Prior to approval from the Food and Drug Administration (FDA),
possible negative side effects of prescription drugs are often
determined in only small groups of people over short time
periods. Pharmaceutical companies also often publicize a drug
before all of its side effects are known. As a result, many
new drugs may be approved by the FDA without full knowledge
of their side effects, and previously unknown side effects
are reported to the administration only after some drugs have
already hit the market.
study in the Journal of the American Medical Association
determined the relationship between new prescription
drugs and the addition of "black box warnings" (warnings required
by the FDA to be placed on drug packaging that indicate potentially
severe or life-threatening side effects) or removal from the
market. The authors examined all new drugs approved from 1975-1999,
and all drugs withdrawn from the market for safety reasons
An estimated 20% of prescription drugs released to the public
during that time received a black box warning or were removed
from the market. Half of changes to drug warning labels occurred
within seven years of introduction; half of withdrawals from
the market took place within two years of introduction.
The safety of new drugs is uncertain until they have been
widely used for many years. Don't be one of the first people
to suffer a previously unknown side effect of a drug. If you
must take a prescription drug, opt for one that is tried and
true -- not the heavily marketed, newer one. Also, consider
alternative therapies besides drugs to treat your condition.
Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new
black box warnings and withdrawals for prescription medications.
Journal of the American Medical Association 2002:287(17),
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