Black Box Warning – The Strongest Consumer Warning FDA Can Issue

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What is a Black Box Warning Label?

If your prescription medication or medical device carries a boxed warning or “black box warning” label, you may be wondering how this differs from other medication warning labels.

Black box warning labels are issued only after sufficient and credible data has indicated that there is an association between the medication or medical device and an increased risk of serious injury or death that was not previously included on the medication’s warning label.

A black box warning is the strongest consumer warning that the Food & Drug Administration (FDA) can issue for prescription drugs and medical devices.

Black box warnings are commonly issued as a result of numerous, collaborative consumer adverse event reports for a certain medication or device.

The warning is designed to make consumers and medical professionals aware of any adverse effects, side effects, or increased health risks associated with the product.

The FDA is also the government agency in charge of pre-market approval of pharmaceutical drugs and medical devices.

Not all adverse side effects or health risks are recognized during the pre-market trial process, so the agency does not always include these effects and risks on the initial warning labels.

When new drug and device health risks become apparent, after the drug or device has been approved for market by the FDA, the agency relies on medical professionals, consumers, and manufacturers to report any adverse events or newly discovered risks to the FDA reporting system, FAERS.

The Office of Surveillance and Epidemiology (OSE), which operates within the FDA, monitors the FAERS database for adverse event submissions.

If the FDA finds that there is sufficient data to support FAERS submissions, the agency will initiate the process of informing consumers of these newly discovered health risks by issuing a public warning called a drug or device safety communication.

It is important to note that the FDA continues to research and monitor drugs and devices after they come to market.

However, due to the high number of drugs and devices available and limitation of resources, the FDA’s ability to comprehensively monitor all drugs and devices is very limited.

The agency, therefore, relies heavily on outside resources, such as consumer and healthcare provider reports, manufacturer research, and third-party research to monitor the safety of these products.

Drug and Device Safety Communication

If a drug or device is perceived to be linked to a health risk not included on the product warning label, the FDA will issue a public drug or device safety communication, making consumers and healthcare professionals aware of the potentially new health risks associated with a drug or medical device.

The relationship between the product and the risk does not have to be casual, but there does need to be enough credible evidence to make an argument that the two are likely related.

Healthcare professionals are legally required to make all new and current patients aware of any new risks associated with the drug or device, including all FDA safety communications.

Patients who were previously prescribed a drug, but no longer take the drug, should stay informed of all new safety communications associated with their medication.

Healthcare providers are not obligated to inform patients of newly discovered health risks associated with a drug that the patients had previously been prescribed to but is no longer prescribed.

Patients who have previously received a medical device should also stay informed with any device safety communications associated with their device.

While healthcare professional will likely inform them of any new or emerging safety risks, they are not obligated to do so, especially if the healthcare professional is not the person who originally prescribed the treatment.

Why Do Drugs and Devices Receive Black Box Warning Labels?

Unfortunately, gaps in oversite for medication and device approval allow for life-threatening health risks to be overlooked or missed during the pre-market process.

This is especially true when products are rushed to market because the long-term effects of the drug cannot be properly studied.

The FDA has faced scrutiny for its lax and unsafe premarket-approval process, including implementing shortcuts to speed up the drug and device approval process to allow pharmaceutical companies to rush their products to market.

Although these shortcuts were apparently established so that drug and device manufacturers could get their products to patients in need in a timely process, it has also allowed for the lapse in the safety of some drugs and devices.

The result of rushing these products to market is that product safety is not properly conducted.

In a study conducted by the Yale School of Medicine, researchers found that nearly a third of medications approved from 2001 to 2010 had “major safety issues” as a result of the current approval process.

Because of these flaws in market approval, a number of drugs and devices that are made available to consumers pose serious risks – especially long-term user risks and risks to patients with predispositions – that are not initially recognized during market approval.

If FAERS receives enough adverse event reports or there is enough data linking a product to an adverse effect, the agency will begin the process of conducting research to determine whether the product should carry a black box warning.

If concurrent findings from FDA in-house studies and/or credible third-party research links a drug and device to adverse effects resulting in serious injury or death that are not listed on the drug or device warning label, the FDA will require the manufacturer to add a black box warning label to the product, so that patients are aware of the new risk(s) associated with the product.

When the FDA issues a black box warning for a drug or device, the agency will release a public announcement informing all consumers and medical professionals of the black box warning label.

The warning will also be added to all new medications or devices manufactured by the company, literally as a black box label – similar to the black box label found on a pack of cigarettes – hence the name “black box warning”.

The most common type of black box warning is specific to certain high-risk patients – that is, patients whose current medical conditions put them at a greater risk of serious injury or death while using the medication or device.

This can also be true of patients who are already prescribed a certain medication or who already have a medical device that does not interact well.

However, not all black box warnings are limited to only patients with a predisposition and can be meant to warn all consumers using the drug or device.

Once a product is issued a black box warning, safety alerts go out to both consumers and medical professionals through various outlets such as public safety announcements, letters to health care professionals, medical media outlets, and the FDA website.

All black box warning labels and drug or device safety warnings can be found on the FDA’s official website.

After the public has been notified, it is up to the patient or doctor to evaluate whether the risks outweigh the benefits of the drug or device.

Like safety communications, only future patients and patients currently being prescribed the drug or device are required to be made aware of the additional risks, so it is important that previous patients stay informed with any new black box warning labels their previous drug or device may carry.

With any drug, there are both risks and benefits.

It is important to have a serious discussion with a healthcare professional about the potential risks and benefits of any prescription drug or medical device that carries a black box warning.

In the case you have been injured by a side effect that was not listed on the drug or device’s label but now is – including black box warning labels included on a drug or device after you received the drug or device – please do not hesitate to reach out to a personal injury lawyer.

The drug’s manufacturer should be held responsible for failure to properly warn consumers about dangerous or deadly side effects, and you may be entitled to compensation for your injuries.

Contact the offices of TorHoerman Law if you believe that you may have a drug or device injury case.

Our experienced team of personal injury lawyers would be happy to discuss your potential case, no-obligation and free of charge.

“A Guide to Drug Safety Terms at FDA.” A Guide to Drug Safety Terms at FDA,

“What Is a Black Box Warning on a Prescription Drug?” Health Information | Ask a Pharmacist, Walgreens,

Lupkin, Sydney. “One-Third Of New Drugs Had Safety Problems After FDA Approval.” NPR, NPR, 9 May 2017,



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