So what is the controversy with switching from brand name to generic name drugs? Even though the FDA requires generic and brand name drugs to have the same active ingredients and therapeutic effect, many still believe that some generic drugs do not work as good as brand name drugs. Many consumers expressed concerns that when switching from their brand name drug to generic, the generic counterpart was not as effective. So why might a generic drug work differently than brand name drugs? All ingredients, including inactive ingredients, that are used in a particular product formulation affects how the drug is absorbed in the bloodstream. If the inactive ingredients in generic drugs are different from the brand name counterpart do you think this might be a cause for experiencing slightly different effects on the body when switching between the two? The answer is yes, but it should not be a huge difference.The FDA has said that some variability does occur, but the FDA puts a limit on how much of a variability can occur. Inactive ingredients such as coating, stabilizers, fillers, binders, flavorings, diluents, and others are necessary to turn a chemical into a usable drug product. They can give a drug its color, size, and even taste. Inactive ingredients are usually harmless substances that do not affect the body. However a small number of people may react to these inactive ingredients. Because inactive ingredients can cause unusual and sometimes severe allergic reactions in a few people, one version, or brand, of a drug may be preferable to another. Having allergic reactions when switching from a particular brand name drug to generic DOES NOT necessarily mean the drug itself is less effective. Your body is unique in its own ways, so it is expected that not everyone will react the same to a certain drug. Since the human body is always changing, factors such as diet, metabolic rate, and hormones can also affect how a drug acts in the body. Drugs with narrow therapeutic ranges can also be a cause of concern because there is a thin line between therapeutic range and toxic range. The more narrow the therapeutic index is, the higher the risk for toxicity. It is these small differences that could effect how medication works in your body. Certain drug classes have become of particular interest when it comes to effectiveness of drugs when switched from brand name to generic. These drug classes include: antidepressants, antihypertensive drugs, and antiepileptic drugs, to name a few. The next several posts explore studies and research that address controversy within these drug classes.
Source:
FDA U.S. food and drug administration, October 13, 2009
Harold M. Silverman, April 2007
http://www.merck.com/mmhe/sec02/ch017/ch017b.html
Original Drugs, November 24th, 2008
http://www.originaldrugs.com/blog/general/brand-vs-generic-drugs/
