CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`2 1 -92 6
`
`I PROPRIETARY NAME REVIEW! S)
`
`

`

`
`
`Department of Health and Human Services
`
`Public Health Service
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Office of Surveillance and Epidemiology
`
`Date:
`
`To:
`
`Thru:
`
`From:
`
`Subject:
`
`Drug Name:
`
`April 14, 2008
`
`Russell Katz, MD, Director
`Division of Neurology Products, HFD-120
`
`Linda Y. Kim-Jung, PharmD, Team Leader
`Denise P. Toyer, PharmD, Deputy Director
`Carol A. Holquist, R.Ph., Director
`Division of Medication Error Prevention, HFD-420
`
`Loretta Holmes, BSN, PharmD, Safety Evaluator
`Division of Medication Error Prevention, HFD—420
`
`Proprietary Name, Label, and Labeling Review
`
`Treximet (Sumatriptan and Naproxen Sodium) Tablets
`85 mg/SOO mg
`
`Application Type/Number: NDA 21-926
`
`Applicant:
`
`Pozen, Inc.
`
`OSE RCM #:
`
`2008-433
`
`W Note: This review contains proprietary and confidential information that should not be
`released to the public***
`
`

`

`Contents
`
`I
`
`3
`
`4
`
`EXECUTIVE SUMMARY .......................................................................................................................... 3
`1
`BACKGROUND .................................................................................................................................. 3
`1 . 1
`Introduction................................................................................................................................... 3
`1.2
`Regulatory History ........................................................................................................................ 3
`1.3
`Product Information ...................................................................................................................... 3
`2 METHODS AND MATERIALS .......................................................................................................... 3
`2.1
`Proprietary Name Risk Assessment .............................................................................................. 4
`2.2
`Label and Labeling Risk Assessment ........................................................................................... 8
`RESULTS ............................................................................................................................................. 9
`3.1
`Proprietary Name Risk Assessment .............................................................................................. 9
`3.2
`Label and Labeling Risk Assessment ......................................................................................... 10
`DISCUSSION ..................................................................................................................................... 1 1
`4.1
`Proprietary Name Risk Assessment ............................................................................................ 1 1
`4.2
`Label and Labeling Risk Assessment ......................................................................................... 1 1
`CONCLUSIONS ................................................................................................................................. 12
`RECOMMENDATIONS .................................................................................................................... 13
`6.1
`Comments to the Division........................................................................................................... 13
`6.2
`Comments to the Applicant......................................................................................................... l3
`REFERENCES ................................................................................................................................... 14
`7
`APPENDICES ............................................................................................................................................ l 6
`
`5
`6
`
`

`

`EXECUTIVE SUMMARY
`
`The results of the Proprietary Name Risk Assessment found that the proposed name,Treximet, has some
`similarity to other proprietary and established drug names, but the findings of the FMEA indicate that the
`proposed name does not appear to be vulnerable to name confusion that could lead to medication errors.
`Thus, the Division of Medication Error Prevention has no objections to the use of the proprietary name,
`Treximet, for this product.
`
`The results Ofthe Label and Labeling Risk Assessment found that the presentation of the statement of
`strength on the container labels and carton labeling and omission of the drug administration precaution on
`the carton labeling render the labels and labeling vulnerable to confusion that could lead to medication
`errors. The Division of Medication Error Prevention and Analysis believes the risks we have identified
`can be addressed and mitigated prior to drug approval and provide recommendations in Section 6.
`
`However; if any of the proposed product characteristics as stated in this review are altered prior to
`approval of the product, the Division of Medication Error Prevention rescinds this Risk Assessment
`finding, and recommends that the name be resubmitted for review. Additionally, if product approval is
`delayed beyond 90 days from the signature date of this review, the proposed name must be resubmitted
`for re-evaluation.
`
`1
`
`BACKGROUND
`
`1.1
`
`INTRODUCTION 7
`
`This review was written in response to a request from the Division of Neurology Products (HFD—120) for
`re-assessment of the proposed proprietary name, Treximet, regarding potential name confusion with other
`proprietary or established drug names.
`
`1 .2
`
`REGULATORY HISTORY
`
`The Division of Medication Error Prevention previously reviewed the names n (primary) and
`Treximet (secondary) for this NDA (see OSE Review 2007-1571, dated August 16, 2007) and had no
`objections to the use of those names at that time. The Applicant has chosen the secondary name,
`Treximet, for their product.
`
`1.3
`
`PRODUCT INFORMATION
`
`Treximet contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine. (5-HT1) receptor
`subtype agonist, and naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-
`inflammatory drugs. Treximet is indicated for the acute treatment of migraine attacks with or without
`aura in adults. Treximet will be available as 85 mg/SOO mg tablets. The recommended dose is one tablet
`with a maximum dose of two tablets in 24 hours. Dosing of tablets should be at least two hours apart.
`Treximet may be administered with or without food. Tablets should not be split, crushed, or chewed.
`Treximet has a boxed warning in the package insert labeling concerning cardiovascular and
`gastrointestinal risks. The product will be supplied in compact containers of 9 tablets with a specially
`formulated, non—removable dessicant.
`
`2 METHODS AND MATERIALS
`
`This section consists of two sections which describe the methods and materials used by the Division of
`Medication Error Prevention Medication Error Staff conducting a proprietary name risk assessment (see
`2.1 Proprietary Name Risk Assessment). The primary focus for both of the assessments is to identify and
`remedy potential sources of medication error prior to drug approval. The Division of Medication Error
`Prevention defines a medication error as any preventable event that may cause or lead to inappropriate
`
`

`

`medication use or patient harm while the medication is in the control of the health care professional,
`patient, or consumer. I
`
`2.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name, Treximet, and the proprietary and established names of drug products existing in the
`marketplace and those pending IND, NDA, and ANDA products currently under review by the Agency.
`For the proprietary name,Treximet, the Medication Error Staff of the Division of Medication Error
`Prevention search a standard set of databases and information sources to identify names with orthographic
`and phonetic similarity (see Sections 2.1.1 for detail) and held a CDER Expert Panel discussion to gather
`professional opinions on the safety of the proposed proprietary name (see 2.1.1.2). The Division of
`Medication Error Prevention normally conducts internal CDER prescription analysis studies and, when
`provided, external prescription analysis studies results are considered and incorporated into the overall
`risk assessment. However, since this name was previously evaluated, CDER prescription analysis studies
`were not conducted upon re-review of Treximet.
`
`The Safety Evaluator assigned to the Proprietary Name Risk Assessment is responsible for considering
`the collective findings, and provides an overall risk assessment of the proposed proprietary name (see
`detail 2.1.3). The overall risk assessment is based on the findings of a Failure Modes and Effects Analysis
`(FMEA) of the proprietary name, and is focused on the avoidance of medication errors. FMEA is a
`systematic tool for evaluating a process and identifying where and how it might fail.2 FMEA is used to
`analyze whether the drug names identified with look— or sound-alike similarity to the proposed name
`could cause confusion that subsequently leads to medication errors in the clinical setting. The Division of
`Medication Error Prevention uses the clinical expertise of the Medication Error Staff to anticipate the
`conditions of the clinical setting that the product is likely to be used in based on the characteristics of the
`proposed product.
`
`In addition, the product characteristics provide the context for the verbal and written communication of
`the drug names and can interact with the orthographic and phonetic attributes of the names to increase the
`risk of confusion when there is overlap, or, in some instances, decrease the risk of confusion by helping to
`differentiate the products through dissimilarity. As such, the Staff considers the product characteristics
`associated with the proposed drug throughout the risk assessment, since the product characteristics of the
`proposed may provide a context for communication of the drug name and ultimately determine the use of
`the product in the usual clinical practice setting.
`
`Typical product characteristics considered when identifying drug names that could potentially be
`confused with the proposed drug name include, but are not limited to established name of the proposed
`product, the proposed indication, dosage form, route of administration, strength, unit of measure, dosage
`units, recommended dose, typical quantity or volume, frequency of administration, product packaging,
`storage conditions, patient population, and prescriber population. Because drug name confusion can occur
`at any point in the medication use process, the Division of Medication Error Prevention considers the
`potential for confusion throughout the entire US medication use process, including drug procurement,
`prescribing and ordering, dispensing, administration, and monitoring the impact of the medication.3
`
`' National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccme§p.orgzaboutMedErrorshtml. Last accessed 10/11/2007.
`
`2 Institute for Healthcare Improvement (II-II). Failure Modes and Effects Analysis. Boston. II-H:2004.
`3 Institute ofMedicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`
`

`

`2.1.1 Search Criteria
`
`The Medication Error Staff consider the spelling ofthe name, pronunciation ofthe name when spoken,
`and appearance of the name when scripted as outlined in Appendix A.
`
`For this review, particular consideration was given to drug names beginning with the letter ‘T’ when
`searching to identify potentially similar drug names, as 75% of the confused drug names reported by the
`USP-ISMP Medication Error Reporting Program involve pairs beginning with the same letter.45
`
`To identify drug names that may look similar to Treximet, the staff also consider the orthographic
`appearance of the name on lined and unlined orders. Specific attributes taken into consideration include
`the length of the name (8 letters), upstrokes (2, capital letter ‘T’ and lowercase ‘t’), downstrokes (none),
`cross-strokes (2, lowercase ‘x’ and ‘t’), and dotted letters (‘i’). Additionally, several letters in Treximet
`may be vulnerable to ambiguity when scripted, including the letter ‘T’ which may appear as uppercase
`‘F’, ‘L’, and ‘Z’; lower case ‘r’ appear as a lower case ‘n’ or ‘s’; lowercase ‘e’ appear as lowercase
`undotted ‘i’ or ‘1’; lowercase ‘x’ appear as a lowercase ‘f’, ‘k’, ‘n’, ‘p’, ‘r’ or ‘t’; lowercase ‘i’ appear as
`lowercase ‘e’ or ‘1’; lowercase ‘m’ appear as lowercase ‘n’, ‘ss’, or ‘z’; and lowercase ‘t’ appear as
`lowercase ‘f’, ‘k’, or ‘x’. As such, the Staff also consider these alternate appearances when identifying
`drug names that may look similar to Treximet.
`
`When searching to identify potential names that may sound similar to Treximet, the Medication Error
`Staff search for names with similar number of syllables (three), stresses (TREX-i-met, trex-I-met, or
`trex-i-MET), and placement of vowel and consonant sounds. Additionally, “Trex” can sound like “Trac”
`when pronounced. The Sponsor’s intended pronunciation of the proprietary name could not be expressly
`taken into consideration, as this was not provided with the proposed name submission.
`
`The Staff also considers the product characteristics associated with the proposed drug throughout the
`identification of similar drug names, since the product characteristics of the proposed drug ultimately
`determine the use of the product in the clinical practice setting. For this review, the Medication Error
`Staff were provided with the following information about the proposed product:
`the proposed proprietary
`name (Treximet), the established name (sumatriptan and naproxen sodium), proposed indication of use
`(acute treatment of migraine attack), strength (85 mg/SOO mg), dose (one tablet), frequency of
`administration (up to two tablets in a 24 hour period with a minimum of 2 hours between doses), route
`(oral) and dosage form of the product (tablet). Appendix A provides a more detailed listing of the product
`characteristics the Medication Error Staff general take into consideration.
`
`Lastly, the Medication Error Staff also consider the potential for the proposed name to inadvertently
`function as a source of error for reasons other than name confusion. Post-marketing experience has
`demonstrated that proprietary names (or components of the proprietary name) can be a source of error in a
`variety of ways. As such, these broader safety implications of the name are considered and evaluated
`throughout this assessment and the Medication Error Staff provide additional comments related to the
`safety of the proposed name or product based on their professional experience with medication errors.
`
`2.1.1.1 Databases and information sources
`
`The proposed proprietary name, Treximet, was provided to the Medication Error Staff to conduct a search
`of the intemet, several standard published drug product reference texts, and FDA databases to identify
`existing and proposed drug names that may sound-alike or look-alike to Treximet using the criteria
`
`
`4 Institute for Safe Medication Practices. Confiised Drug name List (1996-2006). Available at
`http://www.ismp.org[Tools/confuseddrugnames.pdf
`5 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artifical Inteligence in Medicine
`(2005)
`
`

`

`outlined in 2.1.1. A standard description of the databases used in the searches is provided in Section 7.
`To complement the process, the Medication Error Staff use a computerized method of identifying
`phonetic and orthographic similarity between medication names. The program, Phonetic and
`Orthographic Computer Analysis (POCA), uses complex algorithms to select a list of names from a
`database that have some similarity (phonetic, orthographic, or both) to the trademark being evaluated.
`Lastly, the Medication Error Staff review the USAN stem list to determine if any USAN stems are present
`within the proprietary name. The findings of the individual Safety Evaluators were then pooled and
`presented to the Expert Panel.
`
`2.1.1.2 CDER Expert Panel Discussion
`
`An Expert Panel Discussion is held by the Division of Medication Error Prevention to gather CDER
`professional opinions on the safety of the product and the proprietary name, Treximet. Potential concerns
`regarding drug marketing and promotion related to the proposed names are also discussed. This group is
`composed of the Division of Medication Error Prevention Staff and representatives from the Division of
`Drug Marketing, Advertising, and Communications (DDMAC).
`
`The pooled results of the Medication Error Staff were presented to the Expert Panel for consideration.
`Based on the clinical and professional experiences of the Expert Panel members, the Panel may
`recommend the addition of names, additional searches by the Safety Evaluator to supplement the pooled
`results, or general advice to consider when reviewing the proposed proprietary name.
`
`2.1.2 Safety Evaluator Risk Assessment ofthe Proposed Proprietary Name
`
`Based on the criteria set forth in Section 2.1.1, the Safety Evaluator applies their individual expertise
`gained from evaluating medication errors reported to FDA to conduct a Failure Modes and Effects
`Analysis and provide an overall risk of name confusion. Failure Mode and Effects Analysis (FMEA) is a
`systematic tool for evaluating a process and identifying where and how it might fail.6 When applying
`FMEA to assess the risk of a proposed proprietary name, we seek to evaluate the potential for a proposed
`name to be confused with another drug name as a result of the name confusion and cause errors to occur
`in the medication use system. FMEA capitalizes on the predictable and preventable nature of medication
`errors associated with drug name confusion. FMEA allows the Agency to identify the potential for
`medication errors due to look— or sound-alike drug names prior to approval, where actions to overcome
`these issues are easier and more effective than remedies available in the post-approval phase.
`
`In order to perform a FMEA of the proposed name, the Safety Evaluator must analyze the use of the
`product at all points in the medication use system. Because the proposed product is not yet marketed, the
`Safety Evaluator anticipates the use of the product in the usual practice settings by considering the clinical
`and product characteristics listed in Appendix A. The Safety Evaluator then analyzes the proposed
`proprietary name in the context of the usual practice setting and works to identify potential failure modes
`and the effects associated with the failure modes.
`
`In the initial stage of the Risk Assessment, the Safety Evaluator compares the proposed proprietary name
`to all of the names gathered from the above searches, expert panel evaluation, and studies, and identifies
`potential failure modes by asking: “Is the name Treximet convincingly similar to another drug name,
`which may cause practitioners to become confused at any point in the usual practice setting?” An
`affirmative answer indicates a failure mode and represents a potential for Tresimet to be confused with
`another proprietary or established drug name because of look- or sound-alike similarity. If the answer to
`the question is no, the Safety Evaluator is not convinced that the names possess similarity that would
`cause confusion at any point in the medication use system and the name is eliminated from further review.
`
`6 Institute for Healthcare Improvement (Hfl). Failure Modes and Effects Analysis. Boston. IPH12004.
`
`

`

`In the second stage of the Risk Assessment, all potential failure modes are evaluated to determine the
`likely efikct of the drug name confusion, by asking “Could the confusion of the drug names conceivably
`result in medication errors in the usual practice setting?” The answer to this question is a central
`component of the Safety Evaluator’s overall risk assessment of the proprietary name. If the Safety
`Evaluator determines through FMEA that the name similarity would ultimately not be a source of
`medication errors in the usual practice setting, the name is eliminated from further analysis. However, if
`the Safety Evaluator determines through FMEA that the name similarity could ultimately cause
`medication errors in the usual practice setting, the Safety Evaluator will then recommend that an alternate
`proprietary name be used. In rare instances, the FMEA findings may provide other risk-reduction
`strategies, such as product reformulation to avoid an overlap in strength or an alternate modifier
`designation may be recommended as a means of reducing the risk of medication errors resulting from
`drug name confusion.
`
`The Division of Medication Error Prevention will object to the use of proposed proprietary name when
`one or more of the following conditions are identified in the Safety Evaluator’s Risk Assessment:
`
`1. DDMAC finds the proposed proprietary name misleading from a promotional perspective, and
`the review Division concurs with DDMAC’s findings. The Federal Food, Drug, and Cosmetic
`Act provides that labeling or advertising can misbrand a product if misleading representations are
`made or suggested by statement, word, design, device, or any combination thereof, whether
`through a trade name or otherwise.
`[21 U.S.C 321(n); see also 21 U.S.C. 352(a) & (n)].
`
`2. The Division of Medication Error Prevention identifies that the proposed proprietary name is
`misleading because of similarity in spelling or pronunciation to another proprietary or established
`name of a different drug or ingredient [CFR 201.10.(C)(5)].
`
`3. FMEA identifies potential for confusion between the proposed proprietary name and other
`proprietary or established drug names, fl demonstrates that medication errors are likely to result
`from the drug name confusion under the conditions of usual clinical practice.
`
`4. The proposed proprietary name contains an USAN stem, particularly in a manner that is
`contradictory to the USAN Council’s definition.
`
`5. Medication Error Staff identify a potential source of medication error within the proposed
`proprietary name. The proprietary name may be misleading, or inadvertently introduce ambiguity
`and confusion that leads to errors. Such errors may not necessarily involve confusion between
`the proposed drug another drug product.
`
`In the event that the Division of Medication Error Prevention object to the use of the proposed proprietary
`name, based upon the potential for confusion with another proposed (but not yet approved) proprietary
`name, we will provide a contingency objection based on the date of approval: whichever product is
`awarded approval first has the right to the use the name, while we will recommend that the second
`product to reach approval seek an alternative name.
`
`If none of these conditions are met, then we will not object to the use of the proprietary name. If any of
`these conditions are met, then we will object to the use of the proprietary name. The threshold set for
`objection to the proposed proprietary name may seem low to the Sponsor/Applicant; however, the safety
`concerns set forth in criteria 1 through 5 are supported either by FDA Regulation or by external
`healthcare authorities, including the Institute of Medicine, World Health Organization, Joint Commission,
`and Institute for Safe Medication Practices, have examined medication errors resulting from look— or
`sound-alike drug names and called for Regulatory Authorities to address the issue prior to approval.
`
`Furthermore, the Division of Medication Error Prevention contends that the threshold set for the
`Proprietary Name Risk Assessment is reasonable because proprietary drug name confusion is a
`
`

`

`predictable and preventable source of medication error that, in many instances, can be identified and
`remedied prior to approval to avoid patient harm.
`
`Additionally, post-marketing experience has demonstrated that medication errors resulting from drug
`name confusion are notoriously difficult to remedy post-approval. Educational efforts and so on are low-
`leverage strategies that have proven to have limited effectiveness at alleviating the medication errors
`involving drug name confusion. Higher-leverage strategies, such as drug name changes, have been
`undertaken in the past; but at great financial cost to the Sponsor, and at the expense ofthe public welfare,
`not to mention the Agency’s credibility as the authority responsible for the approving the error-prone
`proprietary name. Moreover, even after Sponsor’s have changed a product’s proprietary name in the
`post-approval phase, it is difficult to eradicate the original proprietary name from practitioner’s
`vocabulary, and as such, the Agency has continued to receive reports of drug name confusion long after a
`name change in some instances. Therefore, we believe that post-approval efforts at reducing name
`confusion errors should be reserved for those cases in which the potential for name confusion could not
`be predicted prior. to approval (e.g. new form introduced like Lamisil) (see limitations of the process in
`Section 4).
`
`If the Division of Medication Error Prevention objects to a proposed proprietary name on the basis that
`drug name confusion could lead to medication errors, the FMEA process is used to identify strategies to
`reduce the risk of medication errors. The Division of Medication Error Prevention is likely to recommend
`that the Sponsor select an alternative proprietary name and submit the alternate name to the Agency for
`the Division ofMedication Error Prevention to review. However, in rare instances FMEA may identify
`plausible strategies that could reduce the risk of medication error of the currently proposed name, and so
`we may be able to provide the Sponsor with recommendations that reduce or eliminate the potential for
`error would render the proposed name acceptable.
`‘
`
`2.2
`
`LABEL AND LABELING RISK ASSESSMENT
`
`This section describes the methods and materials used by the Division of Medication Error Prevention
`Medication Error Staff to conduct a label, labeling, and/or packaging risk assessment (see Section 3,
`Results). The primary focus of the assessments is to identify and remedy potential sources of medication
`errors prior to drug approval. The Division of Medication Error Prevention defines a medication error as
`any preventable event that may cause or lead to inappropriate medication use or patient harm while the
`medication is in the control of the health care professional, patient, or consumer. 7
`The label and labeling of a drug product are the primary means. by which practitioners and patients
`(depending on configuration) interact with the pharmaceutical product. The container label and carton
`labeling communicate critical information including proprietary and established name, strength, form,
`container quantity, expiration, and so on. The insert labeling is intended to communicate to practitioners
`all information relevant to the approved uses of the drug, including the correct dosing and administration.
`Given the critical role that the label and labeling has in the safe use of drug products, it is not surprising
`that 33 percent of medication errors reported to the United States Pharmacopeia-Institute for Safe
`Medication Practices Medication Error Reporting Program may be attributed to the packaging and
`labeling of drug products, including 30 percent of fatal errors.8
`
`
`
`7 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerp.orglaboutMedErrors.html. Last accessed 10/1 1/2007.
`8 Institute ofMedicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`p275.
`
`

`

`Because the Division of Medication Error Prevention staff analyzes reported misuse of drugs, the
`Division of Medication Error Prevention staff is able to use this experience to identify potential errors
`with all medications similarly packaged, labeled or prescribed. The Division of Medication Error
`Prevention uses FMEA and the principles of human factors to identify potential sources of error with the
`proposed product labels and insert labeling, and provide recommendations that aim at reducing the risk of
`medication errors.
`
`The Division of Medication Error Prevention reviewed the following labels and labeling submitted by the
`Applicant on January 15, 2008. See Appendix B for pictures of the labels and labeling.
`
`0 Container Labels: Top, bottom, and sides
`
`0 Carton Labeling: Inside and outside
`
`0
`
`Package Insert Labeling (no image)
`
`0 Medication Guide (no image)
`
`0 Compact container (photo only)
`
`0 Business Reply Cards: Request for Information and Savings
`
`3 RESULTS
`
`3.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`3.1.1 Database and information sources
`
`The Division of Medication Error Prevention conducted a search of the intemet, several standard
`published databases and information sources (see Section 7 References) for existing drug names which
`sound-alike or look-alike to Treximet to a degree where potential confusion between drug names could
`occur and result in medication errors in the usual clinical practice settings. In total, thirty-nine names
`were identified as having some similarity to the name Treximet: Avandamet, Anzemet, Fortamet,
`Janumet, Trexonil, Trisenox, "'-'- ,Trexim, Tagamet, Cesamet, Tetramed, Timenton, Trexinest,
`Sinemet, - Feridex, Tofranil, Tiamate, Triatex, Tretin-X, Roxicet, Texacort, Frexivit H/C,
`Fexmid, Fioricet, Flexeril, Fiorinal,
`.._ , Trimetrexate, Tritec, Trest, Trexamette, Trexima***
`(a previously proposed name for this product), Trexina, Tetrex, Triacet, Trexall, Trexan, and Trexamate.
`
`Fourteen names were previously evaluated in OSE Review 2007-1571, dated August 16, 2007. The
`twenty-five names not previously reviewed are: Avandamet, Anzemet, Trexonil, ~ Trexim,
`Tetramed, Timentin, Trexinest, Sinemet, ~ '
`, Feridex, Tofranil, Tiamate, Tretin-X, Texacort,
`Frexivit H/C, Fexmid, Fiorinal, ‘ , Tritec, Trest, Trexamette, Trexina, Tetrex, and Trexamate.
`
`Nineteen of the twenty-five names were thought to look like Treximet, which include: Avandamet,
`Anzemet, Trexonil, ' ‘- Trexim, Tetramed, Timentin, Trexinest, Sinemet, ‘ Feridex,
`Tofranil, Tiamate, Tretin-X, Texacort, Frexivit H/C, Fexmid, Fiorinal, and - . Two names,
`Tritec and Trest, were thought to sound like Treximet. Four names, Trexamette, Trexina, Tetrex, and
`Trexamate, were thought to look and sound similar to Treximet.
`
`Additionally, the Division of Medication Error Prevention did not identify any USAN stems in the name
`Treximet.
`
`3.1.2 Expert panel discussion
`
`The Expert Panel reviewed the pool of names identified by the Division of Medication Error Prevention
`staff (see section 3.1.1. above), and did not note any additional names thought to have orthographic or
`phonetic similarity to Treximet and have the potential for confusion.
`
`

`

`10
`
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did not offer
`any additional comments relating to the proposed name.
`
`3.1.3 Safety Evaluator Risk Assessment ofProposed Proprietary Name
`
`Independent searches by the primary Safety Evaluator did not identify any additional names, thought to
`look similar to Treximet and represent a potential source of drug name confusion. However, the primary
`Safety Evaluator determined that one of the previously reviewed names in OSE review 2007-1571,
`Fortamet, needed to be reassessed due to look-alike similarity with Treximet. As such, a total of 26
`names were analyzed to determine if the drug names could be confused with Treximet, and if the drug
`name confusion would likely result in a medication error.
`
`All of the identified names were determined to have some orthographic and/or phonetic similarity to
`Treximet, and thus determined to present some risk for confusion. Failure modes and effects analysis was
`then applied to determine if the proposed name, Treximet, could potentially be confused with any of the
`26 names and lead to medication error.
`
`The FMEA determined that the name similarity between Treximet and the identified names was unlikely
`to result in medication errors for all 26 products. Six of the names identified: Tetrex, Timentin, Feridex,
`Fexmid, Tritec, and Trest were not considered further because they lack convincing orthographic and/or
`phonetic similarities with Treximet (see Appendix C).
`
`One name, — was a previously proposed names for this product and determined unacceptable
`by the Division of Medication Error Prevention. Three names, Frexivite H/C (Mexico), Trexamette
`(Japan), and Trexina (Argentina) are for foreign products for which product characteristic information
`could not be found (see Appendix D). One name,