The Drug Warnings You May Never See – Until It's besides Late

Authored by Sheramy Tsai via The Epoch Times (emphasis ours),

The most serious drug warnings in American medicine often go unnoticed by the very people they’re meant to protect.

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Just ask Michele Mason.

In 2023, her 27-year-old daughter, Alisa, was prescribed a seven-day course of Levaquin (levofloxacin) for pneumonia at an urgent care clinic in Arizona. Neither she nor her mother had ever heard of the drug—or the risks it carried.

“I picked up her prescription, and not a word was said,” Mason told The Epoch Times. “I had never even heard of black box warnings.”

A boxed warning—often called a black box warning because of its bold black border—is the U.S. Food and Drug Administration’s most serious safety alert. It signals to doctors and pharmacists that a drug carries serious risks.

Halfway through the treatment, Alisa’s arm began to tremble, causing her to drop coffee cups. Within days, she was overwhelmed by unexplained symptoms—nerve pain, muscle weakness, and relentless joint pain. Even washing dishes became painful. Unable to work, she moved back to Michigan to live with her mother.

“I don’t know if she’ll ever be able to work again,” Mason says. “And doctors just look at you like you’re crazy.”

Alisa suffered an adverse reaction to fluoroquinolone antibiotics—a drug class flagged with the FDA’s highest safety warning. In 2008, the agency cautioned that these antibiotics could cause permanent nerve damage, tendon ruptures, and severe effects on the muscles and nervous system. But Mason was never warned. The urgent care doctor called it a “strong antibiotic,” and the pharmacy technician dispensed it without comment.

Alisa’s experience is more common than many think. Black box warnings often arrive years after a drug has been widely prescribed. Even then, many patients remain unaware until they suffer the consequences firsthand.

What Is a Black Box Warning?

Black box warnings appear at the top of a drug’s prescribing information in both printed and online materials. However, they are often absent from prescription labels, which critics say leaves patients uninformed about serious risks.

Black box warnings vary in severity. Some flag life-threatening risks, such as organ failure or suicidal thoughts. Others highlight serious but non-fatal side effects, like permanent nerve damage or birth defects. Some warnings focus on strict prescribing rules to prevent misuse or abuse.

The FDA mandates black box warnings, and pharmaceutical companies draft them based on agency guidelines.

Black box warnings were first introduced by the FDA in 1979, starting with chloramphenicol, an antibiotic linked to a rare but fatal blood disorder.

“Black box warnings were initially rare, reserved for those that were considered most important,” Dr. Paul Axelsen, a professor at the University of Pennsylvania School of Medicine, told The Epoch Times. “The first was a necessary alert about a drug that could be fatal. But over the years, these warnings have become far more common.”

A Growing Trend

As of 2022, more than 400 medications had black box warnings.

In 2023, the FDA issued more black box warnings than any previous year, extending a decade-long increase. That year alone accounted for 40 percent of all black box warnings issued over the past decade, compared to 12 percent in 2022. Many of these warnings weren’t for newly developed drugs but for widely used medications, including antidepressants, painkillers, and sleep aids.

Despite the sharp increase in black box warnings, the FDA has not conducted a formal analysis of the trend. In response to questions from The Epoch Times, the agency stated that determining the frequency and causes of these warnings over time would require manually reviewing more than 1,000 drug applications—an effort it does not consider an efficient use of resources.

What’s behind the surge? Some experts point to improved post-marketing surveillance, the FDA’s system for tracking drug safety after approval. Others worry it means more high-risk drugs are making it to market.

Social media has transformed how drug safety concerns come to light. Patient forums and advocacy groups frequently highlight potential risks, sometimes prompting others to report side effects to the FDA.

A 2021 study in JMIR Public Health and Surveillance found that social media discussions often identify drug risks months or even years—up to 9 years—before regulators take action. While these reports aren’t always reliable, online platforms have become a major influence on drug safety and could be fueling the rise in warnings.

Lawsuits have also become a driving force. More law firms now specialize in black box warning cases, holding drug manufacturers and health care providers accountable for failing to disclose risks.

“Litigation in this area has skyrocketed,” said Axelsen. “Many doctors don’t realize that not informing a patient about a black box warning can be used in court to imply that they did not inform a patient about any warnings.”

As lawsuits increase, so does pressure on regulators. Some argue that growing litigation pushes the FDA to issue warnings more aggressively, ensuring that risks are formally documented. Axelsen points out that black box warnings can shift duty to warn from drug manufacturers to doctors.

“If a drug has a black box warning, the question becomes, ‘Why didn’t the doctor warn the patient?’” he said.

When Warnings Come Too Late

Even when issued, black box warnings often come after a drug has already reached millions of patients. A 2024 Cureus study found that approximately 80 percent of these warnings result from post-marketing studies—meaning serious risks often become evident only after widespread use. Since the FDA requires strong evidence before adding a warning, many patients are exposed to harm before the risks are formally recognized.

This delay means newly approved drugs often lack black box warnings—even if they pose serious risks. By the time enough adverse events accumulate to justify a warning, thousands—sometimes millions—of prescriptions have already been filled.

The FDA acknowledges this gap, explaining that pre-market clinical trials—while thorough—can’t always predict long-term risks. Trials typically include only a few thousand patients, so rare or delayed side effects may not appear until the drug is widely used. The agency told The Epoch Times that post-market surveillance is essential for uncovering these risks and adjusting warnings as needed.

Drug manufacturers have strong financial incentives to avoid black box warnings. These warnings restrict direct-to-consumer advertising, cutting into the billions spent on TV and online drug promotions—campaigns that drive sales and boost profits.

Yet, a black box warning can also serve as a legal shield for drug makers. Once in place, it shifts liability to doctors, allowing manufacturers to argue that they disclosed the risks if a patient experiences serious side effects.

When Providers Miss the Warnings

Black box warnings are meant to improve safety but often fail to change how providers prescribe. In some cases, they introduce new risks.

One problem is awareness. Many doctors and pharmacists monitor black box warnings and discuss them with patients—this is especially true for specialist physicians who prescribe fewer types of medications than primary care physicians. However, with the sheer volume of medications they manage, other doctors may miss them entirely.

These alerts aren’t sent directly to physicians but are buried in lengthy drug inserts or electronic health record pop-ups that can be easily overlooked. A 2015 Journal of Medical Toxicology study found that emergency and pediatric doctors correctly identified medications with black box warnings only 36 percent of the time. Even when they knew a drug carried a warning, just 13 percent could recall its details. Nearly one of three admitted they had no reliable way to stay updated.

“The information in a black box warning often does not reach the prescriber,” said Axelsen. As a result, some prescribe drugs with black box warnings without even realizing it.

Pharmacists, who receive drugs in bulk packaging from manufacturers, are often the only ones who see the printed black box warnings. But with the high volume of medications they handle, they have little reason to scrutinize each label for updates, according to Axelsen.

Patients, meanwhile, are asked if they have questions when picking up prescriptions—often via a touchscreen prompt—but most don’t know to ask about black box warnings in the first place.

Even when physicians see the warnings, how they respond can vary widely. A 2014 study of half a million patients found that after an FDA warning about a diabetes drug, prescribing rates dropped—but unevenly. Some doctors cut back sharply—others barely changed. In fact, prescribing became more inconsistent after the warning, showing that FDA alerts alone aren’t enough. How hospitals and health systems enforce them determines whether they lead to real change.

The result? Many doctors unknowingly prescribe medications in violation of black box warnings—sometimes as often as 50 percent of the time. An Archives of Internal Medicine study found that 7 in 1,000 outpatients received prescriptions that directly contradicted such warnings. While most cases resulted in no harm, the findings raise a critical question—if doctors don’t see the warnings, how effective can they really be?

Although prescription technology has advanced, newer studies on black box warnings are lacking, Axelsen noted.

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