Actemra FDA approved

[Nruble]

For those of us in the US, it is great to note that the FDA has expanded the use of Actemra (tocilizumab) to treat giant cell arteritis in adults. This is the first FDA-approved therapy for GCA, granted under a breakthrough therapy designation and priority review.

[christine2715]

Have you seen the other post below in which Roche/Genotech - is being sued because 1200 people have died after taking Actemera so it might be that this might cause some stalling of the supply of it to patients.

[Nruble in reply to christine2715]

I had missed those. Thanks for pointing out. I wonder how it even got through the approval process now.

[christine2715 in reply to Nruble]

You have to consider that 700,000 have taken it Worldwide so maybe 1200 is not such a large figure as it sounds.

[PMRpro Ambassador in reply to christine2715]

It isn't the numbers that people are complaining about - it is the fact the company never mentioned these potential adverse effects. I'm happy to take responsibility making a decision if I have all the facts. But if I only have some of them it is a very different matter.

Given this - it is one thing using it for GCA where there are much higher risks, both of loss of vision and from high dose pred, and a very different thing putting a patient with PMR and already on a low dose with few problems on it.

[30048]

Yeah.... my insurance will cover the infusion but I am still on the fence. They called to set up my appointment five minutes after i read the post. Good timing 😋

[GOOD_GRIEF]

You should do a Google search on the USA class action suit for this drug. It appears it has a higher incidence of heart and stroke related deaths than similar drugs, and this was not previously disclosed in the literature or warnings.

[piglette in reply to GOOD_GRIEF]

Remember this is a class action so there is a firm of lawyers with their eyes on the winnings, who are encouraging people to join the class action. People may have died while taking actemera, but we don't know what else was wrong with them as well. They may have died without taking Actemera. They are not saying that actemra is not working, it is just that they did not put all the possible side effects on their literature.

[GOOD_GRIEF in reply to piglette]

1200+ and counting died of stroke/heart related problems, the risks of which were not disclosed in the PPI. In fact, many doctors and patients selected this drug because they believed these risks were minimized in comparison to other choices, and now it may very well turn out that the risks are escalated.. I think that indicates a problem.

Yes, it is true in the US that law firms make money if their case is successful. You might also want to note that they take on all the risks and get no compensation at all if they can't prove their case. It's also true that law firms have brought a number of similar cases over the years against drug manufacturers, and turned out to be right.

All I'm saying is be informed, assess the risks in light of all the facts (even the ones we don't like), and make your choices carefully.

[Nitrobunny]

I took it for 9 months and wrote several replies and posts about it. It helped for a brief while but I developed a severe allergic reaction to it. The side effects being reported to the FDA are adding to the data base of previously disclosed side effects but many are reporting even more that weren't previously listed. Not entirely uncommon. I was able to wean more quickly than I would have been able to without it BUT just in the last week I had to go back up over 20 for what I'm hoping is going to be a short time and begin the weaning process again.

[Marie1479]

I am on Actemra and it has changed my life!! Down to 4mg and finally feeling normal. If you google any biological or Prednisone you will get hits on all kinds of horrible lawsuits. I have never felt better and almost off steroids. I'm a fan.