You have a sore back and are prescribed an anti-depressant? Don't
laugh, it happens more often than you'd think. It's called off-label
use, a practice which refers to the use of an approved drug to treat
anything outside the scope of the drug's labelling. A friend's mother,
for instance, is taking an anti-seizure medication for her chronic
pain.

As I understand it, anti-depressants may be prescribed to help people
quit smoking. And I'm told that in cancer therapy, a drug effective in
treating one kind of cancer may be used to treat another even though
it wasn't approved for that purpose.

Even over-the-counter drugs are used for reasons that are not
indicated. Can't sleep? Pop a Gravol at bedtime.

According to the Journal of Head and Face Pain, off-label prescribing
is not uncommon in treating headaches and is within the current
standard of care.

Anti-epileptics and newer anti-depressants are treatments that
apparently help control chronic headaches -- and they're not even
related to painkillers.

This past May, an article in the Archives of Internal Medicine shed
further light on the practice by reporting an enormous study of 725
million prescriptions written in the U.S. in 2001 (this represented
about half of the total number of prescriptions written that year).
The authors found that 21% of the total were for off-label usage, the
majority of which lacked strong scientific evidence.

Looked at more closely, of the 18 million prescriptions for
psychiatric drugs in this study, 17 million apparently looked pretty
thin evidence-wise. Only 11% of the off-label uses of allergy
prescriptions were backed by solid evidence. The three types of drugs
most likely to be prescribed off-label are anticonvulsants, tricyclic
anti-depressants, and anti-inflammatory pills. Who knew?

The study's authors found that some of the off-label uses were logical
(an asthma drug prescribed for other lung diseases, for example), but
others were for conditions dramatically different from those for which
the drug was approved. Off-label drug prescribing is common throughout
the world. I read that, in India, pharmacists were concerned that an
anti-ulcer drug was used for terminating pregnancy and that in one
study, 25% of the drugs prescribed in a French surgical unit were
off-label.

According to the authors of the study published last May, prescribing
off-label "brings greater latitude to turn scientific knowledge into
innovative clinical practice." There's nothing legally wrong with it.
I'm sure most docs won't prescribe off-label without having confidence
in a drug's "other" effectiveness -- from either reading studies or
having had experience over the years with a particular treatment.

Drug manufacturers are actually not allowed to market a drug for its
off-label use, though Health Canada allows companies to report
scientific studies in the form of press releases regarding off-label
use. But I bet that drug companies would just love to promote
off-label use because doing so can dramatically drive drug sales. Just
look at how hormone replacement therapy's profits soared in days past
when physicians assumed estrogen (originally to prevent osteoporosis)
offered heart and stroke protection for post-menopausal women: The
"fountain of youth" it promised became a cesspool when studies showed
that HRT increased the risk of diseases, including breast cancer.

Botulin toxin, approved for the treatment of muscle spasms, was only
somewhat profitable before its huge economic success as Botox -- a
popular cosmetic anti-wrinkle treatment. There's certainly a dark side
to off-label use: For example, one breast cancer drug had been used
confidently as a fertility drug until Health Canada warned doctors a
few years ago that the drug tripled the risk of fetal abnormalities.

The bottom line? Be informed. If the drug recommended to you is for an
off-label use, talk frankly to your doctor and address the risks and
benefits of the medication. Explore why the doctor feels that
particular drug may be more effective than the use of an approved
drug. Ask him or her what gives them the confidence to support the
off-label use of that drug. It's your body -- and you should know what
goes into it.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 8:28 PM