FDA asks drug company Endo International to pull opioid painkiller from market for first time

For the first time, the FDA has asked a drug company to remove its opioid painkiller off the market.

The FDA requested on Thursday that Endo International take its extended-release opioid painkiller Opana ER (otherwise known as oxymorphone hydrochloride) off the market, after deciding that the drug's benefits no longer outweighed its risk for abuse.

The FDA rarely asks drugmakers to remove products from the market, and this is the first time it's asked for an opioid to be removed for a public health reason.

The move could signal a major shift in the way the FDA is confronting the opioid epidemic, potentially leading to more opioids getting requests for removal.

RELATED: What opioids do to your health

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What opioids do to your health

Opioid painkillers capitalize on our body's natural pain-relief system. We all have a series of naturally produced keys ("ligands") and keyholes ("receptors") that fit together to switch on our brain's natural reward system — it's the reason we feel good when we eat a good meal or have sex, for example. But opioids mimic the natural keys in our brain — yes, we all have natural opioids! When they click in, we can feel an overwhelming sense of euphoria.

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Opioid painkillers can have effects similar to heroin and morphine, especially when taken in ways other than prescribed by a doctor.

When prescription painkillers act on our brain's pleasure and reward centers, they can make us feel good. More importantly, though, they can work to reinforce behavior, which in some people can trigger a repeated desire to use.

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You may also feel sleepy.

Opioids act on multiple brain regions, but when they go to work in the locus ceruleus, a brain region involved in alertness, they can make us sleepy. Why? The drugs essentially put the brakes on the production of a chemical called norepinephrine, which plays a role in arousal.

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Your skin may feel flushed and warm.

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You'll begin to feel their effects 10 to 90 minutes after use, depending on whether they're taken as directed or used in more dangerous ways.

Some drugmakers design versions of their medications to deter abuse. Extended-release forms of oxycodone, for example, are designed to release slowly when taken as directed. But crushing, snorting, or injecting the drugs can hasten their effects.

It can also be deadly. Between 2000 and 2014, nearly half a million Americans died from overdoses involving opioid painkillers and heroin, a report from the US Centers for Disease Control and Prevention found. The most commonly prescribed painkillers were involved in more overdose deaths than any other type of the drug.

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Your breathing will slow as well.

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Depending on the method used, the effect can last anywhere from four to 12 hours.

For severe pain, doctors typically prescribe opioid painkillers like morphine for a period of four to 12 hours, according to the Mayo Clinic. Because of their risks, it's important to take prescription painkillers only according to your physician's specific instructions.

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Overdosing can stop breathing and cause brain damage, coma, or even death.

2014 report from the American Academy of Neurology estimates that more than 100,000 Americans have died from prescribed opioids since the late 1990s. Those at highest risk include people between 35 and 54, the report found, and deaths for this age group have exceeded deaths from firearms and car crashes.

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Combining them with alcohol or other drugs — even when taken according to the directions — can be especially deadly.

Since they slow breathing, combining opioid painkillers with other drugs with similar effects can drastically raise the chances of accidental overdose and death.

Yet they're often prescribed together anyway, according to the National Institute on Drug Abuse. "Unfortunately, too many patients are still co-prescribed opioid pain relievers and benzodiazepines [tranquilizers]," the institute said. In 2011, 31% of prescription opioid-related overdose deaths involved these drugs.

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Abusing opioid painkillers has been linked with abusing similar drugs, like heroin.

A CDC report found that people who'd abused opioid painkillers were 40 times as likely to abuse heroin compared with people who'd never abused them. The National Institute on Drug Abuse says that close to half of young people surveyed in three recent studies who'd injected heroin said they'd abused prescription painkillers before they started using heroin.

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You may also develop a tolerance for the drugs so that you need more to get the same effect over time.

Tolerance to opioid painkillers happens when the brain cells with opioid receptors — the keyholes where the opioids fit — become less responsive to the opioid stimulation over time. Scientists think that this may play a powerful role in addiction.

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Suddenly stopping the drugs can result in withdrawal symptoms like shakiness, vomiting, and diarrhea.

Taking prescription painkillers for an extended period increases the likelihood that your brain will adapt to them by making less of its own natural opioids. So when you stop taking the drugs, you can feel pretty miserable. For most people, this is uncomfortable but temporary.

But in people who are vulnerable to addiction, it can be dangerous because it can spurn repeated use.

"From a clinical standpoint, opioid withdrawal is one of the most powerful factors driving opioid dependence and addictive behaviors," Yale psychiatrists Thomas Kosten and Tony George write in a 2002 paper in the Journal of Addiction Science & Clinical Practice.

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"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 in a news release.

More than 183,000 people died from overdoses related to prescription opioid painkillers like oxycodone, hydrocodone, fentanyl, and morphine over the last 15+ years.

Endo's stock was down more than 14% after-hours on Thursday on the news.

When Opana ER is taken properly orally, it slowly releases into the body as intended. But if the drug is snorted or injected, it releases its dose all at once.

In 2012, Endo reformulated Opana to have abuse-deterrent properties. The new formula turned the pill into a gel that supposedly made it hard to snort or inject when crushed. But in 2013, the FDA found Opana was still easy to inject or snort despite the new formulation.

The abuse-deterrent formulation of the drug was likely tied to an HIV outbreak in Indiana in 2015 that resulted in 165 cases of the disease. The CDC interviewed 112 of the people who contracted HIV, finding that 96% of them had injected Opana using shared needles.

By far the most common route of abuse, however, is ingestion, either by taking too many pills at once or crushing it to counter the timed-release properties. No abuse deterrence properties can stop that.

The FDA held an advisory committee hearing in March to discuss whether the drug's benefits for pain still outweigh its risks. The panel voted that they did not.

In a release, Endo said it was reviewing the FDA's request and stood up for its drug — when used as intended.

"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 company said.

If Endo doesn't remove the drug from the market voluntarily, then the FDA can formally withdraw its approval.

The request to the drugmaker came just one month after the Senate confirmed Gottlieb as FDA commissioner, and it could be a signal of what to expect from the agency's response to the opioid epidemic under his leadership. The FDA is one of many government agencies that play a critical role in public health and drug abuse.

"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," Gottlieb said in a release.

That leaves the door open for the FDA to take this kind of action for other prescription painkillers that have been approved but are frequently misused.

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