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01-04-2018 | Commentary

The Safety of Generic Prescription Drugs in the United States

Author: Sonal Singh

Published in: Drug Safety | Issue 4/2018

Excerpt

‘Then you should say what you mean,’ the March Hare went on.

‘I do,’ Alice hastily replied; ‘at least—at least I mean what I say—that’s the same thing, you know.’

‘Not the same thing a bit!’ said the Hatter. ‘You might just as well say that “I see what I eat” is the same thing as “I eat what I see”!’

‘You might just as well say,’ added the March Hare, ‘that “I like what I get” is the same thing as “I get what I like”!’

‘You might just as well say,’ added the Dormouse, who seemed to be talking in his sleep, ‘that “I breathe when I sleep” is the same thing as “I sleep when I breathe”!’

Alice in Wonderland, Chapter VII—“The Mad Tea Party”;

Lewis Carroll 1865 [1]

…

Caroll L. Alice in Wonderland. Project Gutenberg’s Alice’s Adventures in Wonderland, by Lewis Carroll [Internet]. 1865. http://www.gutenberg.org/files/11/11-h/11-h.htm. Accessed 11 Dec 2017.

Association GP. Generic drugs savings in the US 2015 Seventh Annual Edition: http://www.gphaonline.org/media/wysiwyg/PDF/GPhA_Savings_Report_2015.pdf. Accessed 11 Dec 2017.

Dunne SS, Dunne CP. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC Med. 2015;13:173.CrossRefPubMedPubMedCentral

Katie T. Generic A.D.H.D drug, not equivalent to the brand, is in use anway. New York Times. 2015. https://www.nytimes.com/2015/06/17/business/generic-ritalin-drug-not-equivalent-to-the-brand-is-in-use-anyway.html. Accessed 11 Dec 2017.

Park-Wyllie L, van Stralen J, Castillon G, Sherman SE, Almagor D. Differences in adverse event reporting rates of therapeutic failure between two once-daily extended-release methylphenidate medications in Canada: analysis of spontaneous adverse event reporting databases. Clin Ther. 2017;39(10):2006–23.CrossRefPubMed

American Enterprise Institute. Dangerous drugs in your medicine cabinet? A whistleblower’s account of India’s troubling exports. 2013. http://www.aei.org/wp-content/uploads/2013/12/-dangerous-drugs-transcript_091805504114.pdf. Accessed 11 Dec 2017.

Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583–97.CrossRefPubMed

Endrenyi L, Tothfalusi L. Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drug products? J Pharm Pharmaceut Sci Publ Can Soc Pharmaceut Sci Soc Can Des Sci Pharmaceut. 2010;13(1):107–13.

Moore TJ, Singh S, Furberg CD. The FDA and new safety warnings. Arch Internal Med. 2012;172(1):78–80.CrossRef

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Iyer G, Marimuthu SP, Segal JB, Singh S. An algorithm to identify generic drugs in the FDA Adverse Event Reporting System. Drug Saf. 2017;40(9):799–808.CrossRefPubMed

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Bohn J, Kortepeter C, Munoz M, Simms K, Montenegro S, Dal Pan G. Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs. Clin Pharmacol Ther. 2015;97(5):508–17.CrossRefPubMed

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Institute of Safe Medicine Practices. A critique of a key drug safety reporting system. 2015. Updated January 28, 2015. https://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=100. Accessed 11 Dec 2017

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Cheng N, Rahman MM, Alatawi Y, Qian J, Peissig PL, Berg RL, et al. Mixed approach retrospective analyses of suicide and suicidal ideation for brand compared with generic central nervous system drugs. Drug Saf. 2017. https://doi.org/10.1007/s40264-017-0624-0 (Epub ahead of print).PubMed

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Moore TJ, Furberg CD, Glenmullen J, Maltsberger JT, Singh S. Suicidal behavior and depression in smoking cessation treatments. PLoS One. 2011;6(11):e27016.CrossRefPubMedPubMedCentral

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FDA. FDA Adverse Events Reporting System (FAERS) Public Dashboard: FDA; 2017. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm. Accessed 11 Dec 2017

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Marimuthu SP, Iyer G, Segal JB, Singh S. Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study. J Comp Effect Res. 2017;6(5):437–47.CrossRef

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Zorzela L, Loke YK, Ioannidis JP, Golder S, Santaguida P, Altman DG, et al. PRISMA harms checklist: improving harms reporting in systematic reviews. BMJ. 2016;352:i157.CrossRefPubMed

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Onasaya OIG, Lucas E, Lin D, Singh S, Alexander GC. Association between exogenous testosterone and cardiovascular events: an overview of systematic reviews. Lancet Diab Endocrinol. 2016;4(11):943–56.CrossRef

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Alexander GCIG, Lucas E, Lin D, Singh S. Cardiovascular risks of exogenous testosterone use among men: a systematic review and meta-analysis. Am J Med. 2017;130(3):293–305.CrossRefPubMed

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Abraham NS, Singh S, Alexander GC, Heien H, Haas LR, Crown W, et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study. BMJ. 2015;350:h1857.CrossRefPubMedPubMedCentral

22.

Chang H-Y, Zhou M, Tang W, Alexander GC, Singh S. Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study. BMJ. 2015;350:h1585.CrossRefPubMedPubMedCentral

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Tang W, Chang H-Y, Zhou M, Singh S. Risk of major gastrointestinal bleeding among dabigatran users: a population-based, new-user, self-controlled study. J Patient-Cent Re Rev. 2017;4(3):181.

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Maruthur NM, Joy SM, Dolan JG, Shihab HM, Singh S. Use of the analytic hierarchy process for medication decision-making in type 2 diabetes. PLoS One. 2015;10(5):e0126625.CrossRefPubMedPubMedCentral

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Westerhoff J. Nāgārjuna’s Madhyamaka. A philosophical introduction. Oxford: Oxford University Press; 2009.CrossRef

Title: The Safety of Generic Prescription Drugs in the United States
Author: Sonal Singh
Publication date: 01-04-2018
Publisher: Springer International Publishing
Published in: Drug Safety / Issue 4/2018
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI: https://doi.org/10.1007/s40264-017-0632-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The Safety of Generic Prescription Drugs in the United States

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Keynote webinar | Spotlight on medication adherence

Springer Medicine

Excerpt

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