TGA to withdraw dextropropoxyphene from Australian market

[Mr Blonde]

Aspen has been advised by the Therapeutic Goods Administration (TGA) that the registrations for analgesics containing dextropropoxyphene will be cancelled effective March 1st 2012.

This is NOT a recall.

Aspen is appealing the TGA's decision on the basis that the products are effective and well tolerated.

Aspen expects to run out of stock of Capadex (paracetamol 325mg + Dextropropoxyphene HCl 32.5mg) and Paradex (paracetamol 325mg + Dextropropoxyphene HCl 32.5mg) in the next few weeks and expects wholesalers and pharmacists to run out soon after.

Di-Gesic (paracetamol 325mg + Dextropropoxyphene HCl 32.5mg) stock, which expires in September 2014, and Doloxene (Dextropropoxyphene napsylate 100mg) should remain available until the end of February, however Aspen may run out of Di-Gesic stock before that time.

Stock held by patients after March 1st can still be used. Aspen will not accept the return of any unused packs from patients. As with any unused medication, the patient should discard safely.

Pharmacies with unsold stock can return it to their wholesalers for a full refund after March 1st 2012.

Aspen is asking pharmacists to inform patients who are having prescriptions for these products filled that the products will not be available after March 1st 2012 and that patients should visit their doctors to discuss alternatives.

As noted above, Aspen is in the process of appealing the decision to cancel the registrations, and understands the difficulties that doctors and patients will experience during the coming months. We will keep you informed as the appeal process continues and will write to you again early in the new year.

Some background information in this CNN article on the US Food & Drug Administration (FDA) decision to ban sales of dextropropoxyphene due to concerns over cardiac side effects and lack of efficacy.

Thought some BL'ers may find this interesting, even though it's not a popular drug for recreation.

 

[bobbydarren]

[]

Thought some BL'ers may find this interesting, even though it's not a popular drug for recreation.

That's a reasonable decision. I think it's banned most places. weak pain reliever but possibly a really good drug to commit suicide with. No positives, but a really strong negative.

 

[Mr Blonde]

^ I also believe it is a reasonable decision; it is obviously not a very effective analgesic, and the side effects it has can be quite concerning. I think this also highlights the need that Australia has for more mid-level analgesics; right now in the mid-range we only have codeine with paracetamol, tramadol, and then analgesics with more specific or limited uses such as the selective COX-2 inhibitors (for inflammation, particularly rheumatoid arthritis) or gabapentin and pregabalin (neuropathic pain). It would be interesting to have hydrocodone available again as a mid-range analgesic.

 

[bobbydarren]

. It would be interesting to have hydrocodone available again as a mid-range analgesic.

Yes I"ve always thought the same, unfortunately for skitish scared gp's it's got to be scheduled S4, maybe a hydrocodone/paracetamol combination might just make it in.

 

[Mr Blonde]

^ It's currently listed as an S8 drug with no qualifying statements, so the SUSMP would probably need to be amended so as to make hydrocodone/paracetamol combinations an S4 substance. Otherwise, even if it were available it's effective use as a mid-range analgesic would be limited by it's restrictive scheduling. The states and territories could even make it one of the S4 watched drugs, so as to have controls that they are comfortable with yet at the same time allow physicians to feel comfortable in prescribing it when suitable.

 

[bobbydarren]

I was looking at hydrocodone on wikipedia and noticed it's banned or at least not registered for use as a prescription medicine in many countries that you can get oxycodone in. Do you have any idea why this is?

I don't know but maybe it's recreational effects are greater then it's pain killing effects when compared to oxycodone. So for example to completely relieve the pain of a person in moderate to strong pain the dose of oxycodone will create less of a 'high' than the equivalent dose of hydrocodone.

There must be some reason it's not available in so many countries and yet oxycodone is. And that's likely the reason it'll never be a S4 in Australia.

 

[Mr Blonde]

^ At a glance, it seems as though in many of those countries hydrocodone is or was listed in a relatively high schedule, like here in Australia, compared to the USA. It's something to interesting to wonder about; I might take a guess that in many countries it was available as a single ingredient medicine, as opposed to a preparation like Vicodin (hydrocodone/paracetamol), and that this may have led to it being included in schedules with much stronger opioids where given that a doctor has to go through the processes in place for prescribing, they may as well use a more potent substance instead. I might see if I can dig up information on why it's use was ceased in Australia.

 

[Crankinit]

For once I'm glad to see Australia follow US policy. Good riddance to a useless & dangerous med.

The lack of mid range opioids in Australia has come up a few times on this board and I believe it's a real barrier to receiving adequate pain relief for some people. If codeine and tramadol don't suffice, it can seem like a big step for a prescribing doctor to jump up to oxycodone.

 

[Mr Blonde]

^ Exactly, and I think it is quite a big jump depending on the individual patient of course. I think that if hydrocodone were to be introduced again then it would have to be S4, meaning whatever combination it takes to reach that scheduling, and there would also have to be some sort of effort to change the opinions of the many doctors who would probably consider it a high risk substance.

 

[onlyone3232]

i got like a whole 50 box of dextropropoxyphene with apap whcih my oxy guy gave me. eveb though they're suppose to be as good as panadeine forte. they're not. just do cwe for otc opiate. not tramadol was a good drug. took it for 4.5 months straight. helped my depression alot...... now im doin h........ so who fuckin gives a shit about anything weaker now

 

[tyrael]

And tbh, are there any of us (at all, in any part of Australia? ) in any little way disappointed? Clearly no recreational value but even as a "mild+ analgesic" - better of taking paracetamol!

i got like a whole 50 box of dextropropoxyphene with apap whcih my oxy guy gave me. eveb though they're suppose to be as good as panadeine forte. they're not. just do cwe for otc opiate. not tramadol was a good drug. took it for 4.5 months straight. helped my depression alot...... now im doin h........ so who fuckin gives a shit about anything weaker now

And I wouldn't bother - especially with the amount of paracetamol you'd need to also ingest since (afaik) both chemicals have very similar water solubilises - no way for most people to extract it. As other's have attested there's no analgesic help let alone recreational! Also, although dextropropoxyphene is "technically" an opiate , it actually have other side effects which can (I guess in some) cause serious harm.


Edit:
(although I'm just going to list it's problems I'm sure who ever looks at this could google them)

- It has prominent anaesthetic properties (quite a bit more then a number of on the market, main stream anaesthetics)
- Due to have the above properties if one were to overdose Naloxon wont help!
- It effects basic sodium channels causing typically heart problems, anathema and the like ( RA, AH, HV and QRS internals!)
- And of course the usual problems which could go wrong when using strong opiates!

Tbh I reckon there's more but I can't remember!

 

[Charles Bronson]

Good...I fucking hate this drug. Almost killed me, I only took what the good doctor prescribed me..and my breathing dropped dramatically. Fucking shit