Actemra being sued???

[Buddyk]

Why is actemra being sued?

[Hidden]

So glad you picked up on this, a class lawsuit has been filed in the USA against the company. I just started to gather info so I will just add the page where you can all read. The company failed to list serious side effects like heart attacks and lung issues. Deaths have also been mentioned as a result. Read more here:

nationalinjuryhelp.com/acte...

[Klah in reply to Hidden]

This is why my rheumy told me to stop googling everything and then stressing out about it. Everyone is suing everyone all the time. All drugs can have serious side effects....prednisone included.

Some patients in the trials for Actemra had other serious health issues which contributed to their death. We are all responsible for the choices we

make. It is our job to research and gather the information we need to make those choices....then live with them.

Life is full of risks and choices...and personal responsibility. I Google everything, but you have to scrutinize what you read.

[piglette]

It seems it is a class action taking place in the US regarding the side effects of Actemra. They say that it is linked to life-threatening side effects including heart failure, pancreatitis, stroke and lung disease, which apparently the supplier Roche does not warn against. It seems a law firm is advertising to get people to join in the class action.

[PMRPete]

"Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients"

statnews.com/2017/06/05/act...

"The Law Offices of Howard G. Smith Announces the Filing of a Securities Class Action on Behalf of Roche Holding AG Investors and Encourages Investors to Contact the Firm"

businesswire.com/news/home/...

It seems to be investors in the company, NOT patients.

"On June 5, 2017, news reports stated that a new study showed that adding Roche’s breast cancer drug Perjeta to its older treatment Herceptin only had a slight benefit, while more than doubling the one-year treatment cost; and that the combination of Perjeta with Herceptin had higher rates of certain side effects than Herceptin alone, including severe diarrhea.

In addition, also on June 5, 2017, an investigation by STAT revealed that Roche’s rheumatoid arthritis drug Actemra has been associated with heart attacks, strokes and heart failure at least as often as some competing drugs despite not carrying the same warnings in its prescribing information. Following this news, Roche shares fell $1.75 per share, or over 5%, to close at $34.14 per share."

[piglette in reply to PMRPete]

Having worked with the drug industry for the last thirty five years, it seems this is very much par for the course. Pharmaceutical companies seem to spend their time in law suits. Patients take out a law suit then the investors take one out because their shares are falling. I am not saying the lawsuits are not valid.

[Marie1479 in reply to piglette]

I read this as I got on the airplane to Florida. As you can imagine it upset me. When I arrived in BWI to meet up with my RN Nurse, she hugged me and calmed me down and said exactly what piglette said. She said to Google class action lawsuit for a few biologics and Prednisone. As I thought got a hit on all of them.

[piglette in reply to Marie1479]

Hi Marie, it looks very like lawyers trying to make money again. They are not knocking the product they are saying they did not print all the supposed side effect warnings.

[Marie1479]

A lot is misspellings in this article. I would be VERY suspicious of this claim.

[HeronNS in reply to Marie1479]

This looks pretty genuine: spglawfirm.com/defective-dr...

[kulina in reply to HeronNS]

Great article HeronNS!

[kulina]

I think this is the disturbing part: "However, while other manufacturers choose to warn the medical community and public of these risks, Roche/Genentech does not." It gave doctors and patients a false sense of security and the FDA is no help in this matter. If it weren't for the lawsuits we still wouldn't know about the high risks.

[PMRpro Ambassador in reply to kulina]

That is actually the purpose of the yellow card system in the UK and the FDA warning system in the USA. It is impossible to see side-effects of longterm use of any drug until it is in widespread use in real life. ANY adverse event should be reported - but many doctors don't understand the reasons "It's a known side effect..." But it is the way the real incidence of any side-effect is assessed - and especially the longer term sequelae.

And I think Roche does have form in this respect.

[kulina in reply to PMRpro]

PMRpro I found this one to be the more informative article spglawfirm.com/defective-dr...

and this is what the FDA is saying: "To date, the FDA’s response has been that it lacks the necessary, sophisticated tools to determine that Actemra is the cause of the 1,128 deaths.

“We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective,” said Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University. “The system is broken, and all the financial incentives are lined up to keep it broken.” "

I personally have no confidence at all in the FDA, some of the people who run the FDA are former pharma executives. Unfortunately, money speaks in the US.

[PMRpro Ambassador in reply to kulina]

Yes, I read that too.

But it cuts both ways with the FDA I think. The companies hold back or manipulate the analysis of information that would reduce the likelihood of their wonder-drug being approved for wider use. That was the case for statins - while they may be valuable for men and also women with a history of a cardiovascular event, there is little value in their use in women with no such history. But they pooled the results to make the effect in the entire population speak more loudly - otherwise they would have lost about a third of their target population.

There is little argument against using Actemra in GCA where the patient's sight is at risk. But if this increase in cardiovascular events is to be seen, it should lead to pause about the use of it in PMR unless it is a serious problem - which is unusual. RA patients already have an increased risk of cardiovascular risk - it is very complicated to sort out.

They did get there with Vioxx in the end - but how many people died unnecessarily? I don't mind taking some risks in the right context - but I DO want to be told about them. And since I do very well on a lowish dose of pred - however much I think after 13 years of PMR and 8 of pred it would be nice to PMR-free - I think I'll wait a bit longer.

[kulina in reply to PMRpro]

PMRpro I couldn't have said it better! I agree with you 100%.