The Food and Drug Administration might ask more pharmaceutical companies to pull their opioid products from the market.
“We must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Scott Gottlieb, M.D., said last week.
A request to Endo Pharmaceutical to pull its Opana ER, the first of its kind, reflected the opioid epidemic as a “public health crisis,” the FDA commissioner said. The medication has been tied to outbreaks of viral infections that include HIV.
It is unclear whether Endo will comply with the FDA request. In its response, Endo stated it “feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products.”
“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. 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.”
Other opioids being considered for ouster by the FDA: oxymorphone extended release and oxymorphone immediate release, according to Bloomberg BNA.
If Endo declines to remove the drug, the FDA could hold a hearing to discuss whether it should be removed. If the FDA withdraws its approval after the hearing, Endo could sue. However, consumer advocates said that if Endo doesn’t remove it from the market, those who are injured or killed could claim product liability.
