The FDA has asked Endo Pharmaceuticals to pull its opioid pain medication, Opana ER (oxymorphone hydrochloride), from the market amid concerns that the drug’s benefits do not outweigh the potential risk of abuse. The move is a sign that efforts to combat the opioid epidemic in the US are heating up, prompting the regulator to take the unprecedented step of removing a drug from market due to its addiction potential.
“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,” said Dr. Scott Gottlieb, the new commissioner of the FDA. “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 FDA cites postmarketing data in its decision which found that the instance of injection abuse, over inhalation abuse, of the extended release opioid increased after Endo reformulated Opana ER. This abuse has been linked to an outbreak of HIV and hepatitis C, and people injecting the drug face a higher risk of blood clots forming in small blood vessels: a condition known as thrombotic microangiopathy.
For their part, Endo’s response to the FDA’s request was respectful, however they also reaffirmed their belief in the safety of the opioid. Endo is compelled to voluntarily remove the product from market, however the FDA has the power to take additional action if the company fails to take the necessary steps.
“Despite the FDA’s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed,” said a press release issued by Endo. “Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”
The FDA’s Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees reviewed the postmarketing data on Opana ER back in March to determine whether the opioid analgesic should remain on the market. They voted 18 to eight, with one abstention, that the benefits of the reformulated drug no longer outweighed its risks to public health.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”