Tuesday, April 15, 2008

Are they trying to get rid of us? Dangers of Cellcept

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).

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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.

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Yes, it's killing people, but more importantly (the cha-ching):

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....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)
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