brazil, Denmark, France, Greece, Hong Kong, Ireland, Italy, Malaysia, Portugal, Singapore, Thailand |
Zestril | Lisinopril | high blood pressure | Nostril | Chlorhexidine; Cetrimonium | disinfectant mouthwash | France |
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.