2.20.2009

ARE GENERICS AND BRAND NAMES IDENTICAL?

Este artigo, do site ThirdAge.com, além de interessante, contém um bom vocabulário na área farmacêutica.

"In answering the question "What are Generic Drugs?" on its Web site, the Food and Drug Administration states unequivocally: "A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use." But just how true is that?

If you check the Oxford Dictionary, you will find this definition for the word "identical": adj. 1. agreeing in every detail. 2. one and the same. The Merriam-Webster online dictionary defines "identical" as 1: being the same 2: having such close resemblance as to be essentially the same.

Given such definitions, it's only logical that patients, physicians and pharmacists would assume that all generic drugs are exactly the same as their brand-name counterparts. The reality, however, is not so clear. For one thing, the FDA does not require generic drugs to contain the same inactive ingredients as the brand-name products. That means colors, binders and fillers (that often make up the majority of the pills) can be quite different. In some cases, this may mean someone is allergic to one formulation of a generic drug even though he tolerates the brand name. Many pills are designed to release the active ingredient over a sustained period of time. Generic products may use a different formulation. This may alter the way in which the medicine gets into the bloodstream. "