Tag: opioids

Naloxone nasal spray may soon be in your pharmacy. Our medical analyst explains what it is and who can use it | CNN

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CNN
 — 

Two advisory committees to the US Food and Drug Administration have voted unanimously to recommend that a nasal spray version of the opioid overdose antidote, naloxone (also called Narcan), be made available over the counter.

If the FDA agrees with this recommendation, naloxone may soon be sold without a prescription in pharmacies and made available in grocery stores, big-box stores, gas stations, and corner stores around the country.

This development comes at a time when opioid overdoses are at a record high, rising more than 15% in one year. Deaths attributed to opioids rose from around 70,000 in 2020 to 80,800 in 2021, according to the US Centers for Disease Control and Prevention. The highly potent and lethal opioid, fentanyl, is implicated in the majority of these deaths.

What is naloxone, and how does it work to save lives from opioid overdose? How do you know if someone is overdosing, and how can bystanders administer the antidote? How can people get access to it now, and what will it mean if the FDA approves it for over-the-counter use? What more needs to be done to reduce overdose deaths?

To guide us through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also the chair of the advisory board for Behavioral Health Group, a network of outpatient opioid treatment and recovery centers around the United States. Previously, she was Baltimore’s health commissioner, where she led the city’s overdose prevention strategy.

CNN: How does naloxone work to save people overdosing on opioids?

Dr. Leana Wen: Naloxone is a medicine that rapidly reverses the effect of an opioid overdose. It is an antagonist to opioids, meaning that it attaches to the opioid receptors in the brain, and in doing so, reverses and blocks the effects of opioids.

Someone who has taken too large of a quantity of opioids can become unconscious and stop breathing. This is deadly — a person can die within minutes after they stop breathing. Naloxone reverses the effect of the opioid overdose and can restore normal breathing within a couple of minutes.

CNN: What are the different versions of naloxone? Does it work against illicit drugs like heroin and fentanyl as well as prescription drugs?

Wen: Naloxone comes in two main forms. There is the nasal spray version, with one manufacturer calling its product Narcan Nasal Spray. This version is sprayed into the nostril, similar to some allergy medications.

Naloxone also comes as a liquid. This form can be injected either intravenously through an IV, if a patient already has an IV inserted, or intramuscularly, usually as a shot through the quadriceps muscle in the leg.

Several years ago, there was another version of naloxone that was in an autoinjector, similar to an EpiPen that’s given to people with life-threatening allergic reactions. In 2019, the manufacturer made a business decision to stop making that version available to the public. (An autoinjector is still approved for use by the military and for chemical incident responders.)

The nasal spray, intravenous and intramuscular versions all work very well, and they all work against various versions of opioids. That includes not only heroin and fentanyl but also common opioid medications like oxycodone, hydrocodone, codeine and morphine. It’s important to note that one dose may not be enough, depending on how potent and how much opioid was taken. Often, several doses are needed to revive someone.

CNN: How do you know if someone is overdosing, and how can bystanders administer the antidote?

Wen: Signs of overdose include being unable to be awakened, breathing slowly or not breathing at all, and fingernails and lips taking on a blue or purple color while the skin becomes pale and clammy to the touch. Their pupils are often described as “pinpoint,” or very small.

Someone can overdose from taking too much of an opioid by accident. This often happens when fentanyl, an extremely potent opioid, is mixed with whatever the person is taking without their knowledge. Also, if an opioid is mixed with alcohol or benzodiazepines or other opioids, they can also become unresponsive. And there are instances when someone may not realize they are taking opioids, but the pill they obtained is contaminated with fentanyl.

If someone is overdosing, you or someone who is with you must call 911 immediately. In the meantime, administer naloxone. Naloxone reverses an overdose for up to about 90 minutes, but opioids can stay in the system for longer, so it’s still important for the person to receive medical attention after receiving the drug. Depending on the opioid the person took, they may need to be monitored in the hospital for hours after in case naloxone wears off while the opioid continues to have an effect.

If you have the nasal spray version, insert the tip of the device into the nostril and squeeze. Another spray may be given in the other nostril in two to three minutes if the patient remains unresponsive, and another one in another two to three minutes until either the patient responds or emergency help arrives. If you are trained to perform CPR, and the person isn’t breathing, you should administer CPR as well, in between giving naloxone.

CNN: Is naloxone safe to use? What if you’re not sure if someone is overdosing from opioids?

Wen: Yes, naloxone is extremely safe. If someone is not on opioids and is unresponsive, say, because they drank too much alcohol or has had a stroke, naloxone will have no adverse effect for them. That’s why emergency medical personnel routinely administer naloxone to patients who are found to be unresponsive; there is no harm to people who are unresponsive from non-opioid-related reasons.

If someone overdosed on opioids, naloxone reversal will send them into withdrawal. This could be unpleasant for the individual and could lead to vomiting, agitation, shivering, tearing up and having a runny nose. These aren’t desirable side effects, of course, but in cases when naloxone must be given, the alternative is death.

CNN: How can people get access to naloxone now? What will it mean if the FDA approves it for over-the-counter use?

Wen: As an emergency physician, I’ve given naloxone many times. First responders like paramedics and emergency medical technicians also routinely administer naloxone. When I served as Baltimore’s health commissioner, I felt strongly that everyone should be able to save someone else’s life.

Nonmedical personnel may already obtain and carry naloxone with them, but specific requirements and regulations vary by the state. Health departments and some community nonprofit groups have low-priced or free naloxone that they distribute to community members. Often, the naloxone is distributed to individuals who use drugs, because they are most likely to be around others who are overdosing. Also, their family members can use naloxone to revive them.

If the FDA approves the nasal spray naloxone for over-the-counter use, that means it will be more accessible. People should be able to purchase the spray from pharmacies, grocery stores, gas stations and perhaps even vending machines.

The problem is cost. We don’t yet know how the over-the-counter naloxone spray will be priced, and whether and how much insurance companies cover it will probably vary.

CNN: What more needs to be done to reduce overdose deaths?

Wen: Naloxone access is an important step. Someone who is overdosing has no chance for a better tomorrow if they are dead today. I would encourage everyone with a family member who is on opioids for chronic pain or has an opioid addiction to carry naloxone with them, so that they could save their loved one’s life.

Longer-term, a person who has an opioid use disorder needs treatment with a combination of medications and psychosocial supports. Much more needs to be done to expand treatment access, as well as to reduce the supply of illicitly manufactured drugs like fentanyl that are worsening the overdose crisis.

Finally, I want to remind everyone of 988, a new 24/7 phone and chat hotline that provides suicide counseling, crisis supports and referral for people in need of mental health and addiction support.

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Fentanyl Test Strips Are Saving Lives, but They’re Just the Start

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Feb. 15, 2023 — In December, Texas Gov. Greg Abbott did an about-face on an issue that has been a flash point in the debate over decriminalization of drug paraphernalia: the use of test strips that can detect fentanyl, the synthetic opioid. Abbott had previously opposed legislation legalizing the test strips, but he cited a stunning 89% increase in fentanyl deaths in Texas the prior year. 

“It’s an extraordinarily deadly problem,” Abbott said in a press conference where he explained his change of heart.

More than 100,000 people died of drug overdoses in the United States from September 2021 to September 2022, according to the CDC. Almost 70% of those were from fentanyl and other synthetic opioids. Now, the death toll is causing lawmakers across the country to change their tune.

A Policy Shift

Fentanyl test strips were developed in 2011 to test for the drug in urine by law enforcement, for parents wanting to know what their kids were taking, and for users wanting to know what was in the drugs they previously took. A Johns Hopkins University study in 2018 found that the strips could accurately detect fentanyl in drug residue. Soon after, California and Oregon were among the first states to provide their public health departments with free strips to distribute at needle exchanges.

The strips are simple to use and effective. When dipped in water that contains dissolved drug residue, the strips indicate immediately whether trace elements are contained in a substance, such as heroin, cocaine, or ecstasy. As little as 2 milligrams of fentanyl can be deadly depending on a person’s weight, tolerance, and past usage. 

States across the country have been legalizing fentanyl strips in the hopes of saving lives. Georgia passed a bill in July. Alabama, Tennessee, Pennsylvania, Wisconsin, South Carolina, and New Mexico all did the same. A similar bill has been introduced in Florida’s legislature. These states join some 30 others that have decriminalized the strips and made them available to drug users.

When the strips first came on the scene, they were used to remove fentanyl entirely from the drug supply. But today that’s not as true as it once was because fentanyl is now so prevalent, says Aaron Ferguson of Austin, TX, who advocates for safer drug use through the Urban Survivors Union. The organization hands out strips to people who are thought to be more likely to use some type of precaution to prevent against fentanyl overdose. For example, he recently distributed the strips and naloxone, a medication commonly used to reverse opioid overdoses, to a mother who knew her son was using opioids and wanted him to be safe.  

A Poisoned Supply

“We’re in a drug poisoning crisis,” says Jacqueline Goldman, a research assistant at the Brown University School of Public Health. The crisis has deepened not necessarily because more people are using drugs, Goldman says, but rather “more people are dying from them because they’re so potent.”

Compared to other Western countries, the United States has always had a “puritanical” view of harm reduction strategies to cope with drug use and abuse, says John McIlveen, PhD, the top opioid treatment official for the Oregon Health Authority. “Now is an excellent opportunity to change the narrative,” he says, “because the drug supply is no longer just contaminated with fentanyl, it is fentanyl.”

Because fentanyl is readily available and so potent, people from all walks of life are prone to overdose. “If there’s any silver lining, it’s that views are shifting and we’re finally seeing more acceptance of the test strips and other harm reduction methods that save lives,” he says. 

Losing the Battle

 Even as the strips become more widely decriminalized, they remain an imperfect solution. While the strips are accurate at  detecting fentanyl and its analogues, they don’t tell you how much the substance contains. 

According to Ferguson, the high expense of drugs and the legal risk of obtaining them means that users may be unlikely to toss out a supply of drugs even if a test strip shows signs of fentanyl. And there’s also the risk of a false positive result. A May 2020 study published in the International Journal of Drug Policy found that the strips returned a false positive 10% of the time. This means that the test reads positive when it contains no fentanyl. 

More concerning is the risk of false negative results, especially in pressed pills. The CDC calls it the “chocolate chip cookie effect.” Fentanyl clumps in pill form so when you cut into the pill to test the drug, it’s possible that a portion is free of fentanyl when the pill contains it. The International Journal of Drug Policy study found that false negatives occur in 3.7% of cases. 

What’s more, fentanyl’s potency means that some users are addicted to the high it provides and may be seeking it out rather than avoiding it, says McIlveen. The more the drug supply contains fentanyl, the more users become addicted to it because it’s 50 times more powerful than heroin 

The drug supply is also constantly changing and it’s hard for the strips to keep up. New contaminants like xylazine, a powerful sedative used in cattle and horses, have recently overtaken the opioid marketplace. Xylazine can’t be detected using the strips.

Nora D. Volkow, MD, director of the National Institute on Drug Abuse, says fentanyl test strips need to be available for free throughout the country along with a steady stream of other harm reduction tools, namely naloxone. 

“Currently, an opioid user may see someone overdosing and they don’t have enough naloxone on hand to stop it from happening,” she says. 

Other medications like buprenorphine and methadone help wean patients off fentanyl and other opioids, but they’re not available in many parts of the country. Patients may get a prescription from their doctor, but the pharmacy in their area can’t fill it because they don’t have the medication. 

There are some effective treatments for saving people, such fentanyl test strips, naxolone, syringe service programs, buprenorphine, and methadone, but states are not providing them consistently. In West Virginia, for example, 62% of convictions were for drugs and the state also had the highest number of drug overdose deaths in the nation. The hope is that in the future, more resources will point toward harm reduction rather than incarceration. 

“Discrimination and stigma have resulted in laws that are interfering with the survival of people who take drugs,” Volkow says. 

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Tracking the opioid crisis: Inside the DEA’s secret lab | CNN

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Watch CNN Films’ “American Pain” at 9 p.m. ET Sunday, February 5.



CNN
 — 

Sitting among the warehouses of Dulles, Virginia, is one of the US Drug Enforcement Administration’s forensic labs. It’s one of eight across the country where scientists analyze illegal drugs and try to stay ahead of what’s driving deadly overdoses.

Starting in the late 1990s with overprescribing of prescription narcotics, the opioid epidemic has continued to plague the United States for decades. What has changed is the type of drugs that have killed more than half a million people during the past 20 years.

CNN was granted rare access to the secret lab where the DEA tests seized illicit drugs to understand what’s coming next.

“The market is constantly changing, so we are trying to do everything we can from a science base to keep up with that,” Scott Oulton, deputy assistant administrator of the DEA’s Office of Forensic Sciences, told CNN Chief Medical Correspondent Dr. Sanjay Gupta.

Holding a white bag of fentanyl precursor powder – one of the chemicals used to make the opioid – Oulton explained that the illicitly made painkiller continues to be a dominant presence in the drugs officials are finding.

“This kilogram can be converted into fentanyl to make approximately 800 grams,” he said. “So it doesn’t take that much material, it’s fairly cheap, it’s inexpensive to obtain.”

Fentanyl is the deadliest drug in the United States, and it’s often found in combination with other illicit drugs, including cocaine and heroin. But increasingly, fentanyl is showing up in illicit pills disguised as common prescription drugs like oxycodone, hydrocodone, even Adderall.

Users buying drugs on the street that look like prescription pills may end up with a highly potent, potentially deadly drug they never intended to take.

“Over 99% of what we see are fake. They contain fentanyl,” Oulton says of the pills that the agency is seizing.

The 800 grams of fentanyl that Oulton held could be turned into 400,000 to 500,000 potentially lethal pills.

As more and more of these lethal pills circulate, the opioid epidemic is reaching more of the population.

Deena Loudon of Olney, Maryland, is among those living with its effects.

“I truly love sharing Matthew with the world,” Loudon says as she flips through pictures of her son.

One of her favorite memories is Matthew playing hockey – what Loudon calls his happy place.

Matthew Loudon's mom says he turned to drugs after struggling with anxiety.

But she also recalls his struggles with anxiety, which led him to turn to drugs. He started dabbling in them in the 10th grade. By the following year, his grades began to fall, and he couldn’t keep them high enough to stay in hockey.

“He was using Xanax to help self-medicate himself and I think to help get rid of some of that angst so he could live somewhat of a normal life,” Loudon said.

Matthew was always honest, almost to a fault, Loudon says. “He told me he tried everything. Like everything. Heroin, meth, crack, you name it, cocaine, whatever – until I guess he found what made him feel the best, and it was Xanax.”

And as much as a mother can worry, Loudon says, Matthew always tried to reassure her. “I know what I’m doing,” he would tell her.

She had heard about fentanyl showing up in pills in their area.

“But you don’t ever think it’s going to happen to you,” Loudon said.

She said they even had a conversation about fentanyl the day before he died. “I was sort of naive, wanting to stick my head in the sand and thinking ‘I bet he does know what he’s doing.’ ”

On November 3, 2020, she found 21-year-old Matthew on the floor of their basement.

Matthew’s autopsy report lists his cause of death as fentanyl and despropionyl fentanyl intoxication.

“I don’t say he overdosed. I say he died from fentanyl poisoning. … Truthfully, like, at the end of the day, to me, he was murdered, right? Because he asked for one thing. They gave him something different. And it took his life.”

For a parent, she said, the hardest thing is burying their child. It’s a pain she speaks out about in hopes of keeping other families safe.

“It’s Russian roulette,” she warns them. “You never know what you’re gonna get.”

The number of pills the DEA has seized skyrocketed in just three years, from 2.2 million in 2019 to 50.6 million in 2022.

The sheer volume of pills has been one of the biggest challenges for the DEA’s lab, Oulton says. As the fentanyl threat continues to grow, the Virginia facility is expanding to accommodate the analysis needed.

The lab can test for something as simple as the presence of fentanyl, but something called the purity of the pill also offers important insight. This means how much fentanyl is actually in one of these illicit pills.

“Lately, we’ve been seeing a purity increase over the last year, where we used to say roughly four out of the 10 seizures that we were receiving would contain a lethal dose of greater than 2 milligrams. As of October last year, we started reporting that we’ve seen an uptick. Now we’re saying that six out of 10 of the seizures that we’re receiving contain over 2 milligrams,” Oulton said.

He says they’re finding an average of 2.3 milligrams of fentanyl in each pill.

Two milligrams may be the cutoff for what is considered lethal, but Oulton says that doesn’t necessarily mean a pill with 1.99 milligrams of fentanyl can’t be deadly.

“One pill can kill” is his warning.

“The message I would like to send out is, don’t take it,” he said. “Don’t take the chance. It’s not worth your life.”

Oulton says he and his team are constantly finding new and different drugs and substances in pills – things they’ve never seen before.

One machine in the lab is almost the equivalent of an MRI in a medical office, showing the structure and detail of a pill.

“We will do what we call structural elucidation to determine that this is a different version of a fentanyl that’s got a new compound and molecule that’s been added to it,” Oulton said.

They’ve seen “hundreds and hundreds of unique combinations,” he said.

“We’ll see one that contains fentanyl, one with fentanyl and xylazine, one with fentanyl and caffeine, one with fentanyl and acetaminophen, and you don’t know what you’re getting.”

Xylazine, a veterinary tranquilizer, poses a unique problem. It’s not an opioid, so even when it’s mixed with fentanyl, drugs designed to reverse an opioid overdose may not work.

Narcan or naloxone, one of the more common overdose-reversing drugs, has become increasingly necessary as the prevalence and potency of illicit drugs increases. About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier.

Oulton wants to be clear: The problem Isn’t with pills prescribed by your doctor and dispensed by a pharmacy – it’s the pills on the illicit market.

Those, Matthew’s mother warns, are easy to get.

“The first pills [Matthew] got was in high school. And it was just flipping out, floating around, and it was easy for him to get his hands on,” she said.

Loudon’s message for parents now: Keep your eyes open.

“Just be mindful of what your children are doing. You just just have to keep your eyes open. And even sometimes, when you keep your eyes open, you can miss some of the warning signs, but I think a parent knows their child best, so just keep talking.”

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