Safety and efficacy of generic drugs with respect to brand formulation

Journal of Pharmacology and Pharmacotherapeutics

Volumn 4, Issue SUPPL.1, 2013, Pages

  Gallelli, Luca ^a,b   Palleria, Caterina ^a,b   De Vuono, Antonio ^c   Mumoli, Laura ^a,b   Vasapollo, Piero ^c   Piro, Brunella ^c   Russo, Emilio ^a,b  

^a Mater Domini University Hospital   (Italy)

^b UNIVERSITY MAGNA GRAECIA OF CATANZARO   (Italy)

^c ASP of Cosenza   (Italy)

Author keywords

Antibiotics; bioequivalence; brand; clinical efficacy; generic; safety

Indexed keywords

AMOXICILLIN PLUS CLAVULANIC ACID; BETAMETHASONE SODIUM PHOSPHATE; CIPROFLOXACIN; GENERIC DRUG; LEVOFLOXACIN; PARACETAMOL;

ABDOMINAL DISCOMFORT; ABSENCE OF SIDE EFFECTS; ACUTE SINUSITIS; ADULT; AGED; ANTIBIOTIC SENSITIVITY; ARTICLE; BIOEQUIVALENCE; BRONCHITIS; CASE REPORT; COUGHING; CYSTITIS; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPNEA; DYSURIA; ESCHERICHIA COLI; EYE PAIN; EYE SWELLING; FEMALE; FEVER; HUMAN; MALE; MIDDLE AGED; MINIMUM INHIBITORY CONCENTRATION; NOSE OBSTRUCTION; PELVIC PAIN; RECURRENT INFECTION; RELAPSE; URINALYSIS; URINARY TRACT INFECTION; WHEEZING;

EID: 84889609366     PISSN: 0976500X     EISSN: None     Source Type: Journal    
DOI: 10.4103/0976-500X.120972     Document Type: Article

References (40)

1. Black Book-The Long View: US Perspectives 2003. ed. London: Sanford C. Bernstein & Co., LLC; 2003.
2. Kefalas CH, Ciociola AA. The FDA's generic-drug approval process: Similarities to and differences from brand-name drugs. Am J Gastroenterol 2011;106:1018-21.
3. 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;43:1583-97.
4. Kesselheim AS, Stedman MR, Bubrick EJ, Gagne JJ, Misono AS, Lee JL, et al. Seizure outcomes following the use of generic versus brandname antiepileptic drugs: A systematic review and meta-analysis. Drugs 2010;70:605-21.
5. Amit G, Rosen A, Wagshal AB, Bonneh DY, Liss T, Grosbard A, et al. Efficacy of substituting innovator propafenone for its generic formulation in patients with atrial fibrillation. Am J Cardiol 2004;93:1558-60.
6. Araszkiewicz AA, Szabert K, Godman B, Wladysiuk M, Barbui C, Haycox A. Generic olanzapine: Health authority opportunity or nightmare? Expert Rev Pharmacoecon Outcomes Res 2008;8:549-55.
7. Zore M, Harris A, Tobe LA, Siesky B, Januleviciene I, Behzadi J, et al. Generic medications in ophthalmology. Br J Ophthalmol 2013;97:253-7.
8. De Vuono A, Scicchitano F, Palleria C, Russo E, De Sarro G, Gallelli L. Lack of efficacy during the switch from brand to generic allopurinol. J Forensic Leg Med 2013;20:540-2.
9. De Vuono A, Palleria C, De Sarro G, Gallelli L. Skin rash during the treatment with generic itraconazole: Description of a case. J Pharmacol Pharmacother 2013 [In Press].
10. Ringe JD, Möller G. Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis. Rheumatol Int 2009;30:213-21.
11. Kanis JA, Reginster JY, Kaufman JM, Ringe JD, Adachi JD, Hiligsmann M, et al. A reappraisal of generic bisphosphonates in osteoporosis. Osteoporos Int 2012;23:213-21.
12. Diez-Perez A, Adachi JD, Agnusdei D, Bilezikian JP, Compston JE, Cummings SR, et al. Treatment failure in osteoporosis. Osteoporos Int 2012;23:2769-74.
13. Jain KK. Investigation and management of loss of efficacy of an antiepileptic medication using carbamazepine as an example. J R Soc Med 1993;86:133-6.
14. Privitera MD. Generic antiepileptic drugs: Current controversies and future directions. Epilepsy Curr 2008;8:113-7.
15. Rumel D, Nishioka Sde A, Santos AA. Drug interchangeability: Clinical approach and consumer's point of view. Rev Saude Publica 2006;40:921-7.
16. Gallelli L, Ferreri G, Colosimo M, Pirritano D, Guadagnino L, Pelaia G, et al. Adverse drug reactions to antibiotics observed in two pulmonology divisions of catanzaro, Italy: A six-year retrospective study. Pharmacol Res 2002;46:395-400.
17. Gallelli L, Guadagnino V, Caroleo B, Marigliano N, De Sarro GB, Izzi A. Bilateral skin ulceration after injection of pegylated interferon-alpha-2b in a patient with chronic hepatitis C. Clin Drug Investig 2003;23:615-9.
18. Gallelli L, Del Negro S, Naty S, Colosimo M, Maselli R, De Sarro G. Levofloxacin-induced taste perversion, blurred vision and dyspnoea in a young woman. Clin Drug Investig 2004;24:487-9.
19. Gallelli L, De Fazio S, Corace E, De Sarro G, Segura C, De Fazio P. A possible drug-food interaction induced generalised urticaria in a young woman. Pharmacopsychiatry 2006;39:154-6.
20. Gareri P, De Fazio P, Gallelli L, De Fazio S, Davoli A, Seminara G, et al. Venlafaxine-propafenone interaction resulting in hallucinations and psychomotor agitation. Ann Pharmacother 2008;42:434-8.
21. Gallelli L, Staltari O, Palleria C, De Sarro G, Ferraro M. Hepatotoxicity induced by methimazole in a previously healthy patient. Curr Drug Saf 2009;4:204-6.
22. Gallelli L, Spagnuolo V, Palleria C, De Sarro G, Ferraro M. A case of neuroleptic malignant syndrome induced by risperidone in a schizophrenic woman. Curr Drug Saf 2009;4:119-20.
23. Gallelli L, Colosimo M, Tolotta GA, Falcone D, Luberto L, Curto LS, et al. Prospective randomized double-blind trial of racecadotril compared with loperamide in elderly people with gastroenteritis living in nursing homes. Eur J Clin Pharmacol 2010;66:137-44.
24. Siniscalchi A, Gallelli L, Calabrò G, Tolotta GA, De Sarro G. Phenobarbital/lamotrigine coadministration-induced blood dyscrasia in a patient with epilepsy. Ann Pharmacother 2010;44:2031-4.
25. Gallelli L, Staltari O, Palleria C, Di Mizio G, De Sarro G, Caroleo B. A case of adverse drug reaction induced by dispensing error. J Forensic Leg Med 2012;19:497-8.
26. Scicchitano F, Giofrè C, Palleria C, Mazzitello C, Ciriaco M, Gallelli L, et al. Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis. J Res Med Sci 2012;17:872-5.
27. Luzzaro F. Fluoroquinolones and Gram-negative bacteria: Antimicrobial activity and mechanisms of resistance. Infez Med 2008;16 Suppl 2:5-11.
28. Patanè M, Ciriaco M, Chimirri S, Ursini F, Naty S, Grembiale RD, et al. Interactions among low dose of methotrexate and drugs used in the treatment of rheumatoid arthritis. Adv Pharmacol Sci 2013;2013:313-858.
29. Giofrè C, Scicchitano F, Palleria C, Mazzitello C, Ciriaco M, Gallelli L et al. Pharmacovigilance and drug safety 2012 in Calabria (Italy): Adverse events analysis. J Pharmacol Pharmacother 2013 [In Press].
30. Mouton JW, Dudley MN, Cars O, Derendorf H, Drusano GL. Standardization of pharmacokinetic/pharmacodynamic (PK/PD) terminology for anti-infective drugs: An update. J Antimicrob Chemother 2005;55:601-7.
31. De Fazio S, Gallelli L, De Siena A, De Sarro G, Scordo MG. Role of CYP3A5 in abnormal clearance of methadone. Ann Pharmacother 2008;42:893-7.
32. Gallelli L, Ferraro M, Spagnuolo V, Rende P, Mauro GF, De Sarro G. Rosuvastatin-induced rhabdomyolysis probably via CYP2C9 saturation. Drug Metabol Drug Interact 2009;24:83-7.
33. Versantvoort C, Maliepaard M, Lekkerkerker F. Generics: What is the role of registration authorities. Neth J Med 2008;66:62-6.
34. Guideline on the Investigation of Bioequivalence. European Medicines Agency, 2010. Available from: http://www.ema.europa.eu/pdfs/human/qwp/ 140198enrev1fin.pdf. [Accessed on 2012 Sep 4].
35. Blencowe NS, Reichl C, Gahir J, Paterson I. The use of nolvadex in the treatment of generic tamoxifen-associated small joint arthralgia. Breast 2010;19:243-5.
36. Mumoli N, Cei M, Luschi R, Carmignani G, Camaiti A. Allergic reaction to croscarmellose sodium used as excipient of a generic drug. QJM 2011;104:709-10.
37. Reiffel JA. Formulation substitution and other pharmacokinetic variability: Underappreciated variables affecting antiarrhythmic efficacy and safety in clinical practice. Am J Cardiol 2000;85:46D-52.
38. Tange M, Yoshida M, Nakai Y, Uchida T. Comparison between original and generic versions of ceftriaxone sodium preparation for injection: Compatibility with calcium-containing product. Chem Pharm Bull (Tokyo) 2012;60:429-34.
39. Gauzit R, Lakdhari M. Generic antibiotic drugs: Is effectiveness guaranteed? Med Mal Infect 2012;42:141-8.
40. Manning R, Smith R. Brand-name versus generic drugs. Health Aff (Millwood) 2011;30:2027-8.