A new version of Endo's pain medication known as Opana ER is responsible for an HIV outbreak in Southern Indiana. The sole reason for the outbreak that is associated with the drug is that the newer formulation is easier to prepare for purposes of intravenous injections, and that is lethal in the hands of a drug addict.
Injectable drugs amongst addicts are dangerous because the users tend to share needles. Shared needles make it easier for diseases that are spread through contaminated blood. Diseases like HIV and Hepatitis, spread like wild fire. One HIV positive person can quickly spread the disease by use of shared needles, and this is the case for the rural Indiana community.
Since the introduction of the drug in 2012, there have been 135 new HIV infections in Southern Indiana, a county of just 4200 People. The Center for Disease Control and Prevention warns that if the pandemic is left unchecked, the results could be more disastrous in the future because many addicts prefer the drug to the street heroin.
Although harder to crush than its predecessor, the FDA was initially adamant to approve the drug and warned against the dangers of releasing the pain reliever to the market after conducting a post-market test. Endo claimed that it withdrew the previous version of the drug because of safety and effectiveness reasons. The FDA’s argument claimed that the availability of the earlier version of the drug was controlled and only available to approved manufacturers.
The following are reasons why the FDA claimed that the drug should not be released to the market:
1) The newer formulation feature 'uncrushable' does not hold any water because it could still be subjected to manipulations such as chewing, cutting, grinding and finally swallowing or snorting.
2) The new Opana ER labeling is identical to the older version. It does not come with a warning for the general public that it's prone to abuse. Any drug that has the potential of being abused should come with a warning section, not just notifying the vendors and consumers.
Endo has continued to deny that the new formulation is responsible for the epidemic, putting the blame on generic medications. The county Sheriff Dan McClain has however dismissed Endo's claims. He says that he has concrete evidence that there is an enormous amount of the new formulation available for purchase on the streets.
Senator Joe Donnelly visited the area and is doing his best to push Congress to pass the Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act that failed to be passed by the committee in 2014. If adopted, the law could help curb the epidemic, which is spreading at an alarming rate.
The bill is intended to fund a program that would teach first responders on how to use Naloxone, a drug that is administered in cases of emergency overdoses. The bill also calls for tightening of the availability of the drug, as well as monitoring its use. The new act will make it harder for street peddlers to have access to this dangerous drug.