This Article  • References  • Full text PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (36)  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Social Bookmarking   What's this?

Correlation With In Vitro Lipase Activity

Leslie Hendeles, PharmD; Adrienne Dorf, MPH, RD; Arlene Stecenko, MD; Miles Weinberger, MD

JAMA. 1990;263(18):2459-2461.

Abstract
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.

(JAMA. 1990;263:2459-2461)

Author Affiliations
From the College of Pharmacy (Dr Hendeles) and the Division of Pediatric Pulmonary Disease/Cystic Fibrosis (Drs Hendeles and Stecenko and Ms Dorf), University of Florida, Gainesville; and the Pediatric Allergy/Pulmonary Division, University of Iowa, Iowa City (Dr Weinberger).

Footnotes
Reprint requests to University of Florida, Box J-486 JHMHC, Gainesville, FL32610-0486 (Dr Hendeles).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Generic Substitution and Optimal Patient Care
Murphy
Arch Intern Med 1999;159:429-433.
FULL TEXT  

A Physician Survey on Generic Drugs and Substitution of Critical Dose Medications
Banahan and Kolassa
Arch Intern Med 1997;157:2080-2088.
ABSTRACT  

An Asfaliogenic Complication Arising From Profit-motivated Decision-making
Irish et al.
Pediatrics 1997;99:503-504.
FULL TEXT  

Pancreatic Extract Lipase Activity
Lebenthal et al.
JAMA 1993;270:2557-2558.
ABSTRACT  

Treatment Failure After Substitution of Generic Pancrelipase Capsules
Haymes and Levy
JAMA 1990;264:3148-3149.
ABSTRACT  

FAILURE OF A GENERIC PANCREATIC ENZYME SUPPLEMENT
JWatch General 1990;1990:4-4.
FULL TEXT  

Regulatory Status of Pancreatic Enzyme Preparations
Rheinstein
JAMA 1990;263:2491-2492.
ABSTRACT