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The U.S. Food and Drug Administration ( FDA ) herald today ( June 8) that it has requested that Endo Pharmaceuticals , a drug company , removethe opioid painkillerOpana ER from the drug market .
This is the first clock time that the federal agency has bespeak that a drug companionship voluntarily hold on selling a medicine because of therisk of abusethat the drug carries , theFDA said in a program line . If the company does not choose to do so voluntarily , the FDA will force the publication by withdrawing its approval for the drug .
Opana ER
The request was made after the FDA determined that injecting the drug , which is one way of blackguard it , was linked to outbreaks of disease , including HIV and hepatitis C. [ America ’s Opioid - Use Epidemic : 5 Startling fact ]
" The vilification and manipulation of reformulated Opana ER by injection has lead in a serious disease outbreak , " Dr. Janet Woodcock , the director of the FDA ’s Center for Drug Evaluation and Research , said in a statement .
In March , an consultatory committee of independent experts voted 18 to eight that the benefits of the drug no longer outweighed its risks .
" When we determined that the product had grievous and unintended consequence , we made a decision to request its backdown from the market , " Woodcock said . " This action will protect the public from further potential for misuse and abuse of this production . "
Opana ER ( oxymorphone hydrochloride ) was first approved by the FDA in 2006 for use by people with temperate or severe continuing pain . The extended - release preparation of the medicament let for a continuous release of the drug into the physical structure .
The drug was reformulated in 2012 in an attempt to make the medication more difficult for people to blackguard ; specifically , the drug makers sought to make it difficult for users to take a hit or inject the drug . Although the reformulated drug was approve , the FDA later make up one’s mind that this modification did not " meaningfully boil down contumely . " The agency say that it would not allow the company to mark the drug with speech describe its potentially abuse - deter properties , the argument said .
An FDA review of available data on the drug launch that the means people abuse the medication had shift significantly after its reformulation , changing from snorting to injectant . The increment in injection of Opana ER has been linked to outbreak ofHIVandhepatitis C , two virus that can be transmitted through syringes . There have also been cases of a serious blood disorder called thrombotic microangiogpathy linked to the abuse of the drug .
The FDA has previously requested that company take away opioid painkillers from the market place ; however , in those cases it was not because of the risk of infection of insult that the drug carried . In 2010 , for example , theFDA recommendedthat drug companies bar sell the opioid pain reliever propoxyphene hydrochloride , but this was done because the agency determined that the drug was dangerous for heart health .
In add-on , the FDA said it will persist in to count at the hazard versus the benefit of all other opioid painkillers on the market and take further action mechanism if postulate .
" We are facingan opioid epidemic — a public wellness crisis , and we must take all necessary steps to reduce the scope of opioid misuse and abuse , " FDA commissioner Dr. Scott Gottlieb said in the statement . " We will continue to take regulative steps when we see situation where an opioid intersection ’s risks outweigh its benefits , not only for its intended patient universe but also in heed to its potential for misuse and abuse . "
Originally publish onLive Science .
