Simeprevir deaths?

[Sarah1949]

Have you all heard about the three deaths in Japan attributed to Simeprevir Sodium? Do you think this is the same as the Simeprevir (Olysio) here in the States?

"According to the Ministry of Health, Labor and Welfare, taking the drug will increase "bilirubin" by decomposing hemoglobin in the blood and may aggravate dysfunction of the liver and kidney."

http://www.globalpost.com/dispatch/news/kyodo-news-international/141024/3-die-after-being-administered-hepatitis-c-drug

[hrsepwrguy]

They do but they don't seem to do anything in a hurry, it took them over a year to change the on box warning for incivek

After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.

FDA encourages health care professionals and consumers to report problems with medical products, including

    unexpected and undesirable side effects
    quality problems, such as a drug with an unusual odor or color, or a device with defective parts
    unclear or confusing instructions
    failure to deliver the expected benefit.

Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.

    Online
    Regular Mail: Use postage-paid, pre-addressed FDA form 3500
    Fax: 800-FDA-0178
    Phone: [phone]

MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.

Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm335899.htm

[Sarah1949]

This is all such a puzzle to me. It seems like everyone assumes the FDA keeps track but I really do not think so. How could they? I guess it's the kind of thing that if something goes seriously wrong it comes out in the wash. Ah well...

[hepcandme]

Hey Ruby

I found at a support group meeting that insurance companies do not even share their data with one another!

That is so crazy to me. In the same city, the same drugs, similar patients and they are keeping the data to themselves?

That's not good science

[Sarah1949]

I suppose the bottom line for me is that even IF the two should be the very same drug and it did indeed cause three deaths, would I still treat with it. Yes, I would because to me unless I get rid of the hcv then I will die from the hcv. I just don't understand why people want to take these drugs without seeing how they affect people over the long haul, or at least a year or two, unless they already have cirrhosis. If I were healthy and newly diagnosed with the virus, really, what would waiting a year or two matter?

[flyinlynn]

The thing I am having trouble with is from what others have found Sovariad and Olysio apprer to me different chemically but yet I have found on Johnson & Johnsons / Janssen press release

http://www.jnj.com/news/all/OLYSIO-simeprevir-Receives-FDA-Approval-for-Combination-Treatment-of-Chronic-Hepatitis-C

"Janssen is responsible for the global clinical development of OLYSIO™ and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for OLYSIO™ in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved in September 2013 in Japan under the trade name SOVRIAD™ and in November 2013 in Canada under the trade name GALEXOS™ for the treatment of genotype 1 hepatitis C"

and that originally Janssen asked for approval of Olysio under the name Sovriad but were not approved by the FDA due to concerns Sovriad might be confused with Sovaldi

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205123Orig1s000NameR.pdf

So I am confused from what I have read at the FDA site and Janssen ir seems like only a name change and that for what wver reason the went with a lower dose in Japan. But then some of the chemical information folks are bring up do seem to be in conflict with Janssens press release.

So I have given up trying to figure out this one and just go with be careful out there folks. These are potent meds no matter what they are called and we should all be aware of that when treating.

Hope we all get to say we are free of hep c one day
Lynn

[dontworry_behappy1]

Great answer Dee.   Makes it easy for everyone to understand.  Very direct and to the point.  

Best to you