When Dangerous Drugs Are No Longer Dangerous- The FDA and Black Box Warnings

Caroline Tait

Associate Editor

Loyola University Chicago School of Law, JD 2024

Black box warnings are assigned to prescription drugs by the U.S. Food and Drug Administration (FDA) to alert of serious sides effects, such as injury or death. The smoking cessation drug, Chantix, previously had one of these black box warnings attached to it, but that warning has since been removed. This transition from a “dangerous drug” to a non-dangerous drug raises various important regulatory concerns regarding the marketing of this drug and other popular prescription drugs as well as the role of the FDA in regulating “dangerous” drugs.


The FDA assigns box warnings, or “black box warnings” to prescription drugs where there is 1) an adverse reaction so serious in proportion to the potential benefit of the drug, or 2) a serious adverse reaction that can be prevented or reduced in frequency or severity by appropriate use of the drug, or 3) an FDA approved drug that has restrictions to ensure safe use.

Chantix is a prescription drug manufactured by Pfizer for use “as an aid to smoking cessation treatment.” In 2009, Chantix received its black box warning from the FDA after fears rose from reports that linked the drug to “psychiatric issues including suicidal thoughts, suicidal behavior, hostility, and agitation.” Since 2009, this label was removed from the drug after the FDA announced that these risks associated with Chantix are “lower than previously suspected” following a large clinical trial. Along with this removal of the label, the FDA issued a recall on all Chantix tablets, calling for wholesalers and distributors of the existing tablets to “stop use and distribution and quarantine the product(s) immediately.”

Changes in Marketing

Now that the label has been removed, this changes how the drug will be marketed, which is important for the brand and regulatory standards as national TV advertising makes up about 85% of Chantix’s annual total advertising spending. A 2021 study that examined the aftermath of the removal of this label, looked at the two major forms of pharmaceutical marketing permitted: 1) physician detailing, or advertising/promoting directly to physicians, and 2) direct-to-consumer advertising. This article concluded that following the positive change in status by the FDA, Chantix has seen lasting increased in advertising revenue, with the physician detailing advertising experiencing a 24-25% revenue increase from before the removal and the direct-to-consumer advertising increasing by 71%.

The FDA sets out requirements for prescription drug advertising for direct-to-consumer advertising. Notably, the FDA does not prevent drug companies for advertising any kind of prescription drugs, “even ones that can cause severe injury, addiction, or withdrawal effects.” Before its black-box warning was even removed Chantix was within the top 30 most detailed drugs, evidencing how pervasive its presence in the pharmaceutical world was and is. From a regulatory perspective, this raises concerns about how effective this labeling scheme really is, especially when it comes to health coverage.

Aftermath and Consumer Protection

A similar trend has been seen among popular SSRIs and sleep drugs that are widely prescribed yet still hold these black box warnings, such as Lexapro, Prozac, Praxil, and Ambien. This is important as is shows that these drugs are still popularly used and prescribed heavily, yet there are still strong, known risks associated with them.

For example, Lexapro is noted as carrying the “FDA’s highest safety-related warning around the risk of suicidal ideation,” and is to be closely monitored by a professional. Ambien received this warning after sixty-six cases were reported to the FDA Adverse Event Reporting System claiming that consumers of the medication engaged in dangerous activities while they were not fully awake. Of those sixty-six cases, forty-six reports “detailed non-fatal serious injuries, including accidental overdoses, falls, burns, near-drownings, exposure to extreme cold temperatures leading to loss of limb or near death, self-injuries such as gunshot wounds, and apparent suicide attempts.”

Following this 2016 removal of the black-box warnings, Chantix has continued to face pushback, proving that the change in classification from “dangerous” to “non-dangerous” was virtually meaningless. In 2021, consumers attempted to bring a class action, accusing Pfizer of failing to disclose the presence of cancer-causing agents in Chantix. In another action brought in September of this year, Baptiste v. Pfizer, Inc., a woman claimed  that Pfizer sold adulterated, misbranded and unapproved varenicline-containing drugs under the brand name Chantix.

The continued existence of these warnings on prescription drugs that are universally known and prescribed combined with the repeated issues surrounding Chantix, suggest that the FDA may need to implement stricter standards for marketing drugs and upholding consumer protections after this kind of removal, especially for such a widely used prescription drug such as Chantix.