Why Buy Generic Drugs?
Generic Drugs: The Facts
Generic drugs are made with the same active ingredients and produce
the same effects in the body as their brand-name equivalents. By federal
law, each generic drug is laboratory-tested to ensure that the same
amount of drug will be absorbed into the bloodstream. The difference?
Name and price.
The brand name of a drug is the name under which it was originally
marketed, and is protected by patent for up to 20 years. When this
patent expires, other manufacturers can produce the generic equivalent
of the brand and sell it under its generic name. In general, the cost
to the consumer immediately drops by 20 to 30 percent. Within two
years, the price is usually up to 60 percent less.
Are generic drugs safe?
In almost all cases, generics work as well as their brand-name siblings,
and often cost considerably less. This is possible not because of
lower quality, but because research and advertising costs are much
less for generics. Many insurance plans encourage you to accept the
generic version of a drug whenever it's medically safe. Most states
let pharmacists substitute a generic when appropriate and when your
doctor approves it.
Are Generic Drugs As Good?
In most cases, the answer is "yes," Generic drugs are as
safe and effective as brand-name products, and subject to the same
quality guidelines set by the Food and Drug Administration to ensure
their therapeutic equivalence. They're not inferior. People mistakenly
believe cost is equivalent to quality."
Generic drugs must contain an identical amount of active ingredients
as their brand-name counterparts, and in the identical dosage. The
generic drug must deliver the same amount of those active ingredients
into a patient's bloodstream and within the same time frame as the
original drug. It must also fall in "acceptable parameters"
established by the FDA for bioavailability, which is the extent and
rate at which the body absorbs the drug.
So besides price, the only real difference between brand-name and
generic drugs tends to be the inactive ingredients used that have
no medicinal value. These include fillers, binders, coloring and flavoring,
which may explain why generics may differ in the size or shape of
pills or capsules.
Will it be as effective as the brand name
drugs?
Manufacturers of generic drugs have to meet the same FDA requirements
as the brand name drugs. They must prove that their product provides
the same dosage, the same amount of active ingredient, and falls within
the same range of bioavailability as the original. They do not have
to prove that it works to treat depression or that it is safe for
human consumption, however. In theory, this has already been proven.
In general, the generic you get should be the same as far as therapeutic
effect. There may be slightly different inactive ingredients such
as the dyes, fillers, etc., but these are only of concern if you happen
to have an allergy to them. The active ingredient will be virtually
the same as the brand name product, although the extent and rate at
which the drug enters your blood stream may vary slightly. This occurs
because pills are manufactured to fall within a certain range of bioavailability,
rather than to fall on a precise value.
When shouldn't generics be substituted
for brand-name drugs?
Very few drugs have a "narrow therapeutic index," meaning
that a small variation in dose can cause problems, such as too little
effectiveness or too many side effects. With some drugs, including
phenytoin (brand name Dilantin), carbamazepine (Tegretol), valproic
acid (Depakene), divalproex sodium (Depakote), digoxin (Lanoxin),
warfarin (Coumadin), lithium (Lithobid, Eskalith), levothyroxine (Synthroid,
Levoxyl), and theophylline (Theo-Dur), you shouldn't switch from brand
to generic-or vice versa-without your doctor's approval and close
supervision. Always talk to your doctor, pharmacist, or both before
asking for a substitute.
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