The human experience with intravenous levodopa
Objective: To compile a comprehensive summary of published human experience with levodopa given intravenously, with a focus on information required by regulatory agencies.Background: While safe intravenous (IV) use of levodopa has been documented for over 50 years, regulatory supervision for pharmac...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2016-01-01
|
| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | http://journal.frontiersin.org/Journal/10.3389/fphar.2015.00307/full |
| _version_ | 1818825619029360640 |
|---|---|
| author | Shan H Siddiqi Natalia K Abraham Christopher L Geiger Morvarid eKarimi Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Kevin J Black Kevin J Black Kevin J Black Kevin J Black Kevin J Black |
| author_facet | Shan H Siddiqi Natalia K Abraham Christopher L Geiger Morvarid eKarimi Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Kevin J Black Kevin J Black Kevin J Black Kevin J Black Kevin J Black |
| author_sort | Shan H Siddiqi |
| collection | DOAJ |
| description | Objective: To compile a comprehensive summary of published human experience with levodopa given intravenously, with a focus on information required by regulatory agencies.Background: While safe intravenous (IV) use of levodopa has been documented for over 50 years, regulatory supervision for pharmaceuticals given by a route other than that approved by the U.S. Food and Drug Administration (FDA) has become increasingly cautious. If delivering a drug by an alternate route raises the risk of adverse events, an investigational new drug (IND) application is required, including a comprehensive review of toxicity data.Methods: Over 200 articles referring to IV levodopa were examined for details of administration, pharmacokinetics, benefit and side effects.Results: We identified 142 original reports describing IVLD use in humans, beginning with psychiatric research in 1959-1960 before the development of peripheral decarboxylase inhibitors. Over 2750 subjects have received IV levodopa, and reported outcomes include parkinsonian signs, sleep variables, hormone levels, hemodynamics, CSF amino acid composition, regional cerebral blood flow, cognition, perception and complex behavior. Mean pharmacokinetic variables were summarized for 49 healthy subjects and 190 with Parkinson’s disease. Side effects were those expected from clinical experience with oral levodopa and dopamine agonists. No articles reported deaths or induction of psychosis.Conclusion: Over 2750 patients have received IV levodopa with a safety profile comparable to that seen with oral administration. |
| first_indexed | 2024-12-19T00:14:38Z |
| format | Article |
| id | doaj.art-27693fd3fed0496480edff703c0e1239 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-19T00:14:38Z |
| publishDate | 2016-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-27693fd3fed0496480edff703c0e12392022-12-21T20:45:53ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122016-01-01610.3389/fphar.2015.00307168565The human experience with intravenous levodopaShan H Siddiqi0Natalia K Abraham1Christopher L Geiger2Morvarid eKarimi3Joel S Perlmutter4Joel S Perlmutter5Joel S Perlmutter6Joel S Perlmutter7Joel S Perlmutter8Kevin J Black9Kevin J Black10Kevin J Black11Kevin J Black12Kevin J Black13Washington University School of MedicineUniversity of OttawaUniversity of Washington, SeattleWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineWashington University School of MedicineObjective: To compile a comprehensive summary of published human experience with levodopa given intravenously, with a focus on information required by regulatory agencies.Background: While safe intravenous (IV) use of levodopa has been documented for over 50 years, regulatory supervision for pharmaceuticals given by a route other than that approved by the U.S. Food and Drug Administration (FDA) has become increasingly cautious. If delivering a drug by an alternate route raises the risk of adverse events, an investigational new drug (IND) application is required, including a comprehensive review of toxicity data.Methods: Over 200 articles referring to IV levodopa were examined for details of administration, pharmacokinetics, benefit and side effects.Results: We identified 142 original reports describing IVLD use in humans, beginning with psychiatric research in 1959-1960 before the development of peripheral decarboxylase inhibitors. Over 2750 subjects have received IV levodopa, and reported outcomes include parkinsonian signs, sleep variables, hormone levels, hemodynamics, CSF amino acid composition, regional cerebral blood flow, cognition, perception and complex behavior. Mean pharmacokinetic variables were summarized for 49 healthy subjects and 190 with Parkinson’s disease. Side effects were those expected from clinical experience with oral levodopa and dopamine agonists. No articles reported deaths or induction of psychosis.Conclusion: Over 2750 patients have received IV levodopa with a safety profile comparable to that seen with oral administration.http://journal.frontiersin.org/Journal/10.3389/fphar.2015.00307/fullCarbidopaLevodopaParkinsonpharmacokineticsintravenousfda |
| spellingShingle | Shan H Siddiqi Natalia K Abraham Christopher L Geiger Morvarid eKarimi Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Joel S Perlmutter Kevin J Black Kevin J Black Kevin J Black Kevin J Black Kevin J Black The human experience with intravenous levodopa Frontiers in Pharmacology Carbidopa Levodopa Parkinson pharmacokinetics intravenous fda |
| title | The human experience with intravenous levodopa |
| title_full | The human experience with intravenous levodopa |
| title_fullStr | The human experience with intravenous levodopa |
| title_full_unstemmed | The human experience with intravenous levodopa |
| title_short | The human experience with intravenous levodopa |
| title_sort | human experience with intravenous levodopa |
| topic | Carbidopa Levodopa Parkinson pharmacokinetics intravenous fda |
| url | http://journal.frontiersin.org/Journal/10.3389/fphar.2015.00307/full |
| work_keys_str_mv | AT shanhsiddiqi thehumanexperiencewithintravenouslevodopa AT nataliakabraham thehumanexperiencewithintravenouslevodopa AT christopherlgeiger thehumanexperiencewithintravenouslevodopa AT morvaridekarimi thehumanexperiencewithintravenouslevodopa AT joelsperlmutter thehumanexperiencewithintravenouslevodopa AT joelsperlmutter thehumanexperiencewithintravenouslevodopa AT joelsperlmutter thehumanexperiencewithintravenouslevodopa AT joelsperlmutter thehumanexperiencewithintravenouslevodopa AT joelsperlmutter thehumanexperiencewithintravenouslevodopa AT kevinjblack thehumanexperiencewithintravenouslevodopa AT kevinjblack thehumanexperiencewithintravenouslevodopa AT kevinjblack thehumanexperiencewithintravenouslevodopa AT kevinjblack thehumanexperiencewithintravenouslevodopa AT kevinjblack thehumanexperiencewithintravenouslevodopa AT shanhsiddiqi humanexperiencewithintravenouslevodopa AT nataliakabraham humanexperiencewithintravenouslevodopa AT christopherlgeiger humanexperiencewithintravenouslevodopa AT morvaridekarimi humanexperiencewithintravenouslevodopa AT joelsperlmutter humanexperiencewithintravenouslevodopa AT joelsperlmutter humanexperiencewithintravenouslevodopa AT joelsperlmutter humanexperiencewithintravenouslevodopa AT joelsperlmutter humanexperiencewithintravenouslevodopa AT joelsperlmutter humanexperiencewithintravenouslevodopa AT kevinjblack humanexperiencewithintravenouslevodopa AT kevinjblack humanexperiencewithintravenouslevodopa AT kevinjblack humanexperiencewithintravenouslevodopa AT kevinjblack humanexperiencewithintravenouslevodopa AT kevinjblack humanexperiencewithintravenouslevodopa |