Topamax

[lss]

Manufacturer Pleads Guilty to Illegally Promoting Topamax

 

 

Ortho-McNeil Pharmaceutical has pled guilty to illegally marketing the antiepilepsy drug Topamax (topiramate) for unapproved uses, according to the U.S. Department of Justice.

 

 

Prosecutors said that the company promoted Topamax to psychiatrists to treat psychiatric disorders. Topamax is only approved to treat seizures and prevent migraine headaches.

 

http://www.fda.gov/ICECI/CriminalInvestigations/ucm213163

[peglem]

Manufacturer Pleads Guilty to Illegally Promoting Topamax

 

 

Ortho-McNeil Pharmaceutical has pled guilty to illegally marketing the antiepilepsy drug Topamax (topiramate) for unapproved uses, according to the U.S. Department of Justice.

 

 

Prosecutors said that the company promoted Topamax to psychiatrists to treat psychiatric disorders. Topamax is only approved to treat seizures and prevent migraine headaches.

 

http://www.fda.gov/ICECI/CriminalInvestigations/ucm213163

I don't give a lot of weight to these things. If a practitioner finds a successful, off label use for a drug, who cares if its off label. Drugs are used off label all the time!!!

[Phasmid]

I don't get it, since so many meds are prescribed in unapproved situations. Look at the meds used on Tourette's patients.

[Fixit]

I don't get it, since so many meds are prescribed in unapproved situations. Look at the meds used on Tourette's patients.

 

exactly....and more so since since they have no clue in the last 50 years what causes it....but its on its way(autoimmune, inflammation)

[kim]

I think the problem is that they were promoting it which in my opinion is very very wrong, when they won't let the cherry growers say that cherry juice is a good natural anti inflam. out loud! If a med proff. decides to use it off label, that's one thing, but to actively promote it for something with nothing to back it up.....well, how many of us have been slammed for "anecdotal," when using a virtually zero side effect supplement. I think the situation described sounds like something that was needed to ward off the use of and SALES of drugs in a misleading manner.

 

prosecutor told the Court that had the case proceeded to trial, the Government’s evidence would have proven that ORTHO-McNEIL PHARMACEUTICAL, LLC ed a promotional program called the “Doctor for a Day Program” as a tool to promote its epilepsy drug, Topamax, for uses which had never been approved by the United States Food & Drug Administration (FDA). Through the “Doctor for a Day Program,” ORTHO-McNEIL PHARMACEUTICAL, LLC paid outside physicians to accompany sales representatives on sales calls, including to psychiatrists. On these sales calls, through the Doctor for a Day, ORTHO-McNEIL PHARMACEUTICAL, LLC promoted Topamax to psychiatrists, including some in Massachusetts, for psychiatric uses. However, ORTHO-McNEIL PHARMACEUTICAL, LLC had never applied to the FDA for any approval for Topamax to treat any psychiatric disorders and there was no data from any well-controlled clinical trial to demonstrate that Topamax was safe and effective to treat any psychiatric conditions

Edited May 27, 2010 by kim

[tantrums]

I take topomax for migraines. However at work, I see soooo many clients on it for behavioral issues. Topomax causes behavioral changes - often just the opposite of whatever the typical behavior is. I have been on and off of it I think three or four times. Each time it was completely different for me - very weird stuff! The first time, it made me extremely angry. I started to get out of my car to go after someone at a stop light bc he had been tailgating me! I lowered the dose after that. That is NOT like me at all!!! That effect did fade though. Another time, it made me very depressed.

 

IMO - it is a very unpredictable drug. And when used off label, I don't think they know what dosages to try. It also has some downright painful side effects.

 

That all said though - I'm not against off label usage As far as anti-epileptics go, it's not a bad one and if those are going to be tried, I would prefer anyone I love to try the topomax first. The others have much much worse effects across the board.

[kim]

Tantrums,

 

Thought you might want to check this out too. Just popped up this morning.

 

http://www.nature.com/nature/journal/vaop/...ature09041.html

 

Distinct FGFs promote differentiation of excitatory and inhibitory synapses

 

An imbalance in these synapses may lead to various neurological disorders such as autism, schizophrenia, Tourette’s syndrome and epilepsy1, 2, 3,

 

 

edit...oh, now I see that you said you were taking Topamax for migraines not epilepsy!

Edited May 28, 2010 by kim