A couple of years ago, I was sitting in a doctor’s office talking to him about insomnia. Not being able to sleep can take a devastating toll on the quality of one’s life. I had multiple medical problems that made sleep difficult, and I was concerned about taking a sleeping pill. The doctor then wrote me a prescription for something and handed it to me, saying, “Don’t ask me what it is… just take it and see if it works.”
He laughed and I did too, because he knew that wasn’t something I would or could do. I am the type who researches everything my doctors give me. In this instance, what he had prescribed was a medication called amitriptyline. This drug is classified as a tricyclic antidepressant. I wasn’t depressed, so why did the doctor prescribe this?
Off-Label Medication Uses
Sometimes, when a drug has been on the market for a long time, there accumulates a body of evidence that supports the side effects of the medication that didn’t necessarily result in the clinical trials. While many of these side effects-such as dry mouth, nausea, etc-are ‘negative’ in nature, there are some that can be beneficial. With amitriptyline, one of the beneficial side effects is that people reported better quality of sleep and better ease in falling asleep when taking a low-dose of the medication, a dose that is not a physiologically therapeutic dose for depression, but that works wonderfully for insomnia.
Interestingly enough, amitriptyline also was discovered through ‘side effects’ to help prevent and lessen the pain and frequency of migraine headaches and cluster headaches. The problem is, since these ‘side effects’ of the medication never were tested by clinical trial and reported to the FDA for approval, using the medication for these purposes is called ‘off-label dispensing’.
Doctors believe the medication works, but technically, they aren’t supposed to prescribe it for those purposes.
Is it Illegal to Prescribe Off-Label Medication?
A report by Consumer Reports indicates that one in five prescriptions written today by doctors are written for a purpose other than what the FDA has approved it to be written for on the medication’s label. They further report that up to 75% of those prescriptions have no evidence to prove the medication actually does what the off-label use says it will do. This does essentially mean that when a patient takes the medication, it’s hit or miss whether it will work for them.
But one can argue that this is the case with any medication, even when used exactly as the FDA requires for labeling. After all, every person is different and different medications work differently on different people. In other words, what works well for one person might do nothing for another, and yet there is no rhyme or reason why this is so. So in that sense, off-label prescribing is not that much more hit or miss than prescribing to the FDA required labels.
But is it legal to prescribe off label? Absolutely! The only issue at that point is the caution the patient and the doctor should take when using a medication for a purpose that it was not intended.
What to Watch for with Off-Label Prescribing
When I was a child, my neurologist prescribed me a medication for a tremor disorder that was really supposed to be used for lowering blood pressure. Since my blood pressure was below normal to normal to begin with, I had to watch my blood pressure closely to ensure this medication didn’t lower the blood pressure too much. This was an off-label use of the medication that could have resulted in a negative side effect from the actual on-label use of the drug.
Whenever a doctor prescribes a new medication, it’s important for the patient to be their own advocate. Research all medications, read the label, prescribing and dispensing instructions and warnings. Know what you are taking, what it’s supposed to be used for, and why you are taking it. If it’s an off-label use, ask your doctor why he or she is prescribing it instead of something that is made for that condition.
Off-label prescribing often is beneficial to the patient, but it’s still important to be informed and prepared when advocating for your own healthcare. Off-label prescribing is nothing to fear, but all medications should be respected and side effects reported and progress monitored. Remember, you and your healthcare professional are a team in ensuring the best health for you, so be sure to educate yourself about your medications, particularly when they are dispensed for off-label uses.