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Johns Hopkins Health Alert

Using Generic Drugs Safely

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Health insurance companies love generic drugs, because they cost less money than branded versions – but are generic drugs right for you?

Are generic drugs safe? The short answer is yes, because in the United States, manufacturers must prove to the FDA that the generic version of a drug has the same active ingredient as the original, branded version and that it is absorbed into the body approximately as well (with no more than a 20 percent difference in absorption).

In short, a generic drug should be interchangeable with the brand-name version, if used in the same way for the same medical conditions. According to an FDA website, studies show no difference in the rate of side effects between generic drugs and brand-name drugs.

Health insurers love generic drugs, because they cost less money than branded versions -- on average, 30 percent less. But there are some instances when your doctor may not think it’s a good idea to switch to a generic drug. This is often the case for medications that have a narrow therapeutic range (NTR).

When you take an NTR drug, the most effective dose with the fewest side effects lies in a narrow range between too little and too much. These are medications in which small changes in the dose and/or blood concentration could result in clinically important changes in drug efficacy or safety. Usually, these drugs require frequent adjustments in the dosage and the user needs to be monitored carefully, regardless of whether the drug is a brand-name or generic drug product.

One such drug in common use is Coumadin. If you have taken brand-name warfarin for a long time, your doctor may not want to switch you to a generic because slight differences in the generic version could alter the concentration of the drug in your blood. This could thin your blood too much, causing bleeding or too little, raising the risk that a clot could form. Other common NTR medications include digoxin (a cardiac treatment) and certain drugs used to control epileptic seizures.

Posted in Prescription Drugs on August 21, 2007
Reviewed June 2011


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