FDA warns about serious blood disorder resulting from misuse of Opana ER

alasdairm

alasdairm

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FDA warns about serious blood disorder resulting from misuse of Opana ER
[10-11-2012] The U.S. Food and Drug Administration (FDA) recently became aware of cases of a serious blood disorder that occurred in individuals abusing the prescription pain medicine Opana ER (oxymorphone hydrochloride extended-release tablets) by injecting the drug into their bloodstream. This serious blood disorder, called thrombotic thrombocytopenic purpura (TTP), resulted in kidney failure requiring dialysis in some cases, and at least one death.

In TTP, blood clots form in small blood vessels throughout the body. The clots can limit or block blood flow to the body’s organs, such as the kidneys, brain, and heart. Certain blood cells called platelets help the blood to clot. In TTP, as platelets clump together in the blood clots, fewer platelets are available in the blood in other parts of the body to help with clotting there. This can lead to bleeding under the skin and purple-colored spots called purpura, or to bleeding inside the body. TTP can cause death or lead to other complications with permanent damage, such as kidney failure, brain damage, or stroke.

TTP appears to occur with Opana ER only when it is abused and injected intravenously. Opana ER is meant to be taken orally, and should only be taken when prescribed and as directed. Taking it any other way may result in serious adverse events, including death.
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alasdair
 
Is it possible that this was deliberate, that it was an intended facet of the reformulation?

The US government has a history of deliberately poisoning drug users. Two examples are Tylenol in opioids and methanol in industrial ethanol (especially during prohibition).

So it wouldn't be surprising if this were intentional.
 
I agree, they add stuff that is harmful if misused on purpose or as a direct result of their foolish belief that it will cut back on abuse. All it does is put people who abuse them in danger. Users are not simply going to stop because something is made harmful or harder to use. They will simply come up with a way they deem safe that works.

They need to either make pills abuse proof that have absolutely no bad effects if someone fucks around or admit that they are trying to harm users in an effort to scare them. Either way this "stopping junkies" needs to stop. People will never stop abusing opiates. You can't undo something that has been discovered and you can't get rid of an ancient and naturally produced class of drugs.
 
Yeah I wouldn't be surprised at all if this was intentional.

I wonder what part of the "abuse-proofing" system causes it? Could it be prevented by the user if they filtered it properly, or through some other technique?
 
I really don't blame the FDA. The job of the FDA is to keep the nations food and drugs safe, regulated, and consistent. The rampant abuse of Opana ER was certainly making the drug unsafe, thus it was necessary to reformulate it. Did they design the reformulation to make users extremely ill? Doubtful. It is most likely a side effect of the products. I am sure some conjecture could be drawn from the chemicals used, typical illicit preparation methods, and ROA, but I doubt any company is going to go out of their way to make a product easier or safer to misuse, whether pharmaceutical or industrial.
The FDA can only work inside the current paradigm of drug prohibition and they are beholden to the Executive Branch and must enforce laws passed by the Judiciary. They are not trying to kill drug users - I am sure many people inside the FDA are sympathetic to the issues created by drug prohibition, but this needs to be an entire paradigm shift, not just a reform or change of the FDA.
 
muvolution said:
I really don't blame the FDA. The job of the FDA is to keep the nations food and drugs safe, regulated, and consistent. The rampant abuse of Opana ER was certainly making the drug unsafe, thus it was necessary to reformulate it. Did they design the reformulation to make users extremely ill? Doubtful. It is most likely a side effect of the products. I am sure some conjecture could be drawn from the chemicals used, typical illicit preparation methods, and ROA, but I doubt any company is going to go out of their way to make a product easier or safer to misuse, whether pharmaceutical or industrial.
The FDA can only work inside the current paradigm of drug prohibition and they are beholden to the Executive Branch and must enforce laws passed by the Judiciary. They are not trying to kill drug users - I am sure many people inside the FDA are sympathetic to the issues created by drug prohibition, but this needs to be an entire paradigm shift, not just a reform or change of the FDA.
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I am not so optimistic
 
muvolution said:
I really don't blame the FDA. The job of the FDA is to keep the nations food and drugs safe, regulated, and consistent. The rampant abuse of Opana ER was certainly making the drug unsafe, thus it was necessary to reformulate it. Did they design the reformulation to make users extremely ill? Doubtful. It is most likely a side effect of the products. I am sure some conjecture could be drawn from the chemicals used, typical illicit preparation methods, and ROA, but I doubt any company is going to go out of their way to make a product easier or safer to misuse, whether pharmaceutical or industrial.
The FDA can only work inside the current paradigm of drug prohibition and they are beholden to the Executive Branch and must enforce laws passed by the Judiciary. They are not trying to kill drug users - I am sure many people inside the FDA are sympathetic to the issues created by drug prohibition, but this needs to be an entire paradigm shift, not just a reform or change of the FDA.
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The FDA is a bureaucratic joke, though. Remember, this is the same FDA that classified walnuts as drugs because they claimed health benefits of fatty acids.

"Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)]. Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application. Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded under section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]."

http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm
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The FDA is a bureaucratic mess just like the rest of our country. The reason that anyone has any interest in making the drugs abuse proof is not to actually curb any misuse, but to provide Pharma the opportunity to create new patents.
 
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