Pharma & Healthcare Monitor Worldwide
July 10, 2017
Weeks after the U.S. Food and Drug Administration (FDA) said opioid painkiller Opana ER should be removed from the market amid concerns about the potential for abuse, Endo Pharmaceuticals has agreed to pull the drug, which has been linked to serious outbreaks of HIV and hepatitis C.
Endo maintains that it continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride) when used as intended. But the company says it decided to voluntarily remove the drug from the market after careful consideration and consultation with the FDA.
Although Endo had reformulated Opana with the intention of making it more difficult to abuse, the FDA said last month that it had determined that this change ultimately resulted in a significant shift in the route of abuse of Opana ER from nasal to injection.
Oxymorphone hydrochloride has a short half-life, which means that the desired high is gone sooner than with other opioids. Thatís caused some who abuse Opana ER to inject the drug more frequently.
The FDA was also able to link the shift from inhaling Opana to injecting it with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy, a dangerous blood disorder.
Opana was linked to the 2015 HIV outbreak in the rural Indiana community of Austin that resulted in dozens of confirmed HIV cases in a town of only around 4,000 people. The outbreak was so severe that then-Governor Mike Pence declared a public health emergency, creating a temporary exception to the stateís ban on needle exchange programs. Though Pence had openly opposed needle exchanges, he eventually signed a new law that allows for their use in similar emergencies.
Going forward, Endo says it plans to work with the FDA to coordinate Opanaís exit from the market in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals.
Although Endo has agreed to withdraw the drug from the market, the company stresses that itís still standing by Opana ER.
Endo remains confident in the clinical research and other data demonstrating Opana ERís safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients, the company noted.
Original headline: Endo Pharmaceuticals Agrees to Remove Opioid Painkiller Linked to HIV Outbreak From The Market
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