NEWS: Deadly pain-relief drug recalled

[Conan Troutman]

Deadly pain-relief drug recalled

August 11, 2007 11:32am

Article from: AAP

TWO people are dead and two others have undergone liver transplants from a drug, used by 60,000 people in Australia, which was urgently recalled today by the Federal Government.

The Therapeutic Goods Administration (TGA) said patients prescribed the drug Prexige, used to treat osteoarthritis, should stop taking the medication immediately and seek medical advice to get an alternative prescription.

Prexige was first approved by the TGA in 2004, but has only gained widespread use since being listed on the Pharmaceutical Benefits Scheme last year.

Novartis Pharmaceuticals produces the drug, which is listed under the technical name Lumiracoxib.

Approximately 60,000 people take Lumiracoxib in Australia, which is prescribed for relief of osteoarthritis, post-operative pain, pain related to dental procedures and painful menstruation.

The TGA has received reports of eight people taking the drug who suffered serious liver reactions, including two deaths and two liver transplants.

"The TGA has taken this advice to cancel the registration of Lumiracoxib in order to prevent further cases of severe liver damage," TGA medical adviser Rohan Hammett said.

"It seems that the longer people are on the medicine, the greater chance of liver injury."

People with inquiries about the withdrawal of Prexige can ring the TGA info line on 1800 004 599 or Novartis Pharmaceuticals on 1800 671 203.

SOURCE

[Torsten]

it takes 8 people to suffer [over several months] before the TGA decides on URGENT action? Fucking drama queens.

[teonanacatl]

8/60000+?

[Auxin]

8 is just the ones that were reported, the vast majority of prescription side effects events are never reported. Estimates range from 90% to 99% being unreported. Hundreds probably got side effects, tho the death toll was probably low.

[SirLSD]

eh, placebo has a huge list of side effects too.

as for side effect events going unreported: yes lots are. not everyone that gets nausea, diarrhea, stomach upset, headache, etc from a prescription medication bothers reporting it. though im sure all those that require organ transplants do. so 4/60000, is 1 in 15 000. so they would have needed to find 15000 test subjects to undergo treatment for the clinical trials before this problem would have been observable. if we needed 15 000 test subjects for each clinical trial then we would have hundreds less life saving medications available to us. that is why if everything goes well in a trial, they monitor its use and do reviews to make sure it is still safe.

why wait for 2 deaths and 2 serious organ failures? well if they withdrew every medication that resulted in 1 death then there would be no medications left. paracetamol and aspirin kill many people every year. drinking too much water has resulted in many deaths too. not to mention hot dog eating contests. a few people have died from hotdogs.

there is risks in everything in life. its just a matter of determining the risk versus benifit ratio and making a decision.

though accidents will happen. unforseen events will occur.

but there are those that will bash the pharmaceutical companies every chance the get, even while inhaling their ventolin.

[MORG]

a few people have died from hotdogs.

[shuts eyes, bows and shakes head solemnly]

Rest in peace. A tragic waste of some of the world's best and brightest.

[dqd]

It's ok, there'll be more hotdogs

[Torsten]

but there are those that will bash the pharmaceutical companies every chance the get, even while inhaling their ventolin.

wasn't having a go at the TGA for allowing this on the market or for taking it off. My beef is with the way they act. How can something be urgent and so dramatic if people have already had transplants, died or recovered. Do they have a magic number like 1 in 15,000 where they suddenly wake up and go 'well, yesterday we had no idea, but today it is our top priority'. I mean, either these fat cats are asleep at the wheel or they are dramaqueens.

Personally i agree with you that 1 in 15,000 isn't anything even terribly newsworthy [ever looked at the stats for paracetamol?], hence I suspect the drama serves a political or financial purpose. I wonder what new drug is waiting in the wings to take over the terrified market and which TGA sidekick has friends on the boards of that company?!

[oxydiser]

Prior to about two months ago prexige was available in 200mg and 400mg tablets, one day novartis turned around and said they were discontinuing these strengths as they found 100mg had similar efficacy with less side effects - it smelled too much like they were trying to cover their asses in the wake of the COX-2 / heart attack scare that happened with vioxx, so it was suprising that this was not the cause of the recall. Alas the folks who died and had shot livers were taking the 200 and 400mg doses.

The lag in this information coming to light I think owes itself to the nature of post-marketing surveillance, that this liver damage appears to be a long term cumulative effect, which echos what SirLSD has said. While the TGA has had its eye on prexige for a while, I also think this is a beat up - I mean it hasn't been recalled in any other countries where is has been approved for longer and presumably used by a lot more people. You have to remember that the majority of people that take prexige IME are old with multiple medical conditions and medications, something that the TGA would have taken into consideration.

I wonder what new drug is waiting in the wings to take over the terrified market and which TGA sidekick has friends on the boards of that company?!

Did someone say drama queen? I think maybe it was a public service announcement more than anything