Novartis announces 3rd case of PML with Gilenya

[Cherie]

Aug 17, 2015
Novartis has been informed of a third case of progressive multifocal leukoencephalopathy (PML) in a patient with relapsing MS (RMS) treated with Gilenya without prior exposure to natalizumab treatment. The patient also has a history of colorectal cancer treated with chemotherapy and radiation treatment in the past as well as Crohn’s disease (an inflammatory bowel condition).

The diagnosis of PML was based on suggestive clinical symptoms, MRI findings and tests for JC (John Cunningham) virus. Health Authorities have been informed of the case. Novartis is in active discussions with external advisors to review details of this case and the role of various risk factors contributing to the development of PML.

Patient safety is of paramount importance for Novartis and we recently updated the Gilenya prescribing information, in collaboration with Health Authorities, to increase vigilance for PML.

With more than 125,000 patients treated with Gilenya and 240,000 patient years of exposure in both clinical trials and post-marketing setting, Novartis continues to stand behind the positive benefit-risk profile of Gilenya in relapsing MS.

[agate]

I don't know if this earlier thread adds much more information but FWIW:

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[Howie]

I wonder how that patient even qualified to use Gilenya given their past medical history.

[Virginia]

Good point Howie!

[agate]

I have an impression that doctors are very eager to keep their patients happy, and sometimes whatever the patient wants, the patient gets. The patient (or his/her family) might have really leaned on the doctor to prescribe Gilenya. I've heard that this happens.

[Howie]

But the doctor takes the Hippocratic Oath, "Do no harm". Seems that was overlooked. Pleasing a drug company clouded the doctor's vision IMHO.

[agate]

Some doctors genuinely want to please their patients. After all, they want to keep those patients. They don't want us going to the doctor down the street instead.

And some of them will let the patients write their own tickets.

[Howie]

I agree, but it's not right. I don't think ANY drug that has resulted in PML should continue to be used, especially on one who had gotten Chemo, which strips the immune system hoping it had weakened the immune system enough to cause it not to attack the remaining immune system of the patient. I wonder how long after using Chemo they waited.

Where's SpongeBob?

[agate]

I agree with you. I'm all for doctors who let their patients make the decisions but there are times when a doctor needs to step in and emphatically advise the patient not to go a certain route or even refuse to prescribe a drug that the patient is insisting on.

PML is too terrible a disease to risk getting. At least I wouldn't want the risk. Others don't feel that way.

[Howie]

I'm with you Joan, if PML is even a chance with a certain treatment, I would have to say no thanks.

[agate]

In fact I have to admire the people who have been willing to try these drugs with the risk of PML. They're much braver than I am. The PML is usually very low but still.

Your question in post #8 has gone unanswered. Is SpongeBob MISSING?

[Frog42]

Is the thong missing too?

[Howie]

WHOOOOOOO LIVES IN A PINEAPPLE UNDER TH...SpongeBob, hold it down...and just because I have a SpongeBob thong doesn't mean you can wear it, now take it off.......in the other room please!

[SalpalSally]

I hate this Disease and all of the Money mongers using us to gain their fortune.
Find us a cure or go away.......... and quit poisoning us.

[Frog42]

I wish there was a way to thank Sally for that post several times!!