Generic Drugs: Not Always The Same?
In the world of prescription drugs, generic equivalents have been a financial blessing for many patients, saving them millions, if not billions, of dollars each year. For the most part, they perform the same function as brand name drugs at a fraction of the cost. A recent article in the New York Times, however, has indicated that some generic drugs might not work as well as their brand name counterparts.
The evidence thus far, however, has been largely anecdotal. People have reported on various websites, including People’s Pharmacy, that when they switched to generic drugs, either they did not work as well or they experienced adverse side effects. The take home message from all of this is that not all drugs are created equally, and generic equivalents might in fact not do as good of a job at alleviating ones’ symptoms.
This is of particular concern when the medication involves ailments whose side effects can seriously affect a person’s health, including the fields of cardiology and neurology. In fact, the American Academy of Neurology has gone so far as to say that they are not in favor of generic substitutes for certain anticonvulsant drugs (for treating epilepsy) without proper physician’s approval.
The issue, to say the least, is controversial. The insurance industry is particularly supportive of generic drugs and often insists that they be used (or else incur a penalty in the form of higher co-payments), and the Food and Drug Administration (FDA) as well as the American Medical Association (AMA) both agree that generic drugs work just as well as brand names. But there are an increasing number of incidences that seem to tell a different story, and the growing wave of concern is causing the field of medicine to take notice.
Generic drugs are essentially a cheaper alternative to brand name medications. When a new drug hits the market, it maintains patent protection for twenty years. When the patent expires, other drug makers can rush into the market and sell the drug at a lower price.
According to the FDA, the generic equivalent must have “the same active ingredient, dosage form, and strength,” as its brand name counterpart, though not necessarily identical. It must also be bioequivalent, which means that it must result in blood levels of the active ingredient that are very similar to the brand name drug.
To be considered bioequivalent, the generic drug must achieve blood serum levels that are 80% to 125% of the reference level, a range that some experts feel is too wide and might possibly result in the reduced absorption, and thus effectiveness, of a drug. This is especially important when treating heart conditions and seizures.
Interestingly, the differences might even be of concern when switching from one generic brand to another, and the patient might not even be aware of the change due to the fact that pharmacists are not obligated to inform them of it.
For now, there have not been any well established clinical studies that offer concrete evidence that generic drugs are in fact less effective, and experts contend that in most instances, generic drugs work just fine.
If you have concerns, speak with your physician. If you have questions about the brand or makeup of your medication, discuss your concerns with your pharmacist of insurer.
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