Posted by Bea Smith on March 1, 2016, at 19:16:06
In reply to Cylert (liver failure), posted by rjlockhart37 on March 1, 2016, at 0:56:40
When Cylert was being prescribed in the U.S., for adults beginning with the medication standard operating procedure was:
- The treating physician would closely monitor the patient for signs of hepatotoxicity.
- In the rare cases where test results would indicate a negative effect on the liver, the physician would take the patient off the medication (permanently) and the liver would heal itself.
- If after a year of monitoring no hepatotoxicity was indicated, Cylert was considered permanently safe for that patient. If a warning sign were to appear, it would appear during the first 12 months.
The statistical risk was low, but it *was* higher than that of the general population.
This would seem to be moot for you, because not only is Pemoline (generic for Cylert) no longer produced in this country; it's a felony to bring any into the United States.
There is only one company in the world that still manufactures Pemoline, and to get it you have to locate one of the 2 clinics in that country can prescribe it. (It's a very different system than the one in the U.S., where any pharmacy can order virtually any medication if authorized by a physician.) It is so rarely prescribed that most physicians in that country never have heard of it.
*Theoretically* you can get Pemoline in the U.S. (legally): A few years ago, the FDA announced that Pemoline could be prescribed, but only as a "Compassionate Use Investigational New Drug." They authorized a single pharmacy in the U.S. to import and compound the Pemoline powder, and technically it's available right now.
The idea is to treat Pemoline as a "new" drug if it's described for treating conditions other than ADHD, e.g., Narcolepsy or Excessive Daytime Sleepiness.
THE CATCH: In order to be prescribed Pemoline, the patient has to have a sponsor-investigator for an IND (Investigational New Drug). That process involves so much paperwork that no practicing physician will do it. An IND application usually is made by research physicians, often employed by pharmaceutical companies or universities.
poster:Bea Smith
thread:1086620
URL: http://www.dr-bob.org/babble/20160131/msgs/1086637.html