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The FDA asks manufacturers of the opioid analgesic Opana ER to pull the drug out of the market

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Friday, June 9, 2017 (HealthDay News)-Sales of represcribed Opana ER, a prescription opioid analgesic, should be stopped in the United States, the US Food and Drug Administration said.

With Endo Pharmaceuticals voluntarily requesting the withdrawal of the drug on Thursday, the FDA said the benefits of the drug could no longer outweigh the risk of abuse. This is the first time the FDA has started taking opioids. pain Drugs off the market due to the public health threat of abuse.

FDA analysis of data collected after the drug was approved showed that injection abuse of represcribed Opana ER (oxymorphone hydrochloride) was associated with a serious outbreak. HIV And Hepatitis C, And a case of a serious blood disorder called thrombotic microangiopathy.

In March 2017, the FDA Advisory Board concluded that the benefits of the represcribed Opana ER no longer outweigh the risks.

“We are facing an opioid epidemic. It is a public health crisis and we need to take all necessary steps to reduce the extent of opioid misuse and abuse,” said FDA Commissioner Dr. Scott Gottlieb. Said in the agency news release.

“If the risk of an opioid product outweighs its benefits, not only in the intended patient population, but also in the potential for misuse and abuse, we will continue to take regulatory action,” he added. ..

Addiction For prescription opioids Oxycodone (Oxycontin, Perco set)and Hydrocodone (Bicoprofen) Is spreading in the United States. According to health officials, the number of deaths from opioid overdose has quadrupled in the last 15 years.

Opana ER was first approved in 2006 for moderate to severe management. pain Patients who needed opioids for a long period of 24 hours. In 2012, Endo replaced the original Opana ER formulation with a new formulation aimed at making the drug resistant to physical and chemical manipulations for abuse by snorting and injecting. I did.

However, the FDA has concluded that represcribing cannot significantly reduce substance abuse.

“The abuse and manipulation of represcribed Opana ER by injection has resulted in the outbreak of serious illness. When we determine that the product has dangerous and unintended consequences, we have decided to demand withdrawal from the market. “The FDA’s Center for Drug Evaluation and Research said in a news release.

The FDA said it would withdraw drug approval if Endo did not voluntarily remove the represcribed Opana ER from the market.

Until Opana ER withdraws from the market, the FDA warns healthcare professionals and others about the serious risks associated with substance abuse.

“We are reviewing the requirements and assessing the full range of potential options,” Endo said in a statement.

–Robert Plate

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References

Source: US Food and Drug Administration, News Release, June 8, 2017

The FDA asks manufacturers of the opioid analgesic Opana ER to pull the drug out of the market

Source link The FDA asks manufacturers of the opioid analgesic Opana ER to pull the drug out of the market

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