It’s no secret that prescription drugs have risks. In fact, most drugs on the market today have some level of side effects, which can range from nausea or headaches to serious medical implications. Many of these side effects are found during the research stages of a drug’s approval, but some aren’t discovered until months or years after they’ve been used by consumers. For the most serious risks, the FDA steps in and orders a Black Box Warning.
What “Black Box” Means
In one sense, a black box warning (boxed warning) is exactly what it sounds like. On both the promotional materials and the medication guide for a boxed warning drug, you will find an actual black box around text that describes adverse reactions you might have during or after use.
But when industry professionals talk about boxed warning drugs, there is a negative connotation that goes along with it. Drugs only receive this label in the case of serious, often deadly adverse reactions, which have been reported to the FDA after the drug was originally approved. In some cases, the manufacturers of these drug hid their knowledge of the side effects to speed the approval process, so the problems weren’t found until after release.
A boxed warning is the FDA’s harshest warning, and the last stop before a recall notice. A study from 1998 broke down the criteria for placing a boxed warning on a medication. The researchers noted that the FDA might have one or more of the following reasons to add a boxed warning:
- Early knowledge of a side effect would allow physicians to monitor and intervene to prevent adverse events.
- Certain demographics of patients are at higher risk for a serious/deadly side effect.
- The risk of the drug may outweigh the benefits in certain situations.
- A wrong dosage or certain drug interaction might critically increase the risk.
- The drug must be administered by a specially trained physician or in a specific setting.
- The medication needs to be administered in a special way, or with extra caution.
The Adverse Event Reporting System
Since most of these serious or fatal side effects are discovered post-approval, reporting is a crucial way for the FDA to keep the public safe. Black box warnings were introduced in 1979, but since 2004, adverse events have been reported through the FDA’s Adverse Event Reporting System (FAERS).
FAERS allows industry professionals, including healthcare providers and pharmacists, as well as consumers, to report any concerning or undesired effect or side effect associated with a particular drug. While consumers are welcome to report issues voluntarily, physicians and other professionals are mandatory reporters, meaning they must report adverse events that they see in patients.
Once an event is reported to the system, the incident is reviewed by clinicians in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). If the reviewers are concerned, a deeper investigation begins. If that investigation brings forward red flags, the FDA is then able to take regulatory action. It’s at this point that the FDA could require a boxed warning to be added to a drug’s labelling and marketing materials. However, regulatory actions could also include other labelling restrictions, restrictions on how and when the drug can be used, and, in the worst cases, the reversal of FDA approval on the medication.
Why Black Box Warnings are Important
According to a 2006 study, nearly 40% of patients in ambulatory settings were prescribed drugs that had a boxed warning. In some of the recorded cases, pregnant women even received medications where the boxed warning made the drug contraindicated in pregnancy. With over 600 medications carrying these severe side effect warnings, it’s imperative that healthcare providers and patients understand what FDA warnings mean.
It’s not just extreme drugs or medications only found in hospitals that carry these warnings. Some of the most prescribed drugs in America carry black box warnings. Here are a few:
- Pradaxa: Commonly used as a blood thinner, Pradaxa’s warning actually has to do with stopping the use of the drug. While Pradaxa has an increased possibility of serious bleeding during use, stopping the drug before its course is complete may lead to a stroke or heart attack due to blood clots. Pradaxa lawsuits, however, are more focused on the risk of internal bleeding than strokes.
- Adderall: This drug is one of the top choices for patients with ADHD. In addition to being highly addictive, Adderall also has a boxed warning for increased risk of cardiac events and sudden death.
- Zoloft: Again, a drug found in hundreds of thousands of homes in America, Zoloft is commonly prescribed to help treat depression. Yet, the boxed warning on this drug notes that in certain demographics (including children and adolescents), Zoloft has been associated with an increased suicide risk.
- Invokana: This drug is prescribed to treat type 2 diabetes. However, recent studies have shown that patients who take drugs containing canagliflozin have a higher risk of below-the-knee amputations, leading to more than a thousand Invokana lawsuits filed against manufacturers.
Learning What You Need to Know
If you’re searching your medicine cabinets and seeing black boxes, don’t panic, and never stop taking a medication without speaking with your doctor first. A good physician will know about the warning, and will have assessed the risks and benefits in your situation before grabbing their prescription pad. If you’re concerned about any of your medications, here are a few questions to discuss with your physician. You can also always ask your pharmacist questions about medications; it’s their job to know these drugs better than anyone else.
Things to Ask Your Doctor or Pharmacist
- What does this warning mean? Often boxed warning labels have abbreviations or terms you might not understand. This helps keep the label as short as possible, while conveying important information to healthcare providers.
- Why did you prescribe me this drug in particular? Or rather, why is this drug safe for me? A side effect might look scary to you when you read about it, but depending on your particular circumstances, including age and medical history, the benefits may far outweigh the risks.
- Are there other drugs that could help me? If you’re really concerned about a medication, it’s reasonable to ask your doctor about other options. Have them talk you through the drugs available and the risks/benefits of each one.
- What is your drug representative policy? Many private practices and even some hospitals allow drug representatives to come in and pitch their medications to physicians. Some may offer kickbacks to physicians who prescribe certain drugs, which makes it difficult for doctors to be objective about medications. Your doctor should tell you if they work with reps from a certain company, or if their relationship with a drug representative pushed them to prescribe a boxed warning drug to you.
How to Report an Event
While your doctor is obligated to report adverse events they see or that you tell them about, it’s important to be proactive if you experience a concerning side effect. Luckily, the FDA makes it easy to report these types of events, which means you have a great way to help other consumers stay safe. If you or a family member has experienced a severe drug side effect that is not covered in the side effects section of the medication guide on the drug, there are a few ways you can alert the FDA.
- Submit an Electronic report: The FDA uses a system called MedWatch to track electronic complaints. You can visit them to submit complaints about serious drug side effects, medication errors/product use errors, product quality problems, and therapeutic failures. MedWatch should not be used for reporting issues with vaccines, investigational drugs (still under study), or dietary supplements.
- Mail It In: The FDA also provides a PDF of the report form, which you can print, fill out, and send back to them. Again, this form is only for approved medications, not supplements or vaccines.
- Call Them Directly: You can call the FDA at 1-800-FDA-1088 to report adverse events via telephone.
You can also check in on your report, or ask for the general information regarding adverse events linked to a drug. The 1996 amendments to the Freedom of Information Act give you the right to access this information at any time. Healthcare providers and third parties are also allowed to access the information, and may view your report, but they cannot see your patient files without written consent from you.
Taking Medications with Confidence
It’s important to remember that black box warnings are just that: warnings. They are meant to inform prescribing decisions, so that your physicians can make the best drug choices for you. It’s rare for any drug to have no side effects at all, and most affect every individual differently; medication is about what is the best option, not what’s perfect and risk-free.
If you’re ever unsure about a drug or its side effects, talk with your doctor or pharmacist, and make sure you’re being properly monitored for adverse events. Always follow dosing guidelines, and make sure to call for help in the case of a medication mix-up or drug overdose. In the case of an adverse reaction, help your fellow consumers by reporting the issue to the FDA. That way, we can take one more step toward ensuring the health and safety of every patient, whether they’re taking life-saving drugs for a severe illness or simply medicine to stem a winter cold.