Viewpoint: FDA Approval of Overdose Antidote Leaves Lives on the Table

The FDA approved on Thursday the equivalent of an “epi-pen” for overdose prevention, an antidote auto-injector that even untrained people can use to save the lives of those who have overdosed on drugs like Vicodin or heroin. Such opioid overdoses kill around 17,000 Americans each year.

While this first step is welcome, the antidote remains prescription only. But to save the most lives, it needs to be made available over-the-counter and be affordable enough to be included in every first aid kit in the country.

While it’s commonly thought that the only people who die of overdose are people with addiction, in fact, OD kills in many different scenarios. Grandma might mix up her meds and take them twice or even three times. Uncle Bob might forget that pain medication and alcohol shouldn’t mix. A toddler or a curious teenager might get into the medicine cabinet. And someone who struggled with addiction in the past might relapse: the highest risk times for overdose in addiction are initial use and then middle age, with peaks that also occur after periods of abstinence or incarceration. In many of these situations, relatives don’t realize that their loved one is at risk.

Another myth about overdose is that it typically occurs when people are alone. Research suggests that at least half of all overdoses are witnessed, but oftentimes the witnesses don’t know what they are seeing and “let them sleep it off,” which is basically the worst thing to do. Instead, if someone’s breathing is slowed or stopped, their skin is bluish, you cannot arouse them, and there’s any chance that overdose is the cause, calling 911, using naloxone, and performing rescue breathing is best.

Combined with greater awareness of these OD symptoms, the new drug delivery system could make a real difference. Called Evzio, it’s basically a sophisticated epi-pen. But instead of containing adrenaline to prevent potentially fatal allergic responses, it contains naloxone, a nontoxic FDA-approved drug that can instantly reverse potentially fatal overdoses that include opioids. (At least 2/3 of overdoses involve drug mixtures, but if one of the drugs is an opioid, Evzio will still work).

Evzio also has safety features that prevent the needle from being re-used, and recorded audio instructions that can guide people without prior training in how to save a life. There’s virtually no way to misuse it. Essentially, naloxone causes the opposite of a high and can induce distressing withdrawal symptoms in people who are addicted. Since the experience of being revived with it is unpleasant, using Evzio as “insurance” for excess that wouldn’t otherwise occur is unlikely to be a major issue. And it won’t harm even if given in error; since the only thing it does is block opioids, it doesn’t hurt in other types of OD or in other situations that cause people to lose consciousness.

Research already shows that making naloxone available to lay people in other forms is effective. A study of Massachusetts’ program published in BMJ found that not only did an intranasal version of drug revive 98% of victims to whom it was administered, it also cut the OD death rate in regions with high levels of availability by nearly 50%, compared to areas where it was less accessible.

MORE: Wider Distribution of Overdose Antidote Could Cut Death Rates By Nearly Half: Study

Since 1996, when activist Dan Bigg started the first naloxone distribution program in Chicago, around 200 such programs have sprung up in the U.S. Collectively, they’ve distributed more than 50,000 doses with at least 10,000 reported revivals. No serious side effects have come to light. The drug has been used safely in hospitals since the 1960s, and was approved for such use by the FDA way back in 1971. Last month, attorney general Eric Holder even urged that states make it available to all first responders. New York state announced Thursday a $5 million program to distribute it to police officers.

Experts agree that in an overdose situation, “time is brain.” The longer someone goes without oxygen, the worse the consequences and the more likely the overdose will be fatal. No parent I’ve spoken with has ever said that they would prefer not to have such a drug on hand if they ever came upon a blue and unconscious child.

Given this, and naloxone’s spotless safety record, there’s no reason to require prescriptions for it. And since no one can truly predict where and when an OD might occur, it should always be nearby if possible; hence first aid kits are the natural place for it. If everyone has it, no one has to feel singled out as potentially having an addicted person in the family; it’s just there for emergencies that could actually affect anyone.

Dr. Eric Edwards, the chief medical officer of Kaleo Inc., which makes Evzio, says that given naloxone’s safety profile, it’s possible that it may be made available over the counter in the future. “We think this is the first step to building the safety data needed to show that it can be used appropriately,” he says.

But people are dying every day, right now. It has taken at least 18 years from the time Bigg first distributed naloxone to get to this place, and more than four decades since the FDA originally approved naloxone for hospital use. Even the director of the National Institute on Drug Abuse, the agency charged with addiction research in the U.S., says it should be over-the-counter.

Says Bigg, “It sounds like [Evzio] is a big step forward, if it is affordable.” The price has not yet been made public.

And regardless of the price issue, is there really any reason to wait any longer to allow all types of naloxone to be sold over the counter? The FDA can choose to act on an emergency basis in terms of drug approvals if it so desires. With the availability of Evzio, there’s no justification for not doing so, other than the ongoing stigma of addiction.

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