Official Guidelines For Duration of Use of Weight Control Medications:
The drug-labelling information found in medication package inserts for various
prescription weight control medications say the following:
Xenical or Alli: Indefinate
Meridia (Sibutramine): no more than 2 years
Phentermine: no more than 3 months
Phendimetrazine: no more than 3 months
Diethylpropion: no more than 3 months
These guidlines are generally developed at the time that a prescription drug is
first approved for market and they are based upon the best information
What Does the Official Labelling Mean?
It means that the FDA has reviewed premarketing (and in the case of updated
labelling, postmarket) clinical trial data for a given medication and made a
reasonable determination of how medications are best used for maximum
benefit and minimum risk.
Are FDA Prescribing Guidelines "The Law"?
They certainly are the law for drug manufacturers and they clearly are not, in
and of themselves, the law for prescribing physicians. Doctors are not
recquired by the FDA to follow official labelling guidelines. IN fact, the FDA is
very clear that they have no ability to regulate the practice of medicine.
Generally, this authority is left to the various States.
In some sense therefore, the FDA avoids the question of wether it is wise to
use medications in a manner different than their labels suggest. Still, the
question is begged and the answer lies within one of the most basic concepts
of medicine: the "risk-benefit" question.
The widely held opinion of "off-label" use of prescription medication is that it is
permissible when the best current evidence (peer-reviewed medical data)
shows that the risk of doing so is clearly outweighed by the likely benefit.
Therefore, physicians, as prescribers, are given the authority, generally, by
their respective state licensing authorities to prescribe medications in a
manner different than the official guidelines suggest PROVIDED that such
off-label use is based upon peer-reviewed scientific data and that it is
'judicious'. In plain English, if a doctor believes a patient will have substantial
benefit from off-label use, AND if that belief is based in accepted science,
then the physician may do so after informing and obtaining the consent of the
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