Palladone has been pulled from the market
Filed in archive News on July 23, 2005
Palladone, which is extended-release hydromorphone, has been pulled off the market, due to "new data". Shouldn't this have been addressed before the drug was introduced just 5 months ago?
According to the FDA news release, "Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol the extended release mechanism is harmed which can lead to dose-dumping."
Dose-dumping, the FDA says, is the rapid release of the drug's active ingredient into the bloodstream. The agency's news release says dose-dumping, even with a low dose of Palladone (12 milligrams), could lead to "serious, or even fatal, adverse events in some patients."
The FDA warns that the risk increases for higher doses of Palladone.
Symptoms of a hydromorphone overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, confusion, coma, tiredness, cold and clammy hands, and small pupils.
The FDA says Purdue Pharma has greed to suspend the sale of Palladone in the U.S. until the company discusses safety issues with the agency.
(Hitti, "Palladone Pain Drug Pulled Off the Market", WebMD, Jul.14)
Dose-dumping, the FDA says, is the rapid release of the drug's active ingredient into the bloodstream. The agency's news release says dose-dumping, even with a low dose of Palladone (12 milligrams), could lead to "serious, or even fatal, adverse events in some patients."
The FDA warns that the risk increases for higher doses of Palladone.
Symptoms of a hydromorphone overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness, confusion, coma, tiredness, cold and clammy hands, and small pupils.
The FDA says Purdue Pharma has greed to suspend the sale of Palladone in the U.S. until the company discusses safety issues with the agency.
Permalink: Palladone has been pulled from the market
Tags: pain palladone
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Rating: 6.50 out of 4 vote(s) cast.
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Response from:
Mitchell
(11/13/06 2:54am)
that picture is not palladone, it is suboxone
Response from:
drug treatment
(06/25/07 2:08am)
You don't say, i wonder why? I think the system is to blame in all this.
Response from:
Obi
(01/12/08 7:27am)
Because of some places using a picture of Suboxone along with this news story, some people have gotten the mistaken impression that Suboxone is being pulled off the market.
Response from:
Beau
(10/06/09 6:48pm)
I think they ought to put palladone on the market we need more diversity and choices of pain pills made available to those who need it,espescially terminally ill and cancer patients. I've taken hydromorphone before for pain and experienced a dramatic decrease in pain that i was going through(i got in a motorcycle accident). And basically I know that doctors like to rotate people off one painkiller to another due to the tolerance you build for whatever opiate your taking. So when you start taking a new or different painkiller you don't have the same tolerance and breakthrough pain management can be established by using this method. Thats why i would like to see palladone put back on the market we should have as many choices that are possible and i don't see palladone being anymore dangerous than Opana(oxymorphone), espescially since Opana is a stronger painkiller then Palladone.
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