“Off-Label” for Pain
Using a drug a lot more for
what it’s NOT approved for. This is Dr.
Steven Andrew Davis, Speaking of Health.
Every FDA-approved prescription drug is “indicated” for at least one
disease or symptom. The drug gabapentin,
better known by its trade name “Neurontin™”, is FDA- approved “for treatment of
partial epilepsy” and for long-lasting nerve irritation – neuralgia – resulting
from shingles. Yet, according to the
Medical Letter on Drugs and Therapeutics, Neurontin™ is widely used “off-label”,
that is, for many types of chronic pain and other conditions for which the drug
is not FDA-approved.
For example, published
studies suggest that Neurontin™ can control pain seen in some diabetics –
so-called “diabetic peripheral neuropathy”.
There have also been reports, published and anecdotal, of Neurontin™’s
effectiveness in helping some patients with “other neuropathic pain syndromes,
going by names like trigeminal neuralgia, multiple sclerosis, neuropathic head
and neck pain and phantom limb pain.
There have also been published studies suggesting that Neurontin™ can be
more helpful than placebo in preventing migraine headaches.
In addition to using
off-label for chronic pain disorders, some physicians have given it to patients
to help them deal with social anxiety disorder and even attention deficit
disorder – even though, says the Medical Letter, “no good evidence that (it) is
effective for mood disorders or attention deficit disorder.
Is off-label use of this or
any other drug illegal? No. Is it unethical? Not if the physician has a rational reason
for trying it and it is safe for the patient.
Indeed, using Neurontin or any drug off-label creates opportunities to
discover new uses for drugs whose relative safety has already been
documented. For a copy of this script
and the journal reference, access our web site, www.speakingof
health.com. Speaking of Health, I’m Dr.
Steven Andrew Davis for CBS News.
Ref: The Medical Letter on Drugs and
Therapeutics. Vol 46.