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Are generic drugs safe?

Despite widespread use, our survey shows concerns persist

Published: August 2012

About three-quarters of prescription medication American adults take are generics, but 43 percent of us have a concern or misperception about them, according to a 2012 poll by the Consumer Reports National Research Center.

“When people hear the word ‘generic,’ they think of generic plastic wrap or generic pasta, and associate that with inferior quality,” says Aaron S. Kesselheim, M.D., an assistant professor of medicine at Brigham and Women’s Hospital in Boston. “But for the vast majority of people, generic drugs are as safe and effective as brand-name drugs.”

Indeed, the drugs—copies of brand-name medication whose patents have expired—contain the identical active ingredients in the same quantity. And because brand-name drugs are prescribed for many years before they can be copied, their generic clones are considered, by extension, “tried and true.” Overall, generic drugs appear no more likely than brand-name drugs to pose risks.

But generic and branded drugs do differ in one important area: price. Generics can cost up to 95 percent less because manufacturers don’t have the expense of developing them from scratch and rarely spend money on advertising. The lower price not only helps your wallet but might also help your health. Research suggests that people who use generics are more likely to stay on the drugs as directed, compared with those who use costlier brand-name drugs. Below we examine the concerns about generic drugs and help you weigh the evidence.   

FDA standards for approving generic drugs

The Food and Drug Administration requires that over-the-counter and prescription generic drugs have exactly the same active ingredients in the same strength as the brands they copy. It also requires that they have the same purity and stability, come in the same form—for example, tablet, patch, or liquid—and be administered the same way (for example, swallowed as a pill or given as an injection). In addition, manufacturers of a generic must demonstrate that the drug is “bioequivalent” to its corresponding brand by showing that it delivers the same amount of active ingredients into a person’s bloodstream in the same time as the original brand. A 2009 analysis of 2,070 bioequivalence studies found that the average difference in absorption—using two measures—between a generic and its branded prototype was about 4 percent, the same variation that is found between two batches of the same brand-name drug. 

Are generic drugs made overseas safe?

Yes, or at least as safe as brand-name drugs made overseas. Eighty percent of the active ingredients in all U.S. drugs—generic and branded—are now made in foreign countries. In fact, most brand-name drugs are produced in the same countries and often the same factories as their generic counterparts. There have been concerns about generic drugs made overseas, but there have been reports of problems with brand-name drugs, too. For example, in 2009 the FDA took action against a generic drugmaker for falsifying data and test results at one of its facilities in India. The previous year, an FDA investigation found that the active ingredient in branded versions of the blood thinner heparin, made in China, had been contaminated. The agency has not had have sufficient resources or access to inspect foreign facilities as often as it does domestic ones.

“That potentially affects both brand-name and generic drugs, and we need to be vigilant about it,” Kesselheim says. “But so far, it appears that counterfeit or adulterated drugs are extremely rare in the U.S.”

The FDA has recently taken steps to increase overseas inspections, and some U.S. drugmakers inspect their foreign facilities. The Food and Drug Administration Safety and Innovation Act of 2012, signed by President Obama in July, provides additional resources for inspections of manufacturing facilities overseas.

When to use caution: The NTIs

Some experts think so, though that’s controversial. Articles in medical journals and other media have debated the safety of using generics in place of brand-name drugs that have a “narrow therapeutic index” (NTI) because they are effective and safe only within a small dosing range. In other words, too little active ingredient and the drug doesn’t work; too much and it becomes toxic. NTI drugs include antiseizure medication for treating epilepsy, blood-thinning drugs like warfarin, antiarrhythmics for controlling irregular heartbeats, and drugs that help prevent the rejection of a transplanted organ. Several states have restricted generic substitutions of NTI drugs, and last year an FDA committee recommended that the agency tighten bioequivalence standards for them.

This has been an ongoing issue for people with epilepsy. In 2006 the American Academy of Neurology recommended that pharmacists not substitute generic versions of antiseizure drugs for people with epilepsy without their consent and their doctor’s. The concerns stem from anecdotal reports of treatment failures, such as an increase in epileptic seizures, after patients switched from a branded to a generic medication. Observational studies involving epilepsy patients who switched to generic versions reported higher switchback rates to branded drugs than for other classes of drugs, and more epilepsy-related doctor visits, hospitalizations, and prescription drug use.

Those studies, however, contradict the findings of randomized controlled trials. For example, a 2010 meta-analysis conducted by Kesselheim and his colleagues comparing brand-name antiepileptic drugs with generics found no difference in seizure control in seven such trials. But the trials were small and had other limitations. Another 2010 study reported increased seizures around the time the prescription was refilled—whether it involved a switch from brand to generic, generic to generic, or even a refill of the same medication. This might be due to a brief lapse in treatment during the refilling process, or to slight variations between different drugs or different lots of the same drug produced by the same manufacturer.

Cardiovascular drugs were investigated in a 2008 meta-analysis of 38 randomized controlled trials, also conducted by Kesselheim and his colleagues. They found no evidence that brand-name heart drugs worked any better than their generic versions. The analysis included NTI drugs such as antiarrythmics and the blood thinner warfarin (Coumadin), as well as drugs to lower blood pressure, cholesterol-lowering statins, and the antiplatelet drugs aspirin and clopidogrel (Plavix).

For NTI drugs, particularly those to treat epilepsy, our medical consultants recommend staying on a generic made by one manufacturer to avoid slight variations that may occur with different manufacturers. Talk with your pharmacist to ensure that he or she can provide that consistency month-to-month, or at least tell you if the pharmacy switches its generic supplier. If you do switch to a different generic or from a brand to a generic, your doctor may want to monitor your response more closely during the transition period.

Bottom line

When your doctor prescribes a drug, ask if there is a generic version that would be just as safe and effective but less expensive. If one isn’t available, as is the case with many newer brand-name drugs, ask if a generic version of an older drug in the same class would work as well. 

Keep in mind that branded and generic drugs can contain different inactive ingredients that may alter their look and taste. That won’t affect how they work. But if you’re allergic or sensitive to lactose or gluten—which may be used to fill and bind pills—ask your pharmacist to verify the ingredients in the product you receive. Or go to DailyMed, which has a searchable database of package inserts. Although they’re written for health-care professionals, not consumers, they can be helpful. You can usually skip to the section of the package insert titled “Description” to find the list of inactive ingredients.

For products such as inhalers, the transition from brand to generic may involve a device that looks or operates a little differently. Ask the pharmacist to show you how to use them.   

Learn the generic and brand names of your medication to avoid taking multiple versions of the same drug.

To find out if your medication is available as a generic, go to DailyMed. If you know the drug’s active ingredient, search using that; search results with multiple manufacturers indicate the generic is probably available. (If you don’t know the name of a drug’s active ingredient, search by proprietary (brand) name to find it.)

Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).
   

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