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Are generics as effective as brand-name drugs? Substituting generics for their pricier equivalents is usually safe, but some cases warrant more caution.

You may find that many generic products, although cheaper, just can't match the quality of their brand-name counterparts.

But when it comes to your prescription medications, you need to know that the generics you take are doing more than saving you money. They have to be as safe and effective as the brand-name, or innovator, versions they're patterned after.

"I encourage the use of generics," says Mandy Leonard, R.Ph., Pharm. D., BCPS, manager of Cleveland Clinic's Drug Information Service. "I know some people don't think generics work as well as the brands, but the generics on the market have been tested to meet certain therapeutic bioequivalence standards."

In the overwhelming majority of cases, you can switch from an innovator drug to its generic equivalent with no problem, but with some medications, you might have to stick with the brand names or require more careful monitoring if you switch, Dr. Leonard advises.


New drugs are covered by patent protection, granting their makers the sole right to sell the medication while the patent is in effect. Once the patent expires, manufacturers can receive approval from the U.S. Food and Drug Administration (FDA) to sell generic versions of the drug. According to the FDA, generic versions, on average, cost 80-85 percent less than the innovator drug.

The FDA approves all brand-name and generic drugs, and the standards of quality are the same for either type. The generic drug must have the same active ingredients, strength, dosage form and essentially the same labeling as that of the original approved medication. Manufacturers also must demonstrate bioequivalence--essentially, the time it takes the generic drug to reach the bloodstream and the amount of the drug in the bloodstream at any given time must be similar to that of the innovator drug.


But generics are not identical to their brand-name kin. They may contain different inactive ingredients, such as those used for coloring, coating or binding the pills. They also may not be exactly bioequivalent. An FDA review of 12 years worth of bioequivalence date found that the average difference in the rate and extent of drug absorption between generics and brand-name drugs was 4.35 and 3.56 percent, respectively, while less than two percent of drugs varied by more than 10 percent. The FDA notes that these differences are not great enough to reduce the therapeutic benefits of the drugs or be harmful.

The findings, published in the October 2009 issue of The Annals of Pharmacotherapy, support the FDA's stance that "health professionals can substitute drug products determined to be therapeutically equivalent with the full expectation that the generic product will produce the same clinical effect and safety profile as the innovator product," the author wrote.


While making the switch from brand-name to generic is safe for most drugs, for some it can be risky, as any variability between the medications may present problems. For instance, narrow-therapeutic-index drugs, such as the anticoagulant warfarin (Coumadin), must be dosed precisely or patients risk excessive bleeding or, conversely, blood clots that cause heart attacks and strokes.

Dr. Leonard says switching from brand names to generic versions of other drugs--such as synthetic thyroid (levothyroxine), immunosuppressants (cyclosporine) and anti-epileptic/anti-seizure medications--also may produce unwanted effects and should be done with caution, if at all. "The majority of people can be switched safely from brand to a generic, but it's those certain drugs that I would encourage patients to have a discussion with their physician about," she adds. "They may need some additional monitoring to make sure everything is all right."

She also cautions about subtle differences between generic drugs, and she urges patients to be cognizant of each pill they take, visit the same pharmacy, and establish a relationship with the pharmacist there.

"If the tablet size, shape or color changes, you should ask the pharmacist if it's the right medicine or if they just got a new generic in," she says. "For the majority of people, nothing happens, but you have to be careful. If you have any additional concerns or questions, you should always have them addressed by your physician or your pharmacist."


* Is there a generic version of the drug I'm taking?

* Is it safe to switch to a generic version of my medication?

* Will I require any follow-up blood tests or other monitoring if I switch?

* Am I likely to experience different side effects with the generic drug?

* What should I do if I experience side effects?

* How much money can I save by switching to a generic medication?
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Title Annotation:MEDICINE CHEST
Publication:Men's Health Advisor
Date:Sep 1, 2010
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