Prescribing Outside The Box

Kurt writes in with a very common question:

I was prescribed 70mg Vyvanse for debilitating chronic fatigue. The 70mg was totally ineffective. At 6′2″, 220 pounds, I think the dosage was too small. My psychiatrist will not increase the dosage. I self-titrated and found that 210mg will get me through the working day but I’m exhausted by 6:00PM. Can Vyvnse be prescribed above 70mg?

Short answer . . . NO!!!! . . . . . . . well . . . . . maybe.

Now, back to reality . . .

This simple question is actually a very, VERY complicated question that involves hoards of lawyers, government agencies and reams of legal pads that, in the end, leave us doctors and you patients buried up to our you-know-what in red tape and potential litigation.  Bottom line is that all medicines that are used on the market come with prescribing limits and recommendations. Deviating from those FDA approved limits and guidelines is not automatically a risk . . . but it is outside the bounds of safety as defined by the FDA . . . and you know how reliable THEY have been. Many medicines are used in this manner, but it is important for the patient to know that the doctor is operating outside of the FDA guidelines for the medicine.  There is a concept of the “standard of practice” that gives relative legal safety for the use of medicines outside of the FDA guidelines.  Because approval often lags way behind clinically accepted usefulness, use of medicines can become the standard even without approval.  A good example of this the use of Tenex for irritable kids.  Tenex is approved as an anti-hypertensive agent for adults but is rarely, if ever, used for that.  For the last 15 years or so it has been used extensively for irritable ADHD kids . . . because it works so well.  Unfortunately for the company who held the patent, the patent expired just as this use was identified and they reaped none of the benefit of it.  They also had no incentive to run the studies that could be brought in front of the FDA for approval for that use.   Use of Tenex is now a standard of practice, but it is not approved for that use.  Another interesting example is Depakote.  Again, Depakote has been used as a mood stabilizer for 15 years or more, but only received FDA approval as a mood stabilizer for Bipolar Disorder five or six years ago.  The science finally caught up with doctor and patient experience.  If we limit ourselves to FDA approved uses only, we in the world of psychiatry will find ourselves very limited.  Lets use Kurt’s experience as an example.

Kurt presented to his doctor with symptoms that were diagnosed (according to Kurt) as “debilitating chronic fatigue”. He was prescribed Vyvanse . . . OOOOOOPPPPPSSSSS, Vyvanse is not approved for chronic fatigue. We are already outside the limits of FDA prescribing practices that approve its use only for treating ADHD.

Kurt is an adult . . . OOOOOPPPPPPSSSSSS, Vyvanse only received approval for use in the 6-12 year age group at first.  If Kurt received his first prescription before April 23, 2008 he was DOUBLY outside the FDA guidelines which initially only included kids with ADHD that were ages 6-12.  To be honest, I can’t find any notation that indicates approval for use in kids ages 13-17 either.  Interesting.

Kurt likes mega-doses of Vyvanse . . . OOOOOPPPPPPSSSSSSS, 210 mg is three times the FDA recommended maximum dose!!!  

Alright, alright . . . enough fun.  What are we to do here . . . like in a practical sort of way.  

First off, what is the diagnosis?  Does Kurt actually have ADHD or does he have chronic fatigue?  I would strongly suggest that he get a comprehensive physical exam (should be done before the use of stimulants anyway) to make sure that nothing is being missed. How much sleep are you getting?  What is the quality of your sleep?  Evaluation of your sleep in a reputable sleep center is mandatory to make sure that your fatigue is not based on poor quality sleep.   If it is determined that you have ADHD, then there is a wide range of options that can be used to treat it, including Vyvanse.  If it is chronic fatigue, there are other meds that can be used.  Medicine such as Provigil can be very helpful for treating chronic fatigue without as high a risk of cardiovascular issues in adults.  It also does not have the late day “let down” that is not uncommon with stimulants.  If your issue is really poor quality sleep, there are ways of improving that without medication (and sometimes with medication).

Stimulant medication such as Vyvanse are used (off-label) to treat symptoms of chronic fatigue.  You may have over-shot your dose and may be taking way, way too much.  That’s what happens when you have to go up in 70 mg increments.    I do prescribe over the FDA limits for a medicine.  But it must be done carefully and thoughtfully.  In adults, it must also be accompanied by significant monitoring of blood pressure, EKG etc to make sure that your risk of catastrophic cardiovascular events are not raised excessively.  Your doctor is not being a stick in the mud, he is just trying to practice safe medicine.  Don’t give him a hard time.  That said, your condition may be helped by prescribing outside the FDA box.  You must understand that when you accept doses above these guidelines, you are accepting additional risk.  You may need to find a doctor who will work with you, but it is YOU who must be willing to accept the risk.  

But, as mentioned above, the first thing you need to a good physical work-up to make sure an underlying medical issue is not being missed and to make sure that you are physically healthy enough to accept doses of stimulants above that which is the accepted FDA limits.

–Dan Hartman, MD


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