What is a black box warning

Many highly effective prescription drugs can cause serious and dangerous for life and health side effects. Label of drugs that can cause very serious side effects differs from the label of drugs causing less dangerous adverse reactions.

  • A key feature of labels of potentially dangerous drugs is that «black box warning» is published in them.

The term «black box warning» (less often – «boxed warning») is used in the USA. In the US mass media, you can find different definitions of the term «black box warning». The simplest answers to the question « What is a black box warning? » – can be found in the Wiki and the FDA.

Almost identical definitions of the term «black box warning» are published in the free encyclopedia – wiki and FDA guide to drugs safety terms. However, you should understand that anyone could become an author of an article on the wiki. Therefore, you should not trust all information about «black box warnings» on the wiki.

The FDA gives a very simple and clear answer to the question – «What is a black box warning? ». According to the FDA, black box warning is a warning on the label of potentially hazardous RX drugs. The «Black box warning» got its name because warning about serious side effects of drug is placed in the black square outline.

To attract consumers’ attention to serious risks of prescription drugs, black box warning is placed before the description of therapeutic, pharmacological and other properties of a drug.

Having read the label of drug that can create serious risks to life and health, the person immediately draws attention to the «black box warning» and realizes that this drug should be taken with caution.

The «Black box warning» can be found on the labels of various types of prescription drugs, such as antidepressants, antipsychotics, antibiotics, diuretics, bronchodilators. Medication list in which there is black box warning consists of hundreds of prescription pharmaceutical products, including:

  • Ciprofloxacin (Cipro)
  • Salmeterol (Serevent)
  • Quetiapine (Seroquel)
  • Bupropion (Wellbutrin)
  • Levofloxacin (Levaquin)
  • Spironolactone (Aldactazide)

It should be noted that the description of potential risks in the «black box warning» always starts with the word «Warning». Any other information placed in the black square outline can be important for the patient, but is not the «black box warning».

What is a black box warning for Ciprofloxacin?

Almost all antibacterial drugs of fluoroquinolones group (including Cipro) can cause inflammation, dystrophy and tendon rupture, as well as to enhance muscle weakness in patients with autoimmune neuromuscular disease (myasthenia). This and other information about the serious side effects of Cipro antibiotic is available in the «black box warning».

What is a black box warning for Levofloxacin?

Just as Ciprofloxacin, Levofloxacin is a fluoroquinolone antibiotic. Thus, it is not surprising that the black box warning for Levofloxacin and Ciprofloxacin is absolutely identical. It should be noted that both similarities and differences could be in the black box warning for fluoroquinolones. Therefore, after the replacement of one fluoroquinolone by another, again carefully study its label.

What is a black box warning for Quetiapine?

Quetiapine antipsychotic can cause serious psychiatric side effects in children and adults. In addition, almost all antipsychotics (including Quetiapine) create potential risks to the health and life of elderly people. Therefore, the black box warning for Quetiapine and other antipsychotic drugs is similar.

What is a black box warning for Bupropion?

Just as antipsychotics, antidepressants (including Wellbutrin) can cause serious neuropsychiatric events. In the black box warning for Wellbutrin, you can find the detailed information what psychiatric side effects this antidepressant can cause. Before prescribing Wellbutrin, the doctor should warn the patient about all cons and pros of antidepressant therapy.

What is a black box warning for Spironolactone?

Black box warning for prescription drugs may include the information not only about very dangerous side effects, but also about the requirements to their dosage and indications to their use.

For example, black box warning for Spironolactone diuretic focuses on the need for dose adjustment for each clinical case, the need for dose titration for the treatment of hypertension and edema, abuse prevention, as well as other nuances requiring special attention of physicians and their patients.

What is a black box warning for Salmeterol?

Black box warnings can be placed on the labels of absolutely any dosage forms of drugs including inhalation aerosol. Salmeterol is one of the most effective antiasthmatic agents used to produce inhalation aerosol.

The advantage of Salmeterol is that it provides a long-term bronchodilator effect, therefore can be used no more than twice a day.

The disadvantage of Salmeterol is that a potential threat to the patient’s life is created when using in the combination with other drugs for asthma treatment. It is this information is placed in the black box warning for Salmeterol anti-asthmatic bronchodilator.

If your doctor decides to prescribe you one or several prescription drugs, you can ask him a question «What is a black box warning? » and how safe drugs that you will take. Having information about the symptoms and signs of potentially dangerous side effects, you will be able timely to inform your doctor about them, and thereby to reduce the possible health risks.