FDA Wants To Withdraw This Opioid Drug From The Market
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The Food and Drug Administration (FDA) wants to withdraw the opioid drug known as Opana ER painkiller from the market. They are concerned about this drug that is too easily abused.
FDA asked the Endo Pharmaceuticals about its withdrawal from the market. The drug maker stated that it will review the request and is now evaluating the full range of potential options.
Scott Gottlieb, the FDA Commissioner, said that they are facing an opioid epidemic -- a public health crisis and they must take all necessary steps to lessen the scope of opioid misuse and abuse.
The said drug was approved in 2006. On the other hand, it became harmful as it was blamed for inciting an HIV outbreak in rural Indiana in 2015. It was also reported that the drug causes serious blood diseases that could lead to organ damage, according to PBS.
Opana ER is intended to ease the moderate-to-severe pain for patients for whom alternative options are ineffective. It is reported that there are some increased risks of addiction and overdose. With this, the doctors are given instruction to prescribe the said drug. On the other hand, it was found that injecting the drug has been linked to a serious outbreak of HIV and hepatitis C and serious blood disorder, according to Time.
Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, stated that when they determined that the drug had dangerous unintended consequences, they decided to request its withdrawal from the market. She further said that this action will protect the public from a further potential for misuse and abuse of this drug.
Meanwhile, Dr. Gottlieb also said that they will continue to take regulatory steps when they see situations where an opioid product's risks outweigh its benefits. In case Endo will not withdraw the Opana ER from the market, the FDA will formally withdraw approval. It will also continue to evaluate and examine all approved opioid pain medicines.