Key Takeaways
- In September 2020, the FDA required an updated boxed warning on every benzodiazepine.
- The warning names abuse, misuse and addiction separately from physical dependence, which can develop even when the medication is taken as prescribed.
- It warns that stopping abruptly or reducing the dose too quickly can cause withdrawal reactions that may be life-threatening.
- The labeling describes protracted withdrawal, with symptoms that can last weeks, months, or longer than a year.
- Prescribers are told to taper gradually and to consider pausing or returning to the previous dose if withdrawal reactions develop.
- The warning does not say benzodiazepines can never be prescribed, and it sets no deadline for coming off.
What does the 2020 FDA warning on benzodiazepines actually say?
In September 2020, the US Food and Drug Administration (FDA) required a change to the boxed warning on every benzodiazepine sold in this country. That includes Xanax (alprazolam), Klonopin (clonazepam), Ativan (lorazepam), Valium (diazepam), and the rest of the class. The agency said plainly that the existing prescribing information did not give adequate warning.
So, what are the risks? The updated box describes abuse, misuse, and addiction. It describes physical dependence that can develop with continued use. And, it describes withdrawal reactions, some of them life-threatening, when the drug is stopped abruptly or the dose is reduced too quickly.
Many people who take these medications have never seen the warning, and I suspect that some prescribers have not read it closely either. What does it say in plain words, and what does it change when you sit down with your doctor?
A boxed warning is literally a box with a warning in it
A boxed warning is the strongest warning the FDA places on a prescription drug. It is printed inside a black border at the very top of the prescribing information, the long technical document that doctors and pharmacists are supposed to consult. Many people call it a black box warning.
The 2020 update did not stop at the box. The FDA also required changes to the sections of the label on warnings and precautions, on drug abuse and dependence, and on what prescribers should tell their patients. The Medication Guide changed too, which is the folded sheet stapled to your pharmacy bag that most of us throw away with the receipt.
The box names addiction and physical dependence as two separate things
Read the warning closely and you will notice that it does not blend these ideas together. Abuse, misuse, and addiction are described in one part. Physical dependence and withdrawal reactions are described in another.
That separation matters, because physical dependence is not addiction. Physical dependence means that your nervous system has adapted to the steady presence of a drug, so that reducing the drug produces withdrawal. In fact, the FDA stated that dependence can develop when a benzodiazepine is taken steadily for several days to weeks, even as prescribed.
Addiction is a different medical condition, defined by behavior, such as compulsive use in spite of harm. People who have an addiction deserve respect and real medical treatment. Yet, most of the people I hear from about benzodiazepines took their pills as directed for years. Their condition came from the prescription.
Why does the warning single out stopping abruptly?
The box states that abrupt discontinuation or rapid dosage reduction after continued use may bring on acute withdrawal reactions, and that these can be life-threatening. The FDA’s announcement and the warnings section of the label name seizures specifically.
Call 911 or go to an emergency department if any of these happen after a dose is stopped or reduced:
- A seizure.
- Confusion or hallucinations.
- Thoughts of harming yourself.
If you are in a mental health crisis, you can also call or text the 988 Suicide and Crisis Lifeline at any hour.
The labeling also describes a protracted withdrawal syndrome, with symptoms that can last for weeks, for months, or for longer than a year. Patients and advocates use the term benzodiazepine-induced neurological dysfunction, or BIND, for symptoms that appear during and after a taper, and sometimes while a person is still taking the same daily dose. While the label does not use that term, it does admit that withdrawal can last far longer than most doctors were taught.
Patients have described to me raising these symptoms and being told that the dose was too low to cause withdrawal, or that the old anxiety had simply come back. Since 2020, the drug’s own label disagrees.
What does the FDA say about how to come off a benzodiazepine?
The answer is short. Use a gradual taper. The box tells prescribers to reduce the dose gradually, whether the goal is to stop the drug or only to lower the dosage.
Interestingly, the FDA also told prescribers that no standard tapering schedule is suitable for all patients, and that the plan should be specific to the patient. The labeling goes a step further. If withdrawal reactions develop during a taper, the prescriber is advised to consider pausing, or going back up to the previous dose, and then decreasing more slowly.
I believe these may be the most useful sentences in the whole update. They say, in the government’s own words, that there is no one-size-fits-all schedule. They also say that holding a dose is a legitimate part of tapering. It is not a failure.
The sign went up after many people were already on the road
Imagine that you have driven the same mountain road every day for ten years. One morning, a new sign appears at the top of the long downhill stretch. It says that the grade is steep, and that you must not brake suddenly.
The sign is correct, and it may save the next driver. Yet, it is ten years late for you, and it does not tell you how to get down the mountain. While this is not a perfect analogy, it is close to what the 2020 warning means for a person who started Klonopin or Xanax long before anyone mentioned dependence.
Genuine informed consent means hearing about the risks before the first prescription, along with the alternatives, including no medication at all, a plan for eventually coming off, and the right to say no at any point. Many patients never had that conversation. We asked why psych meds are prescribed so often in the episode on the film Medicating Normal.
So, the sign’s one instruction still applies. Do not slam on the brakes. You get down the mountain slowly, in low gear.
Unfortunately, a warning can be misread as an order to stop
Here is what the update does not say. It does not say that benzodiazepines can never be prescribed. It does not say that every patient must come off them, and it sets no deadline.
Unfortunately, some prescribers react to a strong warning by becoming nervous about the prescription itself. A patient who has been stable for years may suddenly hear that the dose will be cut quickly, or that the refills are ending. That is exactly what the box warns against.
The same error happens when a dependent patient is sent to a detox or rehab program built around a calendar of insurance days. A facility that promises to have you off a benzodiazepine in a week or two is performing a rapid dosage reduction, whatever the brochure calls it. Such programs may do good work for other conditions. This is not one of them.
What changes when you talk to your prescriber?
The label is public. The full prescribing information for every benzodiazepine is posted on DailyMed, the label website of the National Library of Medicine. It is not a bad idea to print the boxed warning and the section on dependence, and bring them to your appointment.
You may feel uneasy about handing your doctor a printout, which is understandable when a doctor’s prescription is how you got here. Still, you might be surprised. Some doctors have simply never read the updated box, and most will take the FDA more seriously than they take a podcast.
What can you ask for? You can ask that any reduction be gradual, that the schedule be built around how you respond, and that a pause be allowed when symptoms flare. The label supports all three. If the taper is too fast, the label’s own advice is to slow it down, and if you are doing well, the two of you may agree to go a bit faster, as tolerated.
If your doctor is not comfortable with a slow taper, it is reasonable to look for one who is. The Benzodiazepine Information Coalition, whose medical advisory board I serve on, teaches the public and the profession about harm from benzodiazepines taken as prescribed. My conversation with Christy Huff, M.D., about the coalition is a good place to hear more.
Fortunately, the slow way down was already mapped
Fortunately, the FDA did not have to invent gradual tapering. Professor C. Heather Ashton described it years earlier in what we now call the Ashton Manual. Her method includes the crossover taper, in which a patient moves from a short-acting benzodiazepine to a long-acting one, such as Valium (diazepam), before the slow reductions begin.
I am partial to Professor Ashton’s method, but it is not the only safe one. The Maudsley Deprescribing Guidelines describe hyperbolic tapering, in which each reduction gets smaller as the total dose gets lower. Some patients do better with very small, frequent reductions made with a liquid formulation.
What these methods share is what the label now asks for. The taper is slow, it is supervised by your doctor, and it is paced by you. I give no numbers here, because the right numbers are the ones you and your prescriber work out together.
The 2020 warning did not repair what happened to the patients who were never told. It did put the truth in writing, at the top of the label, where no one can say it is not there. With time, and a taper that moves at your pace, the nervous system can heal.
This article is educational. It is not medical advice, and reading it does not create a doctor-patient relationship. Decisions about starting, continuing, or tapering any medication should be made with your own physician.
