Thursday, October 02, 2008

New Version of Oxycontin Sparks Debate

Recently, a new version of the "Hillbilly Heroin" or Oxycontin was presented to the FDA for evaluation. It is said to feature a plastic-like coating that fuses to the tablet, making it harder to crush and turns into a gooey mess if abusers try to inject it.

“These are clearly difficult questions for which there are no easy answers,” Dr. Bob Rappaport, FDA's chief of painkilling drugs, wrote the advisory panel.

Back when Oxycontin was released in 1996, it was hailed as a miracle drug. That was until they discovered that it had a heroin-like effect if crushed, snorted or injected. Since then, there had been a growing number of cases on Oxycontin abuse and addiction as well as deaths.

According to the maker, Purdue Pharma, if someone tries to crush it, the plastic-like coating makes the tablet more likely to break into large fragments instead of a powder, the Stamford, Conn.-based company wrote. The coating renders the drug “a gelatinous mess” when mixed with alcohol or other solvents in attempts to dissolve and inject it, the documents say.

But the FDA cited concerns, including:

Some people who died from OxyContin abuse swallowed the drug without crushing it. Would the new version mislead doctors or patients into thinking OxyContin is less risky than it really is?

Lower doses are set to be reformulated initially, with higher doses converted in the future. Does that increase risk from the higher doses in the meantime?

Moreover, “there is no perfect formulation that can resist all forms of tampering,” FDA's Rappaport wrote. If approved, the new version's label “would have to be carefully crafted so as to avoid the publication of a road map describing how to defeat these changes.”

Hopefully, this new version won't make it into the market. You see, there are no guarantees plus the fact that the formulation is the same, meaning, it will still have the same heroin-like effect once abusers find a way to get around this version.


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