Sugammadex Disapproved ???

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Monty Python

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Schering-Plough's Drug Sugammadex Rejected by U.S.

> Aug. 1 (Bloomberg) -- Schering-Plough Corp.'s drug sugammadex for the
> reversal of general anesthesia was rejected by U.S. regulators.
>
> Schering-Plough, based in Kenilworth, New Jersey, received a
> ``not-approvable'' letter from the Food and Drug Administration, the
> drugmaker said today in a statement. Schering-Plough said it would
> work with the agency to ``address the issues, which are primarily
> related to hypersensitivity/allergic reactions.''


Anyone heard otherwise?



.
 
I read the same thing. I am surprised somewhat because everything I had read prior made it look like reactions were minimal. But given the current FDA culture I suppose it's expected.
 
2ndyear said:
I read the same thing. I am surprised somewhat because everything I had read prior made it look like reactions were minimal. But given the current FDA culture I suppose it's expected.
Click to expand...

Interesting!
Usually when the problem is allergic reactions that exceed the acceptable average that were evident on the initial studies the drug wouldn't make it this far, so I am assuming they have new reports of severe reactions from actual clinical use, reminds me of the short history of Raplon.
 
trinityalumnus said:
Schering-Plough's Drug Sugammadex Rejected by U.S.

> Aug. 1 (Bloomberg) -- Schering-Plough Corp.'s drug sugammadex for the
> reversal of general anesthesia was rejected by U.S. regulators.
>
> Schering-Plough, based in Kenilworth, New Jersey, received a
> ``not-approvable'' letter from the Food and Drug Administration, the
> drugmaker said today in a statement. Schering-Plough said it would
> work with the agency to ``address the issues, which are primarily
> related to hypersensitivity/allergic reactions.''


Anyone heard otherwise?

.
Click to expand...

Here's a copy of the Schering presentation. The allergic reactions were ONE patient in the healthy volunteer study. Look on page 146.
http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4346s1-01-Schering-Plough-corebackup.pdf

The problem is that the FDA is no longer capable of properly evaluating drug safety. They will take the politically expedient choice every time. Faced with the potential of any adverse reaction and the political consequences, they prefer to reject the drug. Of course this leaves the only other option which has many more side effects and adverse reactions.

To tell you how dysfunctional the organization is here is the quote from the commissioners bio:
* The post of commissioner was vacant from Jan. 19, 2001 until November 2002. Bernard A. Schwetz served as acting principal deputy commissioner from Jan. 21, 2001 until Feb. 24, 2002. At that time, Lester M. Crawford Jr. was appointed deputy commissioner and he headed the agency until Mark McClellan was appointed commissioner in November 2002. With Dr. McClellan's departure in March 2004, Dr. Crawford was again named to lead FDA, this time as acting commissioner.

The next full time commissioner was named in July of 2005 and lasted two months.

David Carpenter, PA-C
 
So does this mean suggamadex is no longer going to happen????
 
I'm sure it has to do with $$ - they were probably paid off by the makers of neostigmine. Seriously though, i thought sugammadex was just a sugar ring - it really shouldn't have major side effects.
 
leaverus said:
I'm sure it has to do with $$ - they were probably paid off by the makers of neostigmine. Seriously though, i thought sugammadex was just a sugar ring - it really shouldn't have major side effects.
Click to expand...

It's a cyclodextrin (like Febreze!), which is a polymer, I suppose, of 6-carbon-sugars (the number of sugars varies by type of cyclodextrin), but I don't think we can infer that it's safe just because glucose is safe. It was built to bind steroid molecules (like rocuronium), and I wonder if maybe there are other steroid molecules that might also get bound by it and, subsequently, excreted. Like cortisol, for example. Or sex hormones. Cholesterol.
 
apma77 said:
So does this mean suggamadex is no longer going to happen????
Click to expand...

There's a process in place to appeal the decision, so I'm sure Schering-Plough is already working on that. However i can't recall any decisions ever being reversed on appeal, and the quick search I just did didn't yield any. Anyone know of a drug that was initially rejected only to be later approved on appeal?
 
Kubed said:
There's a process in place to appeal the decision, so I'm sure Schering-Plough is already working on that. However i can't recall any decisions ever being reversed on appeal, and the quick search I just did didn't yield any. Anyone know of a drug that was initially rejected only to be later approved on appeal?
Click to expand...
It happens, they will probably have to do more studies though. At least the studies can be done fairly quickly with anesthesia. Its not like you have to repeat a five year outcomes study for a statin. The problem is that how big a study to you have to do to prove that another allergy reaction will happen. When the divisor is one it gets pretty tough.

David Carpenter, PA-C
 
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Everyone is excited about suga-ma-dex because it's a new, novel drug to play with. The reality is that it will not have broad day-to-day practical applicability anyway because it will be priced not to sell. You just generally don't need such a drug unless you are routinely going to the trauma bay.

-copro
 
Drug wold be a grat drug to keep in the fridge an use once every six months - for instance when the usually slower surgeon actually rips through a case and you're caught with a non- or minimally reversable patient! Dont really need it in day to day practice.

Had SUGA been approved, I doubt I would have used it for a coupla years anyhow - I woud have liked to see the open market data first.
 
Planktonmd said:
I used Prodafalgan (the IV pro drug of Acetaminophen) in Europe in 1990.
That's 18 years ago 🙂
Click to expand...

i thought paracetamol.
perhaps it's not a pro-
 
coprolalia said:
Everyone is excited about suga-ma-dex because it's a new, novel drug to play with. The reality is that it will not have broad day-to-day practical applicability anyway because it will be priced not to sell. You just generally don't need such a drug unless you are routinely going to the trauma bay.

-copro
Click to expand...

I disagree. I would use it all the time. I think it has a very broad day-to-day application. Just having it in the drawer would make me feel much more comfortable on the people I think might be a difficult mask or intubation - I would not think twice about paralyzing those patients to make my job easier, but without it, one would think twice before you cross the rocuronium bridge - not any more with suggamadex.
 
dfk said:
i thought paracetamol.
perhaps it's not a pro-
Click to expand...

2g of Prodafalgan (a paracetamol ester which has a better water solubility)would give you after metabolism 1g of paracetamol but it's been replaced by Perfalgan or Perfusalgan which is 1g of paracetamol in 100ml.

PLank where did you work in europe?

flaskor_neu_litenfor-web.jpg
 
epidural man said:
I disagree. I would use it all the time. I think it has a very broad day-to-day application. Just having it in the drawer would make me feel much more comfortable on the people I think might be a difficult mask or intubation - I would not think twice about paralyzing those patients to make my job easier, but without it, one would think twice before you cross the rocuronium bridge - not any more with suggamadex.
Click to expand...

Yeah, yeah, yeah. Same thing was said about remifentanil... 🙄

-cop
 
coprolalia said:
Everyone is excited about suga-ma-dex because it's a new, novel drug to play with. The reality is that it will not have broad day-to-day practical applicability anyway because it will be priced not to sell. You just generally don't need such a drug unless you are routinely going to the trauma bay.

-copro
Click to expand...

I think S-P would be smart enough to price it aggressively, otherwise it definitely would be a hard sell in today's environment.

Precedex isn't on our hospital formulary because of the cost. Nicardipine is, but almost nobody uses it because of the cost.
 
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dhb said:
2g of Prodafalgan (a paracetamol ester which has a better water solubility)would give you after metabolism 1g of paracetamol but it's been replaced by Perfalgan or Perfusalgan which is 1g of paracetamol in 100ml.

PLank where did you work in europe?

flaskor_neu_litenfor-web.jpg
Click to expand...

France
 
hmmm. sucks. a rep just told me they were expecting approval in sept...guess that ain't gonna happen.
roc is going generic in a couple months, right?...should help with the whole cost thing.
 
coprolalia said:
Yeah, yeah, yeah. Same thing was said about remifentanil... 🙄

-cop
Click to expand...

Except we've always had a fast acting, side-effect free reversal agent for opiates. Remifentanil is a neat drug, but it's still searching for a solid indication where it's the drug of choice.

Neostigmine and edrophonium are both imperfect, limited, and inelegant drugs for reversing neuromuscular blockade. If sugammadex turns out to be safe and side-effect free it's hard to imagine why it wouldn't eventually become the standard means of reversing NMBDs (cost permitting).


How long after administering sugammadex can one use nondepolarizers again? If you use it at 10 AM, will you be stuck using a succ drip for NMB at 4 PM for an unexpected return to the OR?
 
pgg said:
Except we've always had a fast acting, side-effect free reversal agent for opiates. Remifentanil is a neat drug, but it's still searching for a solid indication where it's the drug of choice.
Click to expand...

I use remi for all of my general CEAs. Makes for a beautiful wake-up.
 
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pgg said:
Except we've always had a fast acting, side-effect free reversal agent for opiates. Remifentanil is a neat drug, but it's still searching for a solid indication where it's the drug of choice.

Neostigmine and edrophonium are both imperfect, limited, and inelegant drugs for reversing neuromuscular blockade. If sugammadex turns out to be safe and side-effect free it's hard to imagine why it wouldn't eventually become the standard means of reversing NMBDs (cost permitting).


How long after administering sugammadex can one use nondepolarizers again? If you use it at 10 AM, will you be stuck using a succ drip for NMB at 4 PM for an unexpected return to the OR?
Click to expand...

supposedly the T1/2 of sug is about 1.5-2 hrs...so, there's your apparent answer...
is this the "standard"?
i wouldn't bet my attorney on it....
"porque el tiene un edge"...
 
apma77 said:
So does this mean suggamadex is no longer going to happen????
Click to expand...

Ultimately, I think that Suggamadex will get approval in the US, and it very well might happen sooner than later. Since Suggamadex was approved by the EU, within a few months or so it will be available for general use in those countries. After hundreds of thousands of doses are administered, it will be clear if there are any significant adverse drug reactions, and if so, how often they occur.

- Dan
 
pgg said:
Except we've always had a fast acting, side-effect free reversal agent for opiates.
Click to expand...

I take it you've never seen pulmonary edema or seizures after the administration of naloxone?


pgg said:
Remifentanil is a neat drug, but it's still searching for a solid indication where it's the drug of choice.
Click to expand...

Remi is an excellent choice with propofol for neuroanesthesia cases, especially where SSEP monitoring is being used, because higher concentrations of inhaled agents interfere with SSEP. I also prefer using it in combination with lower concentrations of inhaled agents for some and ENT cases, and cases with prolonged tourniquet times.


pgg said:
How long after administering sugammadex can one use nondepolarizers again? If you use it at 10 AM, will you be stuck using a succ drip for NMB at 4 PM for an unexpected return to the OR?
Click to expand...

I would imagine that one could use a benzylisoquinolinium NMBA such as cisatracurium (Nimbex), since they're structurally dissimilar to steroid NMBAs and thus Suggamadex cannot bind with them.

- Dan
 
Last edited:
Wrong - there is nothing benign about narcan. Especially when some nurse who doesn't know any better pushes the whole amp (400mcg). When you have to reintubate go for the bubbles.

pgg said:
Except we've always had a fast acting, side-effect free reversal agent for opiates. Remifentanil is a neat drug, but it's still searching for a solid indication where it's the drug of choice.

Neostigmine and edrophonium are both imperfect, limited, and inelegant drugs for reversing neuromuscular blockade. If sugammadex turns out to be safe and side-effect free it's hard to imagine why it wouldn't eventually become the standard means of reversing NMBDs (cost permitting).


How long after administering sugammadex can one use nondepolarizers again? If you use it at 10 AM, will you be stuck using a succ drip for NMB at 4 PM for an unexpected return to the OR?
Click to expand...
 
This really pisses me off. Just approve the drug. It works. It is safe. Any reaction or hypersensitivity will be seen quickly in use. We can always pull the drug.

What do I need to do to practice in Europe? I hear they have nice food.
 
Doctor Dan said:
I take it you've never seen pulmonary edema or seizures after the administration of naloxone?
Click to expand...

No, I haven't - only read about it and got the impression that these were extremely rare events. Thanks for correcting me.

Doctor Dan said:
I would imagine that one could use a benzylisoquinolinium NMBA such as cisatracurium (Nimbex), since they're structurally dissimilar to steroid NMBAs and thus Suggamadex cannot bind with them.
Click to expand...

Good point; hadn't considered that.
 
If nothing else, they ought to at least approve it for use in emergency situations when you've given roc for whatever reason and can't intubate. Let's face it, there are times when you don't want to intubate with sux but you do want to intubate quickly, so you go for the roc. While these events are infrequent, what's the problem with having it around? I'd take the risk of allergic reaction if I couldn't intubate somebody and I had given a larger dose of roc to intubate quickly. I think the patient would agree with me too.:idea:
 
milrisome said:
If nothing else, they ought to at least approve it for use in emergency situations when you've given roc for whatever reason and can't intubate. Let's face it, there are times when you don't want to intubate with sux but you do want to intubate quickly, so you go for the roc. While these events are infrequent, what's the problem with having it around? I'd take the risk of allergic reaction if I couldn't intubate somebody and I had given a larger dose of roc to intubate quickly. I think the patient would agree with me too.:idea:
Click to expand...

i wonder if they compared the high incidence of side effects of roc versus the one documented reaction to sugammadex.
in the balance, benefit seems to outweigh risk here...
 
Anyone hear anything new on the frontlines with this drug? One of my attendings told me he heard it is quickly falling out of use in Europe now, although I cant remember why and cant seem to find anything new on the topic.
 
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