Cellcept linked to PML

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Cellcept linked to PML

Postby rainer » Fri Apr 11, 2008 3:33 pm

Again it looks like a very low risk and possibly from a combination of drugs... but I would really like to take PML out behind the shed and have a word with it.

FDA investigates CellCept and Myfortic PML risk



The FDA is investigating a possible link between the use of CellCept (mycophenolate mofetil, from Roche) and Myfortic (mycophenolic acid, from Novartis) and the development of progressive multifocal leukoencephalopathy (PML).

The FDA is reviewing Roche’s PML cases and the proposed revisions to the CellCept labeling. The FDA has also asked Novartis for their PML data and requested that they revise their Myfortic prescribing information to include the same information as Roche’s proposed CellCept revisions. Until further information is available, clinicians should be aware of the risk of PML with CellCept and Myfortic therapy and should monitor for localized neurologic signs and symptoms.

CellCept is approved to prevent heart, liver, and kidney transplant rejection and Myfortic is approved to prevent kidney transplant rejection.

For more information call Roche at (800) 526-6367, Novartis at (888) 669-6682, or visit http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate.

Another article where they provide more context: FDA Launches Safety Review of Two Antirejection Agents
User avatar
rainer
Family Elder
 
Posts: 367
Joined: Thu Jan 17, 2008 4:00 pm

Advertisement

Postby marcstck » Fri Apr 11, 2008 11:16 pm

This is troublesome, especially since I am doing CellCept in combination with intrathecal methotrexate. Got my second methotrexate shot last week, and I've been feeling very crummy ever since.

Told the neuro's office how I've been feeling, and the doctor responded by prescribing acyclovir, three times a day. Don't know if this was prompted by PML concerns, or general immune suppression concerns.

I think this news will prompt me to stop taking CellCept for the time being. Seems that PML is especially prevalent in patients that do combination immunosuppressive therapies, which is just what I'm doing now.

I should add, that the combination therapy has not benefited my MS symptoms one iota...
User avatar
marcstck
Family Elder
 
Posts: 560
Joined: Tue Jan 03, 2006 4:00 pm

Postby rainer » Sat Apr 12, 2008 10:18 am

For what it's worth, I read in one of the related articles that Novartis (Myofortic) has no reported cases of PML. I don't know what the differences are between the two drugs in question (Cellcept vs Myofortic). Also what drug combinations are causing problems seems to be iffy. Also don't remember reading about any MS patients being involved. good luck, marc.
User avatar
rainer
Family Elder
 
Posts: 367
Joined: Thu Jan 17, 2008 4:00 pm


Return to Drug Pipeline

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users