FDA Warned Opana Drugmaker of Dangers for Abusers

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FDA warned drugmaker about dangers of pain pill injection —a newer version of painkiller Opana. This new form of a pain killer could be driving addicts to inject the drug leading to the spread of HIV.

Officials in Indiana scramble to contain a fast-spreading HIV outbreak. Government officials warned one company that the newest version of a drug could be driving behavior contributing to this crisis. May 2013: FDA told Endo Pharmaceuticals (maker of widely used prescription pain pill Opana) that a new form of the medication could be driving addicts to inject the drug creating the spread of HIV.

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HIV outbreak in southern Indiana has created 8 more cases in January to 166 as of June. Resulted from addicts dissolving and injecting Opana according to the CDC. 96% of those who tested positive for HIV and interviewed by the CDC were injecting Opana.

Endo introduced a new version of the drug in 2012 and claimed it was designed to be abuse deterrent.

Previous versions of the drug could easily be crushed and snorted or dissolved and injected. Newer version had a special coating that supposedly made doing so more difficult

Endo removed the previous version from the market and asked FDA to rule it as unsafe. This ruling would’ve prevented other drug makers from introducing generic versions of the pill.

FDA denied Endo’s request rejecting company’s claims about new coating ability to deter abuse.

Even though new formulation was supposedly harder to crush, FDA found it may be easier to inject it.

Officials in Indiana’s Scott County said abusers discovered they could cook down the abuse deterrent version of the pill, dissolving it and preparing it for injection.

Addicts preferred the drug to heroin even though it is more expensive and the high doesn’t last as long. As a result, HIV was transmitted by sharing each others needles sometimes as often as 20x per day.

Endo Pharma:

  • Pennsylvania based company
  • Specializes in pain medications
  • Earned $1.6 billion in revenue from Opana from 2008-2012
  • Company has denied Opana is at the heart of the outbreak and has suggested various generic versions of its drug didn’t have the same abuse deterrent coating may be at fault

Endo held a conference in April with public health officials and stuck to their story. They denied repeated requests to be interviewed from reporters. The company claims they support a wide range of programs that provide awareness and education around appropriate used of pain medications.