Compounded Naltrexone: What to Know About Efficacy, Approval & Risks

Is your naltrexone pure or compounded? Some providers sell compounded naltrexone with other ingredients mixed in even though it isn’t FDA approved.

SHORT ANSWER: Compounded naltrexone refers to medication that is a blend of ingredients, with naltrexone being the primary substance. Often compounded naltrexone includes an additive like vitamin B. The problem with compounded naltrexone is it isn’t FDA-approved for safety or efficacy like pure naltrexone.

What You’ll Learn:

• What qualifies as standard FDA-approved naltrexone.

• What is meant by compounded naltrexone.

• The important regulatory differences between pure naltrexone and compounded naltrexone.

• The potential risks of using compounded naltrexone.

If you've been researching naltrexone for alcohol use, you've probably come across compounded versions advertised online, often as cheaper, customized or lower dose alternatives. Before you decide to try compounded naltrexone, it helps to know what it is, how it differs from the FDA-approved medication and what the research does and doesn't show.

Consider this your crash course on compounded naltrexone.

What is Considered Standard, FDA-Approved Naltrexone

Naltrexone is a prescription medication that blocks opioid receptors in the brain. By doing so, it can reduce the rewarding effects of alcohol and lower cravings. The FDA approved naltrexone for both alcohol use disorder and opioid use disorder. The standard oral form has been on the market for decades and is available through brick-and-mortar and online pharmacies.

What is Compounded Naltrexone?

Compounding is when a pharmacy prepares a medication from raw ingredients, often to tailor it to an individual patient. Compounding can serve a real purpose, such as making a liquid for someone who can't swallow pills or removing an allergen like a dye.

Compounded naltrexone is naltrexone that’s prepared this way. It may come as capsules in nonstandard strengths, liquids, troches (dissolvable lozenges), creams or even implants or injections. A common example is low-dose naltrexone (LDN), usually capsules or liquid at a fraction of the standard dose.

How Compounded Naltrexone Differs From Standard, Pure Naltrexone

The change in the formulation may not seem like much, but the key differences between compounded naltrexone and pure naltrexone are important.

• FDA-approved naltrexone has been reviewed for safety, effectiveness and manufacturing quality. Each tablet is made to a set standard, so the dose is consistent and the labeling is based on clinical evidence.

• Compounded naltrexone is not FDA-approved. The FDA doesn't review compounded drugs for safety, effectiveness or quality before they reach patients. Quality depends on the individual pharmacy's practices, ingredients and testing.

Compounded versions also may not match the approved product in strength, how the drug is absorbed or how long it lasts, which makes it hard to know what you're actually getting.

What the Research Says About the Efficacy of Compounded Naltrexone Compared to FDA-Approved Medication

For FDA-Approved Naltrexone: The evidence for using naltrexone for alcohol use disorder is well established. Clinical trials and systematic reviews, including Cochrane reviews, found that naltrexone can reduce the risk of returning to heavy drinking and lower the number of drinking days for many people. Results vary from person to person, and the medication tends to work best alongside counseling and support in the initial stages of treatment.

For Compounded Naltrexone: There is a significant gap with compounded naltrexone. We're not aware of robust clinical trials showing that compounded formulations are effective or safe for alcohol use disorder. Because they aren't FDA-approved, there's no requirement to show they work the same way as the approved medication.

For Low-Dose Naltrexone: Researchers have explored LDN for conditions like fibromyalgia, chronic pain and some autoimmune and inflammatory conditions. Most of these studies are small, and larger, higher-quality trials are still needed. LDN is not an FDA-approved treatment for any of these uses, and its role in treating alcohol use disorder is not established.

In short, the evidence supports FDA-approved naltrexone for alcohol use disorder. The evidence for compounded versions is limited or altogether absent.

The Potential Risks Associated With Compounded Naltrexone

The greatest concern with medications that aren’t FDA-approved is safety. Compounded naltrexone comes with potential risks in addition to common side effects. The risks include:

• Inconsistent dosing. Compounded products can contain more or less medication than intended. Too little may mean it doesn't work, and too much raises the risk of side effects.

• Quality and contamination concerns. Without FDA review of manufacturing, there's more room for variation in ingredients, purity and sterility.

• Unpredictable absorption. Creams, troches, liquids and implants haven't been shown to deliver naltrexone to the body in the same way as the approved tablet.

• Unproven long-acting products. Compounded implants and injections can release the drug unevenly or for an unknown length of time, which is hard to reverse if something goes wrong.

• Less safety information. With no clinical trials behind them, the side effect profiles of compounded formulations aren't well characterized.

Because of these uncertainties, it's important to talk with a licensed clinician before taking any form of naltrexone, compounded or not.

In Summary:

Compounded naltrexone isn't the same as FDA-approved naltrexone. It hasn't been reviewed by the FDA, the evidence for its use in alcohol use disorder is limited and it carries added uncertainty around dose, quality and safety. For anyone who wants assurance that their medication is safe and effective, pure naltrexone is the way to go.

Only Proven Medications at Choose Your Horizon

At Choose Your Horizon, we only prescribe pure, FDA-approved naltrexone. That means a consistent dose, a product held to FDA quality standards and a medication with decades of research behind it for alcohol use disorder. If you're ready to explore whether naltrexone is right for you, our clinicians can answer your questions and help you decide on a next step.

Take the online Alcohol Use Assessment to get started.