How Safe Is That Generic?

Seventy percent of Americans take prescription drugs, and 75 percent of those drugs are generics. And it’s no wonder: generic drugs contain the same active ingredients as brand name drugs, and can cost up to 95 percent less . Generic drugs save billions of dollars a year in healthcare costs, and the FDA requires that they “ have the same high quality, strength, purity and stability as brand-name drugs .” But some doctors and researchers questioned whether certain generic drugs—including the antidepressant Wellbutrin XL 300, the heart medicine Toprol XL , and the anti seizure medicine Keppra —work as well as their brand-name counterparts.

New drugs are protected by patent laws, and cannot be copied. But once a drug’s patent expires, other manufacturers can create their own generic version of the drug using the same active ingredient. Because the original drug is already in use, generic manufacturers do not have to invest money in development, testing, and advertising, and can sell their drugs at lower costs.

Like new drugs, generic drugs are regulated and approved by the FDA. Manufacturers must prove that their generic version is bioequivalent to the original brand name version—in other words, they must prove that the same amount of the drug’s active ingredient reaches the bloodstream. But the FDA’s acceptable range for bioequivalence is between 80 and 125 percent of the original drug, which means that generics can be slightly stronger or weaker than their brand name counterparts.

What do consumers need to know?

For certain drugs, small changes in dose can make a big difference. Some researchers worry that the FDA’s bioequivalence range may be too wide, especially for patients who are taking medication to control problems like  arrhythmias  or  seizures . When switching from brand name to generic drugs, or from one generic to another, consumers should report any unexpected changes or side effects to their doctors.

Generics contain the same active ingredient as brand name drugs, but they often use different fillers and binding agents. These “inactive ingredients” do not affect how well the drug works, but people may have allergies to a particular ingredient, and cannot take certain generics.

When more than one generic is available, pharmacies may switch to a different generic based on cost or availability. If the shape or color of a pill changes when you refill your prescription, the pharmacy is likely stocking a new generic, which may be slightly different from the one you’re used to.

Consumers should be aware that slight differences between brand name and generic drugs exist, but research shows that generic drugs are safe and effective.

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