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Are Generic Drugs Really Identical?

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.”
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 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 product. 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 could alter the way in which the medicine gets into the blood stream.

A few years ago we started hearing from readers of this column that the generic drug Budeprion XL 300 was affecting them quite differently from the brand name Wellbutrin XL 300. When we investigated, we learned that the generic used a different technology to control the release of the active ingredient bupropion. This resulted in the drug getting into the blood stream faster.

Here is just one of the hundreds of stories we have received about this: “Wellbutrin XL has worked wonders for me. Recently, however, my insurance provider substituted Budeprion for the Wellbutrin and my experience has been awful. Soon after starting it I began having feelings of despair, hopelessness, disorganized thinking, anxiety and depression.

“I’ve had physical problems as well: migraines of greater duration and intensity, sleep disturbances and night sweats. All of these changes coincide with my taking Budeprion. I have resumed taking Wellbutrin and I am feeling better and thinking more clearly.”

Readers have also reported problems with other generic formulations. The generic form of the heart and blood pressure pill, Toprol XL, has produced dozens of complaints: “I've taken Toprol XL for 11 years. When my insurance company dropped the name brand for generic metoprolol, the pharmacy re-filled without advising me. I noticed the change once my blood pressure went through the roof along with pounding heart rate, flushing and very swollen ankles. I was weak and dizzy. I demanded the pharmacy give me the correct prescription; after two months I was back to normal.”

You can read more stories at www.peoplespharmacy.com. Anyone who has a problem with a generic drug can report it to us or directly to the FDA at www.fda.gov/medwatch.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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