Treatment failure after substitution of generic pancrelipase capsules: correlation with in vitro lipase activity

Article Abstract:

Because pancreatic enzyme products were available before the 1938 Food, Drug and Cosmetic Act was passed, they are not subject to Food and Drug Administration (FDA) approval for efficacy or bioavailability. Pancrelipase is the enzyme that is most commonly used for pancreatic enzyme replacement therapy. A common problem associated with pancrelipase has been inactivation of the enzyme by stomach acids prior to its absorption in the intestine. Three cases are presented of patients with cystic fibrosis who were treated with generic substitutes of brand-name pancrelipase capsules. Treatment failure in these patients was indicated by malabsorption of fat and gastrointestinal symptoms. In each case, when a brand-name product was administered after discontinuation of the generic product, symptoms resolved rapidly. When the generic and the brand-name products were tested, they showed pharmaceutically different compositions and contained different amounts of lipase. They were not bioequivalent and did not react to the same concentrations of gastric acid. Based on these results, four recommendations are made. Physicians should clearly indicate that no substitutions are to be allowed when prescribing pancrelipase. Pharmacists should not make any substitutions before checking with the prescribing physician. Regulations for pancreatic enzyme products should be developed by the FDA, and bioequivalency should be required for all products. Finally, standards for testing the potency of these pancreatic supplements need to be developed by the US Pharmacopeia. (Consumer Summary produced by Reliance Medical Information, Inc.)

Physiological aspects, Drug therapy, Cystic fibrosis, Generic drugs, Enteric-coated tablets, Enteric coated tablets, Digestive enzymes

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Acute renal failure - a dangerous condition

Article Abstract:

Acute kidney failure can be a serious disease independent of any underlying conditions. A 1996 study found that patients with underlying medical conditions who developed kidney failure had a higher mortality rate than patients with the same medical conditions who did not develop kidney failure. They were also more likely to develop serious conditions such as respiratory failure, coma and serious bacterial infections. Acute kidney failure is often caused by medical procedures and can easily be prevented. Putting patients on dialysis may not necessarily be the most effective treatment, since mortality rates in these patients are as high as 10%. Patients at high risk of acute kidney failure are those with heart disease who undergo diagnostic procedures that involve contrast dyes. Their risk can be reduced by keeping them hydrated and using low-osmolar contrast dyes. Any increase in creatinine levels in postoperative patients should be managed aggressively.

Care and treatment, Editorial, Acute renal failure, Acute kidney failure

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Update on FDA Regulation of In Vitro Diagnostic Devices

Article Abstract:

Scientists in the FDA's Office of Device Evaluation describe the process by which the agency regulates diagnostic reagents and tests. A staff of 45 scientists reviews about 1,000 premarket applications from device manufacturers annually. In 1993, the MedWatch system was introduced, which allows physicians to report problems with diagnostic tests. FDA staff can also learn of such problems by reviewing the medical literature. The agency can recall devices but prefers to work with manufacturers to resolve the problem.

Laws, regulations and rules, United States. Food and Drug Administration, Medical testing products, Diagnostic reagents and test kits, Diagnostic reagents

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