In the United States, ‘black box warnings’, officially known as boxed warning, are the most serious required warning that appears on the package insert for prescription drugs approved by the U.S. Food and Drug Administration (FDA). The FDA demands that certain important warnings are formatted with a ‘box’ or border around the text and posted on a prominent package location.
Drugs having a black box around the warning means that a side effect of the medication may lead to death or serious injury.
Strictest Warning Mandated by FDA
First instituted in 1979, black-box warnings are intended to highlight a serious side effects that may be life threatening, fatal, or disabling.
This severe warning can be based on clinical data (studies involving human volunteers) or serious animal toxicity data. Sometimes a black box warning is necessary at the time a new drug is approved based off of minimal safety testing. Sadly, it is more common, that the warning is added only after the drug has been approved, sold, and the FDA starts receiving reports of serious side effects injuring the public. After the FDA reviews and confirms the serious risk, a boxed warning is implemented, depending on the severity of the side effect and only in collaboration with the pharmaceutical company.
What Can Trigger a Black Box Warning?
Data leading to a black-box warning can come from several sources, including clinical trials before or after FDA approval, statistical review of data from MedWatch and the FDA Adverse Event Reporting System, academic literature and media attention following such adverse events.
After FDA approval, the reports of consumer injury the FDA receives are completely voluntary. Some physicians will report patient information to the FDA directly, but they may not be able to identify the source or connection between the drug and the side effect. Consumers, family members, and lawyers can also file reports under the FDA Adverse Event Reporting System. Physicians and consumers may also report the dangerous side effect to the product’s manufacturer, who is required to relay that information to the FDA as well.
Another way to bring the FDA’s attention to harmful side effects is litigation over drug safety and its resulting media attention. In the past, lawsuits have successfully influenced addition of black-box warnings. For example, litigation over long-term use of the anti-nausea medication, Reglan, and a severe neurological side effect that caused involuntary facial movements, called tardive dyskinesia, led the FDA to add a black-box warning to the drug’s label in 2009.
Black Box warnings are commonly drug-specific, when the FDA has determined that the risks of a certain drug need an additional warning. However, they can also be prescribed for an entire class of drugs. For example, in 2008, a black-box warning was added to all fluoroquinolone antibiotics, including Levaquin and five other antibiotics, warning of increased tendon injuries in older patients, those on steroids, and transplant recipients.
What does a Black Box Warning look like?
As the name indicates, it is basically a warning in a prominent location with a black box around it. However, the language is created with heavy input from the drug manufacturer and is frequently very technical.
There are risks and benefits associated with taking any medication. The black box warning and other packaging warnings are designed to alert prescribers and users of the potential risks so that physicians and patients can make informed decisions. If you ever have concerns regarding your prescription medication, discuss them with your physician.
Were You Affected By Serious Pharmaceutical Side Effects?
The black box warning and other packaging warnings are designed to alert prescribers and users of the potential risks so they can make the informed decision about whether to use a medication. However, drug manufacturers have sold products they knew or should have known put the public at risk of dangerous side effects and failed to warn us of them. When a drug maker robs you of a chance to make an educated choice about your medication and you are harmed by the side effect, you may be entitled to compensation.
Watts Guerra LLP is an experienced team of trial lawyers that focuses on the representation of plaintiffs in pharmaceutical injury lawsuits.
Written by:
Paige Boldt
Watts Guerra LLP
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