The U.S. Food and Drug Administration requested Thursday to pull Endo Pharmaceutical’s strong opioid painkiller off the market expressing worries about drug abuse.
“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 Scott Gottlieb said.
Drug overdose deaths have been on the rise in the U.S., with opioid overdoses accounting for more than 33,000 deaths in 2015, according to the U.S. Centers for Disease Control and Prevention. Nearly half of all such deaths involved a prescription drug, the state agency added.
|FDA requests Opana, a commonly abused opioid prescription drug, to be taken off the market.|
The FDA’s decision, made in an 18-8 vote by experts, is based on “a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.”
Endo’s Opana ER (compound: oxymorphone hydrochloride) is almost twice as potent as the opioid drug oxycontin. The FDA granted the drug approval in 2006 to manage “moderate-to-severe pain” that requires regular opioid use for an extended period.
Opioids increase dopamine levels in the brain to cause feelings of euphoria, which causes it to become an easy target of abuse due to their addictive nature. In 2015, CNN reported Opana became the choice of widespread substance abuse, which led to HIV and hepatitis C outbreaks, and some cases of a severe blood disorder called thrombotic microangiopathy.
The company, attempting to fight drug abuse, claimed to have reformulated the drug so that it could not be crushed or molded for snorting or injection. However, the company came under fire from both the FDA and the state of New York for not making significant changes that reduced the risk of abuse.
“The misuse and manipulation of reformulated Opana ER by injection have resulted in a severe disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from the further potential for misuse and abuse of this product.”
The company must now choose between voluntarily taking Opana off the market or face an impending formal FDA drug approval withdrawal. The FDA intends to continue issuing warnings and informing the public about the risks of Opana use in the meantime.
“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 regarding its potential for misuse and abuse,” Commissioner Gottlieb added.
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