They’re cheaper but can be inferior to brand-name drugs…
Generics cost 80% less, on average, than brand-name drugs. They contain the same active ingredients and supposedly do the same job. What’s not to like? A lot, it turns out. In June, two large manufacturers of the generic version of the heart drug Toprol-XL issued a recall because the drug wasn’t dissolving properly—a problem that was identified when patients taking the drug started complaining of chest pain and other heart symptoms.
This isn’t an isolated incident. Generic drugs may be similar to their brand-name counterparts, but they are not identical. What you need to know about generic drugs…
DOUBTS ABOUT QUALITY
For years, major medical groups such as the American Heart Association (AHA) have expressed concerns that generics may cause more side effects than brand-name drugs-and the AHA as well as many other such groups advise always getting a doctor’s approval before using a generic drug.
Generics account for about 80% of all prescriptions in the US and save Americans billions of dollars a year, but some experts worry that patients, in some cases, are trading quality for economy—and may be taking serious risks.
Sobering statistics: A survey of more than 500 doctors found that nearly 50% worried about the overall quality of generics…and more than 25% said that they would hesitate to prescribe these drugs for themselves or their families.
Key differences between generic and brand-name drugs…
• Bioequivalence. You would think that the amount of a drug that’s absorbed by the body would be the same in generic and brand-name versions. This isn’t always the case.
According to FDA guidelines, generics are required to reach maximum blood concentrations that are between 80% and 125% of the levels achieved by brand-name drugs. Suppose that you switch to a generic that delivers medication at the low end of the range. You may find your symptoms aren’t as well-controlled as they used to be. If the drug is at the high end, you’ll be more likely to have side effects.
• Timed-release. Medications that release their active ingredients slowly are among the trickiest to copy. Even when the active ingredient is the same in two versions of the same drug, how it is released in the body might be different.
• Fillers. The active ingredients in generic and brand-name drugs are the same, but the extra ingredients—such as binding agents, preservatives and pill coatings—may be different. These ingredients are supposed to be inert. But new research suggests that they may affect how drugs dissolve or how they’re absorbed by the body.
• Testing. The same investigational drug studies that are needed for FDA approval of brand-name drugs are not required for all generic drugs. For example, the FDA requires only a very small number of people (sometimes just 20) for its bioequivalence studies.
HOW TO PROTECT YOURSELF
There’s no reason to swear off generic drugs. The cost savings can be tremendous, and most generics provide the same benefits—with no greater risk for side effects—as brand-names. But you have to choose them carefully. My advice…
• Be wary of timed-release medications. Also called extended-release, they are used for conditions such as pain, depression and asthma that require long-term control…or for convenience. They’re usually designated with abbreviations such as ER (extended release), LA (long acting) or LTR (long-term release).
Problems with the timed-released components are more of an issue with generics than with brand-name drugs. This doesn’t mean you should avoid generics. What matters is the predictability of the timed-release drug. If your symptoms are well-controlled by a generic version, stick with the same drug—preferably one that’s made by the same manufacturer (see below). You’re more likely to have problems when you first switch from a brand-name drug to a generic substitute.
• Take exactly the same drug. Pharmacies use generic products from multiple manufacturers. Different drug companies use different manufacturing techniques as well as different ingredients. Even if you think you’re taking the same drug, there may be subtle variations in such areas as effectiveness and side effects each time the prescription is filled. You can avoid these variations by making sure that your prescription comes from the same company.
What to do: Check the prescription bottle for the manufacturer of the drug you take. If it’s not there, your pharmacist can tell you. Also, ask him/her if it’s possible to use a single company for each refill.
This is crucial if the drug has a narrow therapeutic index (NTI)—a fine line between an effective dose and a toxic dose. Examples: Some blood-thinning drugs (such as warfarin)…drugs used for seizures (such as phenytoin)…and antipsychotic drugs (such as lithium).
• Track results. Be suspicious if a drug that you’ve been taking for months or years suddenly seems less effective or seems to be causing new side effects. It’s possible that your condition has changed—or you could be receiving a drug made by a different manufacturer.
Important: If you start using a new pharmacy, let the pharmacist know the manufacturers of all your medications. Also, ask your doctor to give you copies of all your test results. Track your numbers—for cholesterol and blood sugar, for example. If you notice a change, tell your doctor right away. It’s possible that you just need a dosing adjustment. It’s also possible that a generic isn’t the best choice for you.
• Switch drugs. If you’re not getting the best results from a new generic medication, don’t assume that you need a different drug. You might simply need to switch to the brand-name version.
What to do: Ask your doctor to prescribe the brand-name drug for a few months. If you notice an improvement in your symptoms and test results, it might be worth sticking with it even if it costs more. Or if you are not happy with the results of your generic but would rather avoid the high cost of a brand-name, ask your pharmacist to recommend another generic.