The U.S. Food and Drug Administration made headlines with its Thursday request that Endo Pharmaceuticals, an international drug manufacturing corporation, remove a prescription opioid painkiller from the market.
And for Dr. Vipul Kella, an emergency medicine physician at Frederick Memorial Hospital, the move was a good first step.
“I think there are other similar medications on the market that deserve to be pulled, and I hope it will set off a chain of similar reactions from the agency,” Kella said. “It’s a great first event.”
The targeted painkiller was Opana ER, or oxymorphone hydrochloride — an opioid-based, extended-release tablet first released on the market in 2006.
In 2011, Endo released a reformulated version of the medication designed to be more resistant to abuse by snorting or injecting, though it failed to meet FDA standards that would designate it as an “abuse-deterrent” product.
The reformulation efforts included chemical additions that supposedly made the pills harder to crush, and form a thick gel when exposed to liquid. But FDA officials still found that abuse of the drug was prevalent, said Sarah Peddicord, a press officer for the agency.
“You could still cut it, grind it, chew it up, manipulate it in other ways,” Peddicord said. “We also had a concern that it could readily be prepared for injection. The crushing abuse went down, but the IV abuse went up, and we saw some public health issues around the country.”
Thursday’s request was the first time that the FDA has taken steps to remove an opioid painkiller from sale based on widespread concern over the potential for abuse.
Abuse of Opana was also a significant issue for Frederick County residents. In May, a Hagerstown man was arrested in Frederick after police found unprescribed oxymorphone hydrochloride pills in his possession. In 2016, police shut down a prescription drug ring in Frederick that also involved the medication, often known by the street names “panda” or “pandabear.”
Beyond the criminal distribution of the drug, Kella said he’s witnessed too many patients come through the emergency room overdosing on Opana or other prescription opioids.
As an emergency room physician, Kella added, he rarely prescribed Opana precisely because of its potential for abuse. If patients need an opioid-based painkiller, they’re typically given only a two- or three-day supply and required to follow up with their regular doctor if they need a refill.
In other departments at FMH, and among private physicians, the drug was more commonly prescribed after cancer diagnoses and for the management of chronic pain. And despite efforts by Endo to change the formulation of the drug, Kella said, the risk of abuse outweighed its benefits.
“Based off what we’ve seen, with the extraordinary number of patients who were abusing Opana, it’s just not as effective as it should have been,” Kella said, referring to efforts to make the drug harder to abuse. “While there is a need for these sorts of medications in certain populations with certain conditions, the majority of what we’re seeing is that it’s abused by people who do not have these conditions at all.”
Nationally, Opana was also linked to several disease outbreaks by the Centers for Disease Control and Prevention. In 2012, there was an outbreak of an illness resembling thrombotic thrombocytopenic purpura (TTP) — a disease that causes clots to form in small blood vessels throughout the body — in northern Tennessee.
The outbreak was later linked to the injection of Opana ER.
In 2015, there was also an outbreak of HIV in Scott County, Indiana, that was also connected to patients injecting the drug.
Endo Pharmaceuticals responded to a request for an interview with a formal statement released after the FDA’s announcement. In the release, the company said that it is “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.”
“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,” the release later read. “Endo remains confident in the body of evidence ... demonstrating that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients.”
The request to withdraw Opana ER from the market did not include generic equivalents for the drug, Peddicord said. The agency is assessing available data on generic oxymorphone hydrochloride before deciding whether to pull those products from the market as well.
The agency is also working on developing further steps to help prevent opioid abuse, according to Peddicord. Most opioid-based painkillers are now generally required to undergo up to 11 different studies to determine how they’re being used. The FDA is also working to educate health care providers on prescribing opioids and emphasize the importance of abuse-deterrent drugs.
“These products aren’t abuse-proof — they can still be abused, especially by the oral route,” Peddicord said. “It’s not a perfect, fail-safe tool, but we do stress the technology because it’s one part of a larger process. If you do have properties that look like they’re effective at deterring abuse, then that’s a positive step.”