holy crap. I’ve been on cellcept for lupus since fall 06. I’m on a lupus chat group and now it seems like they’re giving *everyone* with lupus cellcept, even those with no major organ involvement, which I think is irresponsible. first of all, much as I hate the crap, prednisone works much faster and has a longer track record. Second of all, again, I do not like the drug but it works, Prednisone is like $4 a month and cellcept is $800. EIGHT HUNDRED. I know, because even though I had prescription coverage last year, i still paid $5000 out of pocket for drugs. About 95% of that was for cellcept.
I can only say the drug reps must be doing a helluva a job schmoozing up the doctors and convincing them to prescribe this expensive, unproven drug to every lupus patient (and there are millions of us, so what a racket!) Someone’s getting a new Beemer and a vacation in Rio. And someone else is getting an early grave (PML).
>>>>
FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic
ROCKVILLE, Md., April 10, 2008–FDA is investigating a potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.
PML is a rare disorder that affects the central nervous system. When it occurs, it is usually in patients with immune systems suppressed by disease or medicines. It happens when the polyomavirus, also known as the JC virus, is activated. The JC virus is found in most adults but does not usually cause symptoms. Scientists do not know exactly how the JC virus is activated. Once activated, the JC virus attacks the cells that make myelin, the protective coating around nerve cells. Signs and symptoms of PML can include localized neurologic signs and symptoms including vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs. Many patients who develop PML die. Patients who survive may have permanent disability due to irreversible nerve damage. More information on PML can be found at the National Institutes of Health website.
CellCept is approved to prevent heart, liver, and kidney transplant rejection and Myfortic is approved to prevent kidney transplant rejection. Mycophenolate mofetil, the drug ingredient in CellCept, is metabolized by the body to mycophenolic acid, the drug ingredient in Myfortic. Both CellCept and Myfortic are used with other drugs to suppress the immune system.
On November 8, 2007, Roche, the maker of CellCept, submitted an evaluation of its PML cases in patients who have received CellCept in addition to other immunosuppressive medicines. Roche also submitted recommendations to the FDA for including information about PML in the CellCept prescribing information. On March 14, 2008, Roche informed the FDA of the Dear Health Care Professional letter it issued in Europe on February 18, 2008.
Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE), an autoimmune disorder that is sometimes treated with CellCept; however, CellCept and Myfortic are not approved for treating SLE or similar autoimmune disorders.
FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information.
FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revised prescribing information for CellCept and Myfortic about PML. As soon as FDA completes the review, FDA will communicate the conclusions and recommendations to the public. Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic. Decreasing total immunosuppression may improve the outcome of patients who develop PML.
This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
Yes, it's killing people, but more importantly (the cha-ching):
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
....More than 500,000 patients worldwide have used CellCept, which brought in more than $2 billion Swiss francs ($1.99 billion U.S. dollars) in 2007, according to the company....
Sales of a multiple sclerosis drug, Biogen Idec Inc’s and Elan Corp Plc’s Tysabri, were suspended in 2005 amid three reports of PML.
The drug returned to the market in 2006 with limits, when the FDA decided patients were willing to accept the risk in light of the drug’s benefits.
The agency said it has also asked Novartis for related data and called on the drugmaker to update its prescribing information on Myfortic’s label. The drugmaker does not provide specific sales figures for Myfortic because it is not one of its top 20 products.
In a statement, Novartis said while it “is not aware of any instances of PML in patients using Myfortic, we will comply with the class label change requested by FDA.”
Shares of Novartis were off 3.9 percent, or $1.90, at $47.27 in afternoon trading on the New York Stock Exchange; earlier they closed down 2.8 percent in Switzerland. Shares of Roche closed down nearly 1 percent on the Swiss exchange. (Reporting by Susan Heavey; editing by Gerald E. McCormick and Dave Zimmerman)
Showing posts with label cellcept. Show all posts
Showing posts with label cellcept. Show all posts
Tuesday, April 15, 2008
Monday, March 17, 2008
The Devil You Know
The reaction I had to reading the prednisone literature when i was finally
diagnosed in 1993... "Osteoporosis, diabetes, hair loss, high blood pressure, frequent infections, mood swings,weight gain, cataracts, acne, insomnia"... was "Not no, but *hell* no!"
I refused to take it because of all the short and long term side effects. I figured I could just deal with the pain and the whole thing would eventually sort itself out. I kind of think of it as "the devil you know"- meaning I was used to being exhausted and in pain. Those were known entities. But osteoporosis and cataracts? Weight gain and acne that I couldn't control? I wasn't ready for that. So, I did not take anything, and I got sicker and sicker and sicker and nearly died. It did not help that I went to the rheumatologist who literally cussed me out for not taking the prednisone, without addressing my concerns and educating me. Finally, months later, and with a different doctor, my will was broken and I took the stupid prednisone. It saved my life. It also made my hair fall out, my face blow up, my skin look horrible, and I was so anxious i thought i would climb the walls (if I could just get out of the chair).
As soon as I had some energy, I started seeking out alternative medicine so i could do things to help me get off
the prednisone before it killed me!
So if you're sitting there with lupus not wanting to go on any meds because they are toxic (they are) or you think "I can take it"- you can't go on like this. don't be a hero. get some relief. chronic pain is tough on your soul and chronic inflammation is tough on your organs. you gotta get some relief.
After I got off the prednisone following about 9 months on it, I went for years just putting up with the pain and
inflammation (again, but I wasn't debilitated this time- yet) because i did not want to go back on the
prednisone. This time I knew that prednisone devil, and the lupus devil. And I still chose the lupus devil. That's how crappy being on prednisone is. Did I mention it tastes like rat poison?
After 16 years living with this thing i can tell you, it's not just going to go away by waiting it out, and
the inflammation is very dangerous. It can raise your blood pressure, send you into heart or kidney failure, damage your organs and put you at 18 times greater risk for stroke. i had 2 strokes in 2002. i am fully recovered now but the road was long
and hard and I'm still paying the bills on that one!
Yes, some of the drugs used to treat lupus are very toxic and can cause other diseases if you're on them long enough. But here's the thing- you can die from lupus, too, and a lot sooner than you would if you had instead been on the meds. My advice (to myself) When the lupus is flaring out of control, get on the meds, get the thing under control, then improve your diet, lifestlye, environment (workplace and home) and stress management and get back off the drugs.
I'm not a fan of taking pharmaceuticals, but it has become a necessary evil at points in my life. For those of us with painful chronic diseases who have to at least temporarily take something so we can get back on our feet and deal with this thing properly, maybe it will (literally) be an easier pill to swallow if you promise yourself that as son as you feel better, you will start seeking out some natural ways to heal yourself that you can do alongside the prednisone/ cellcept/ whatever you're taking, so that you waon't have to be on it so long that you develop lymphoma or something else gnarly (like unpayable credit card debt!).
We can get better. It's not all devils.
diagnosed in 1993... "Osteoporosis, diabetes, hair loss, high blood pressure, frequent infections, mood swings,weight gain, cataracts, acne, insomnia"... was "Not no, but *hell* no!"
I refused to take it because of all the short and long term side effects. I figured I could just deal with the pain and the whole thing would eventually sort itself out. I kind of think of it as "the devil you know"- meaning I was used to being exhausted and in pain. Those were known entities. But osteoporosis and cataracts? Weight gain and acne that I couldn't control? I wasn't ready for that. So, I did not take anything, and I got sicker and sicker and sicker and nearly died. It did not help that I went to the rheumatologist who literally cussed me out for not taking the prednisone, without addressing my concerns and educating me. Finally, months later, and with a different doctor, my will was broken and I took the stupid prednisone. It saved my life. It also made my hair fall out, my face blow up, my skin look horrible, and I was so anxious i thought i would climb the walls (if I could just get out of the chair).
As soon as I had some energy, I started seeking out alternative medicine so i could do things to help me get off
the prednisone before it killed me!
So if you're sitting there with lupus not wanting to go on any meds because they are toxic (they are) or you think "I can take it"- you can't go on like this. don't be a hero. get some relief. chronic pain is tough on your soul and chronic inflammation is tough on your organs. you gotta get some relief.
After I got off the prednisone following about 9 months on it, I went for years just putting up with the pain and
inflammation (again, but I wasn't debilitated this time- yet) because i did not want to go back on the
prednisone. This time I knew that prednisone devil, and the lupus devil. And I still chose the lupus devil. That's how crappy being on prednisone is. Did I mention it tastes like rat poison?
After 16 years living with this thing i can tell you, it's not just going to go away by waiting it out, and
the inflammation is very dangerous. It can raise your blood pressure, send you into heart or kidney failure, damage your organs and put you at 18 times greater risk for stroke. i had 2 strokes in 2002. i am fully recovered now but the road was long
and hard and I'm still paying the bills on that one!
Yes, some of the drugs used to treat lupus are very toxic and can cause other diseases if you're on them long enough. But here's the thing- you can die from lupus, too, and a lot sooner than you would if you had instead been on the meds. My advice (to myself) When the lupus is flaring out of control, get on the meds, get the thing under control, then improve your diet, lifestlye, environment (workplace and home) and stress management and get back off the drugs.
I'm not a fan of taking pharmaceuticals, but it has become a necessary evil at points in my life. For those of us with painful chronic diseases who have to at least temporarily take something so we can get back on our feet and deal with this thing properly, maybe it will (literally) be an easier pill to swallow if you promise yourself that as son as you feel better, you will start seeking out some natural ways to heal yourself that you can do alongside the prednisone/ cellcept/ whatever you're taking, so that you waon't have to be on it so long that you develop lymphoma or something else gnarly (like unpayable credit card debt!).
We can get better. It's not all devils.
Tuesday, December 4, 2007
fighting to get better
So, i've been on 7 drugs for over a year to manage my health problems (this is part of the reason that CD #4 of wacky Carla songs hasn't occurred yet. that and moving, and planning our wedding). I've decided I'm tired of popping all these F**king pills and more tired of paying for them, so I'm back on the warpath to getting better and getting back off these drugs (for the 3rd time in 15 years).
A month or so ago I quit drinking diet coke. I've been addicted to it for lord knows how long, even though I know it's toxic. Then I bought this sport water bottle that has a built in water purifier (which does more than just a water filter) and have been drinking copious amounts of clean water (it also saves me money on bottled water when I travel, and who knows how clean bottled water is anyway?). here's a report on the amazing healing powers of water. you know, drinking it. I jsut finished reading adn online report:
The Water Cure: An interview with Dr. Batmanghelidj
(how often do you think he gets called "Batman?"). So many problems in the body when we get dehydrated. Then when we're thirsty we drink stuff that dehydrates us even more- coffee, soda, alcohol.
Anyway, next step i started getting acupuncture again. It's been several years and I really respond well to acupuncture. I stopped going when I moved to NJ, and finally restarted. The acupuncture gave me enough energy to start taking guitar lessons once a month which makes me happy. Being happy is good for your health too :)
I also got some really good vitamins and mercury free fish oil. I'm hoping to be my old perky self sometime in 08. well not OLD as in OLD, but old as in former, before the health fiascos. ;)
had to post something healthy- i am after all the singing patient! (i may have to change my name in 08 after I get off all these pills! I like to think big. Worst case, I'll just feel great instead of awesome.)
www.thesingingpatient.com
A month or so ago I quit drinking diet coke. I've been addicted to it for lord knows how long, even though I know it's toxic. Then I bought this sport water bottle that has a built in water purifier (which does more than just a water filter) and have been drinking copious amounts of clean water (it also saves me money on bottled water when I travel, and who knows how clean bottled water is anyway?). here's a report on the amazing healing powers of water. you know, drinking it. I jsut finished reading adn online report:
The Water Cure: An interview with Dr. Batmanghelidj
(how often do you think he gets called "Batman?"). So many problems in the body when we get dehydrated. Then when we're thirsty we drink stuff that dehydrates us even more- coffee, soda, alcohol.
Anyway, next step i started getting acupuncture again. It's been several years and I really respond well to acupuncture. I stopped going when I moved to NJ, and finally restarted. The acupuncture gave me enough energy to start taking guitar lessons once a month which makes me happy. Being happy is good for your health too :)
I also got some really good vitamins and mercury free fish oil. I'm hoping to be my old perky self sometime in 08. well not OLD as in OLD, but old as in former, before the health fiascos. ;)
had to post something healthy- i am after all the singing patient! (i may have to change my name in 08 after I get off all these pills! I like to think big. Worst case, I'll just feel great instead of awesome.)
www.thesingingpatient.com
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