FDA GOING TOO FAR WITH REMOVAL OF OPANA ER

in fda •  7 years ago 

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Removing an opioid due to abuse is absurd, especially while citing claims of a Hep C & HIV epidemic which is a problem with access to clean needles, a problem Mike Pence chose to ignore and instrad blame a drug. Removing Opana ER is not going to change anything, and it's not even the 1st, 2nd or 3rd most abused opioid. If the FDA wanted to slow abuse the would be removing OxyContin, however the lobbyist for Purdue Pharmaceuticals obviously contribute more to lobbying firms.

The only effects of rescheduling hydrocodone to a CII was to push those abusing it to heroin, and punish the legitimate patients with monthly doctor visits. Now the removal of Opana ER will push some illicit users to illegal street drugs, while others move to another rx opioid; however the patients, some of whom have tried everything, will again suffer. Patients taking Opana ER did not start it right off the bat, but rotated to it- first trying hydrocodone/APAP with inadequate relief, then onto MS Contin, after that failed to work or caused intolerable side effects they tried OxyContin and if that too failed a doctor may try Opana ER, however in my experience one might try fentanyl patches and even methadone before oxymorphone. The fact that ENDP reformulated the drug in 2012 because of pressure from the FDA and now the FDA is blaming the abuse-deterrent formula on thrombotic events is not the fault of the company but that of the illicit users. The FDA should include stronger warnings against IV use of Opana ER, or even a public service announcement. All opioids can be abused fentanyl patches are being smoked and injected, OxyContin is being ground down and snorted, Dilaudid pills are being injected, however we can't just remove all opioids from the market. We cannot and more importantly should not let the bad actions of the few hurt some of the most vulnerable in our society. We all must ask ourselves where do we draw the line?
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They should shift focus on street drugs.