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When people are poised to participate in risky activities, they are supposed to follow safety protocols. For example, sky divers exercise proper precautions and procedures before each jump. No commercial airplane can take off until the flight attendants run through a checklist of announcements and make sure every passenger is wearing a seat belt. Why then can doctors prescribe medicines to patients without mentioning if there is a boxed warning?
How Careful Are You About Red Lights & Sirens?
You can’t drive a modern motor vehicle without fastening your seat belt. If you try, an annoying sound will remind you to buckle up. Do you comply? What about your passengers? Do you ask them to strap in? Most people obey the law to protect themselves and their passengers.
When a fire engine, police car or ambulance speeds by, a siren and flashing lights warn everyone to get out of the way. Do you pull over?
When you drive up to a railroad crossing, bells ring, lights flash, and a gate may come down to block the road if a train is coming. Do you stop or try to outrun the train?
Why Does The FDA Require BBWs [Black Box Warnings]?
The FDA requires a boxed warning on the prescribing information for a surprising number of frequently-prescribed medications. These alerts are intended to alert prescribers to adverse reactions that are so serious (“fatal, life-threatening or permanently disabling”) that they must be weighed carefully before the prescription is written.
In theory, these black box warning should also prompt prescribers to alert patients about dangerous drug interactions or symptoms that might require immediate medical attention.
How Can People Find a List of Drugs With Boxed Warnings?
Many patients receive prescriptions without being told about potentially serious side effects. I have looked high and low for an FDA list of drugs that carry a black box warning. It seems so basic, yet I have been unsuccessful.
A research letter in JAMA Internal Medicine (May 10, 2010) reports:
“Surprisingly, an official list of drugs with FDA boxed warnings does not exist.”
The authors go on to state:
“We found 416 marketed prescription drugs with a boxed warning in the current prescribing information…
“The boxed warning alerts health care providers of a greater-than-usual risk for an adverse effect that could lead to significant patient harm or death from use of a drug.”
If there were over 400 drugs with boxed warnings in 2010, I am confident that there are a lot more in 2024! Many of the latest pharmaceuticals now come with some very serious adverse reactions.
Why Don’t Health Professionals Warn Patients About a Boxed Warning?
For reasons that mystify me, prescribers (doctors, physician associates and nurse practitioners) and pharmacists often ignore what was once called a black box warning (BBW). The FDA has shortened that designation to “boxed warning.” It’s the same thing.
I suspect that one reason so many health care professionals ignore these critical advisories is that they fear such warnings will scare patients. Many prescribers may assume that a black box warning is not that big a deal. Maybe the FDA made a mistake. Why worry patients unnecessarily?
Then there is the fear factor. If a doctor tells a patient that the FDA requires a warning that the medicine about to be prescribed could cause a deadly reaction, the patient might be a little less willing to swallow it.
Do Doctors Ignore BBWs?
Sometimes a boxed warning indicates that a prescriber should not prescribe a drug either because of a very risky interaction potential or medical condition. In 2006 a team of health professionals wondered how well doctors adhered to “FDA drug prescribed warnings.” The subtitle to their research in Pharmacoepidemiology and Drug Safety (June 2006) was:
“is the black box half empty or half full?”
The investigators analyzed the medical records of 216,694 enrollees in 10 health plans. There were 19 medications with black box warnings on their research list.
They wondered how cautious or “compliant” prescribers would be when it came to boxed warnings.
“The finding that more than 40% of ambulatory care patients received at least one potentially relevant BBW medication during a 30-month study period, and that compliance with BBWs was highly variable, indicates the need for better methods of ensuring the safe use of medications that are considered to carry serious risks. BBWs are the FDA’s primary instrument to protect the public from potentially dangerous effects of medicines. No comprehensive official list of BBW medications or clear guidelines as to which events prompt a BBW exist, and whether they are an effective safety tool remains controversial.”
This really scared me about this study:
“Most non-compliance occurred with recommendations for baseline laboratory monitoring (49.6% of all therapy initiations that should have been accompanied by baseline laboratory monitoring were not).”
In other words, many of the drugs with black box warnings encouraged clinicians to perform “baseline” lab tests before prescribing the medication. Half the time, though, those labs were not requested.
Do Prescribers Read or Remember Boxed Warnings?
We have no way of knowing how often prescribers double-check for black box warnings. However, we have heard from many readers that too often the boxed warning cautions are not shared with patients.
Amiodarone:
One example is a heart medicine called amiodarone. The indications are surprisingly restricted:
“documented, life-threatening recurrent ventricular fibrillation.”
Yet many people report receiving it off-label for atrial fibrillation with no mention of a black box warning.
Here is just one story:
“I am currently on oxygen 24/7 because of lung damage from being on amiodarone. I developed pulmonary fibrosis after treatment for heart issues. I also had to be treated for hypothyroidism due to amiodarone as well. My cardiologist NEVER once said one word or warning about this drug.”
You can read many more accounts of devastating reactions to amiodarone at this link.
Fluoroquinolone Antibiotics (Cipro, Levaquin, etc.):
Another reader shares a story about a category of antibiotics called fluoroquinolones.
They come with a boxed warning about numerous severe side effects.
“A decade ago, I was prescribed Cipro (ciprofloxacin) for a urinary tract infection. In the middle of my treatment, while sitting in my recliner, I suffered spontaneous ruptures of both Achilles tendons. A week later I developed de Quervain tendonitis in my wrist.
“Neither my primary care doctor nor the orthopedic surgeon could explain why. These doctors did not warn me because they did not know Cipro can cause severe tendon damage. I showed them the black box warning. Since then I have had multiple tendon ruptures. Cipro has ruined my life.”
You can read many more tragic accounts of fluoroquinolone toxicity at this link.
Antidepressants:
We have heard from distraught relatives who lost family members to suicide. Most had not been informed that there is a black box warning about suicide risk in the prescribing information for many antidepressants.
Here is one story from a survivor:
“I tried to commit suicide while doctors were looking for an antidepressant that would help me with anxiety. Five different medications all made me feel worse. I never would have tried suicide if I weren’t on medication. Thank goodness I was not successful and am enjoying life to the fullest now.”
Trust me when I tell you that this is just the tip of the iceberg. Why don’t prescribers warn patients and family members about this potentially deadly reaction? Here is a link to an article we wrote about antidepressants and suicide. We were among the first to write about this connection, long before the FDA or drug companies recognized the risk.
Here is one last drug for your consideration:
Singulair (Montelukast) for Asthma:
This article is heartbreaking. It details the FDA’s handling of an asthma medicine called monteluikast (Singulair). It is titled:
“Should Prescribers Discuss FDA’s Drug Warnings“
We think this post puts the whole black box warning issue into sharp focus. It led us to start lobbying the FDA to make BBW information more transparent to patients.
Final Words:
We have received countless stories from individuals and families that have been harmed because no one alerted them about boxed warnings. We believe patients and their families must be informed when a prescribed medication comes with a black box warning.
If providers or dispensers are unable or unwilling to discuss extremely important hazards with patients and/or their families, people should have direct access to this information before starting the medicine.
What Can You Do?
Before taking any medicine, please go to DailyMed. This is the official prescribing information for almost all pharmaceuticals distributed in the US. It is maintained by the U.S. National Library of Medicine. If there is a boxed warning, you will often (but not always) find it at the very top of the drug information.
Do a test for yourself. Here is a link to amiodarone. It is right at the top of the information for prescribers. Or give Prozac (fluoxetine) a glance at this link. You will see the warning about suicidal thoughts and behaviors right at the top.
A Final but Crucial Message!
Just because a medication has a black box warning does not mean it should be avoided! There are many instances when it is entirely appropriate for a prescriber to recommend a medication that comes with a boxed warning. As long as patients and their families are made aware of the risks, we have no problem with people taking such medicines.
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Tyler
I was prescribed diclophenac cream for advanced degenerative osteoarthritis in my ankle. The doctor said nothing about any side effects that might occur. I broke out in a terrible rash that ended up going systemic, eczema-like lesions popping up all over me. I also found out about other terrible things that can happen, such as cardiac issues. I’m still trying to clear up the rash. When I asked the doctor about it he just shrugged & said “ It’s rare but it happens”. Maybe not so rare, I expect.
Alice
Should any of us ever take anything these days without doing our own research first? :-)
Linda
Another excellent article by your team. I’ve had two family members who suffered severe tendon injuries while on Cipro, one of whom almost lost her life due to multiple complications post surgery for dual achilles tendon ruptures. Same patient also broke her femur due to DECADES of Fosomax.