Lamictal

[MikeLima]

If lamictal was prescribed as a mood stabilizer by a primary physician with no diagnosis of any psychological issues other than patients statements regarding high levels of irratibility, is there a path to obtaining a medicAl? Can patient quit using the drug and, assuming there is no more issues, get cleared?

Obviously, he can't take this drug while flying but is the fact that he has taken it for 1.5 years disqualifying going forward?


Thank you.

ML

 

[flyingron]

Lamictal is 100% not allowed. It's also off label, but it is used when other more conventional therapies (antidepressants don't work). Even notwithstanding the drug, irritability to the point of needing "mood stabilizers" is a pretty strong sign of depression. This is almost certainly going to be deferred to the FAA. The FAA will want to see him off the drugs and have a full PPP work up (which is going to result in several thousand dollars worth of tests as well as another thousand or so to be examined by a suitable psychiatrist (probably HIMS AME these dasy) to determine his actual condition).

This is going to be a tough one. He can consult with Dr. Bruce (or Dr. Bruce may pop in here), but this one doesn't look optimistic.

 

[MikeLima]

Thanks for the reply. What does "off label" mean? Does that mean prescribed for something other than its usual purpose?

I think his doc screwed him on this... This was the first medicine prescribed and I'm not sure why the doc didn't start him on something more conventional and which would have an easier pathway.

 

[flyingron]

Every drug that is approved has to state for what conditions it is prescribable for and these are the ones that are proven in the clinical trials. Lamictal only is approved for anti-seizure purposes.

I suspect the doctor did screw him, but frankly, if he had to be prescribed ANYTHING for this condition, he's likely going to have issues with the FAA.

 

[lbfjrmd]

stop the drug wait about a month and go see your AME. He will know what to do and airman will eventually be able to fly if there are no other physical or mental issues

 

[James331]

stop the drug wait about a month and go see your AME. He will know what to do and airman will eventually be able to fly if there are no other physical or mental issues

So just go see your local yokal AME?

I'm starting to see the humor in you having a quack in your profile picture.

You just want to make troubles for folks?

I would NEVER see a AME if the outcome was in question.

To the poster, call Dr.Bruice, he specializes in this type of thing, he's also very well known on these boards.

He will be able to tell you what's what, and if possible he can help you put a packet together BEFORE your OFFICIAL medical application.

http://www.aeromedicaldoc.com

 

[Doggtyred]

Thanks for the reply. What does "off label" mean? Does that mean prescribed for something other than its usual purpose?

I think his doc screwed him on this... This was the first medicine prescribed and I'm not sure why the doc didn't start him on something more conventional and which would have an easier pathway.

When a drug manufacturer submits a drug for trials and testing, its a very expensive process.. Kind of like certifying an airplane, but even more expensive and onerous. Only the conditions studied in the trials and testing are considered for "On Label" usage. These On Label conditions are the only things the drug manufacturers can market and advertise the drug for. The purpose of the trials is to 1) see if it does what its supposed to do and 2) see if it is relatively safe.

Once the drug is in common usage, people taking the medication for an on-label condition will notice it helps with other conditions...and report this... Post marketing trials by the drug maker will also pick up on this sort of thing. Clinicians not affiliated with the drug maker will pick up on these additional benefits, and may prescribe these medications for "off label" conditions for their therapeutic benefit. Some of these off label uses get studied... but unless the drug maker spends the money on the expensive, rigorous studies to move an off label condition "on label" it remains "off label.

Lamictal is generic now. No manufacturer is going to go through this to add stuff on-label when they wont be able to enjoy the cost-recovery of being on patent. Even if it would otherwise be proven effective in those rigorous studies. Off label use is purely at the discretion of the prescriber, but its rarely quackery or reckless medicine.

 

[flyingron]

Correct, but still this is a drug that the FAA is never going to accept. Further, the condition it's being used for may be disqualifying in its own right. The person needs to have a frank discussion with a good AME.