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A “black box, alert on one Health The product looks very scary – perhaps even more so when it is suddenly being removed from the packaging.
Americans This type of public health message was reminded on November 10, when Food and Drug Administration Announced that it is removing the “black box” warning hormone replacement therapy For menopause,
But what exactly are these warnings? What is their history, and how do they affect us? MedicineUsing the?
I am a clinical pharmacologist and pharmacist who has been studying the prescribing, safety, and effectiveness of medications for over 25 years.
Black box warnings – or as the FDA officially calls them boxed warnings – are a tool to alert pharmacists and physicians that a drug may have serious risks. These health care professionals are then expected to tell consumers about those risks.
An official source of drug information
Black box warnings for specific drugs appear on product package inserts that the FDA asks drug companies to create for each prescription drug.
Product package inserts provide health care professionals with official information about the medicine. These pamphlets are attached to bulk containers of medications purchased by pharmacies so that the pharmacist has the most up-to-date official information on the product. Package inserts are also published in textbooks such as Physicians Desk Reference and on websites operated by drug manufacturers.
The requirement for product package listings came from a consumer protection law passed in 1966, called the Fair Packaging and Labeling Act, which was intended to prevent unfair or deceptive packaging in products used by consumers.
The package insert contains a set of official information about the drug, provided by the manufacturer and regulated by the FDA. The entry should include what the drug is approved for, proper dosage and administration, and details of key clinical trial results that showed it was effective and safe.
It should also disclose any health risks the medicine may pose – such as warnings on the box.
Identifying security risks
The FDA has two categories of health risks posed by drugs: precautions and warnings. Both are listed on the package insert.
Precautions alert physicians to the potential harm that may result from minor or moderate injury to patients. On the other hand, warnings alert them to the potential risk of dangerous adverse events that could result in serious injury or death. The most serious warnings for a drug are called boxed warnings. The text of those warnings is enclosed in a black box on the insert so that physicians do not miss them.
According to a 2022 study, more than 400 drugs currently carry black box warnings.
Antidepressants are an example of this. While such medications can reduce the severity of depression symptoms, researchers have found that during the first few weeks of taking them, patients have an increased risk of suicide – especially in children and young adults. The FDA first issued a black box warning about the drug’s use in children and adolescents in 2004 and expanded the warning to young adults in 2007.
Another example is clozapine, a drug used to suppress the delusions experienced by people with schizophrenia. Although the drug is very effective, the FDA first gave it a black box warning when it was reintroduced to the market in 1989 because it can inhibit the production of white blood cells, which can lead to potentially life-threatening infections.
Hormone replacement therapy for menopause received a black box warning in 2003, when a clinical trial called the Women’s Health Initiative pointed to an increased risk of breast cancer without reduced risk of heart disease in women who used it.
About the author
C. Michael White is Distinguished Professor of Pharmacy Practice at the University of Connecticut. This article is republished from Conversation Under Creative Commons license. read the original article,
In subsequent years, reanalysis of the results from the Women’s Health Initiative, as well as data from other studies, showed that the therapy is safe for women ages 50 to 60. Newer, safer formulations of estrogen and progestin have also emerged. These factors prompted the FDA to remove the warnings in November 2025, saying the therapy does not pose significant risks.
Medical and legal realities
Black box warnings may influence physicians’ choices about whether or not to prescribe a particular drug. For example, because other drugs for schizophrenia do not have the same serious risks as clozapine, physicians usually reserve that drug for people who cannot use those other drugs.
Black box warnings may also play a role in malpractice cases. In some states, package inserts and any warnings they contain can be used to establish standards of care, holding practitioners liable for harm who deviate from them. In other states, the warnings they list may be used to support findings of negligence.
For example, the black box warning when administering the drug thalidomide states that it can cause birth defects. It directs physicians to obtain a
A negative pregnancy test before use and ensure that the patient is not able to become pregnant or is taking precautions to avoid pregnancy before taking the medication. If a person taking the drug gives birth to a child with a birth defect, failure to do so could make the physician liable.
Product package inserts are living documents. As new information becomes available, the FDA may find the drug’s risk unsustainable and may request that the drug be removed from the market. Or it may decide to remove the boxed warning from the drug if new data shows the drug is less dangerous than previously thought.