The U.S. Food and Drug Administration has requested the removal of Endo Pharmaceuticals' opioid pain medication from the market, marking one of the first times the agency has tried to get an opioid pain medication off the market because of the public health consequences of abuse.
The FDA's reasoning was simple: the risks of the medication Opana ER outweigh the benefits, the agency said Thursday in a statement.
"We are facing an opioid epidemic–a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse," FDA Commissioner Dr. Scott Gottlieb said in a statement. "We will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse."
The newly appointed commissioner said his highest initial priority is to take immediate steps to curb the opioid epidemic that has claimed countless lives throughout the nation. He has recommended new FDA policy that requires mandatory education on opioid abuse for healthcare professionals, limiting the number of doses a patient can be prescribed, and giving more scrutiny to new opioid drugs during their review.
Opana ER was reformulated in 2012 to make it harder to crush, ideally reducing abuse through snorting the painkiller. But many users dissolved and injected the drug, which has led to an outbreak of HIV and hepatitis C, according to the FDA.
"When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
The agency said it would take formal action to remove the product from market if Endo Pharmaceuticals denies the FDA's request. In the meantime, the FDA is making healthcare professionals aware of the risks associated with the powerful painkiller.
It will continue to review the risks and benefits of other similar drugs, the agency said.
