| Treatment failure after substitution of generic pancrelipase capsules. Correlation with in vitro lipase activity. | |
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MedLine Citation:
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PMID: 2329633 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Pancreatic enzyme products are formulated, manufactured, and sold without submitting efficacy or bioavailability data to the Food and Drug Administration because of a quirk in the law. We documented therapeutic failures in three patients with cystic fibrosis after pharmacists substituted generic pancrelipase capsules for the Pancrease brand. Gastrointestinal symptoms and fat malabsorption rapidly resolved after therapy was reinstituted with brand name products. In vitro analysis indicated that after 1 hour of exposure to simulated gastric fluid, lipase activity was less than 200 U per capsule from all three generic capsules dispensed to the patients compared with 6820 U per capsule from Pancrease. These data indicate that the enteric coating of the generic product was defective and that the substituted product was not bioequivalent to the prescribed brand. We conclude that the Food and Drug Administration should institute regulations over this group of products. |
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Authors:
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L Hendeles; A Dorf; A Stecenko; M Weinberger |
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Publication Detail:
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Type: Case Reports; Journal Article |
Journal Detail:
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Title: JAMA : the journal of the American Medical Association Volume: 263 ISSN: 0098-7484 ISO Abbreviation: JAMA Publication Date: 1990 May |
Date Detail:
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Created Date: 1990-05-25 Completed Date: 1990-05-25 Revised Date: 2006-11-07 |
Medline Journal Info:
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Nlm Unique ID: 7501160 Medline TA: JAMA Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 2459-61 Citation Subset: AIM; IM |
Affiliation:
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College of Pharmacy, University of Florida, Gainesville 32610-0486. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Capsules Child Cystic Fibrosis / drug therapy* Female Humans Infant Lipase / adverse effects*, metabolism* Male Pancreatic Extracts / adverse effects*, metabolism Pancrelipase Reference Standards Therapeutic Equivalency* |
| Chemical | |
Reg. No./Substance:
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0/Capsules; 0/Pancreatic Extracts; 53608-75-6/Pancrelipase; EC 3.1.1.3/Lipase |
| Comments/Corrections | |
Comment In:
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JAMA. 1990 May 9;263(18):2491-2
[PMID:
2329638
]
JAMA. 1990 Dec 26;264(24):3148-9 [PMID: 2255022 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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