What is an FDA black box warning? [infographic]

Misuse of prescription drugs is a serious and growing problem in Nevada, as evidenced by a recent report on HealthyAmericans.org, a Washington, D.C.-based health advocacy organization. The number of overall overdose deaths in the state jumped 80 percent since 1999, the majority of which were the result of prescription drugs. A Nevada personal injury attorney knows that the Food and Drug Administration increasingly relies on black box warnings to ensure proper use of prescriptions and to warn patients of side effects. Just how effective they are, however, is up for debate.

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What is an FDA Black Box Warning

Black box warnings intended to protect patients

According the American Academy of Family Physicians, black box warnings are large, noticeable labels applied to prescription drugs known to cause severe adverse reactions and side effects. The most serious type of warning issued by the FDA, black boxes are commonly used in the following circumstances:

  • When potentially serious side effects may counteract the benefits of a drug
  • When special attention to proper dosing is required
  • When the patient should be closely monitored while taking the drug
  • When a prescription drug is known to interact negatively with other drugs

While black box warnings are intended to highlight side effects, dosing dangers and other concerns, a Nevada personal injury attorney knows that a black box warning doesn’t automatically mean a drug should be avoided. Many drugs with these warnings can still prove highly effective when administered to appropriate patients and taken as directed. Ultimately, the decision as to whether to recommend and prescribe a medication with a black box warning is up to the physician.

Prevalence and generation of black box warnings

AAFP reports that the FDA approved 548 new drugs between 1975 and 1999, and by the year 2000, 8.2 percent of these drugs had received at least one box warning. Once drugs receive FDA approval, post-market safety evaluations are conducted to ensure the drug is safe to use. Additionally, patients, medical professionals, pharmacists and drug makers submit information regarding adverse effects or related concerns to the FDA. The FDA analyzes these reports in conjunction with the Office of Surveillance and Epidemiology and the Office of New Drugs. These organizations collaboratively determine whether the drug in question should be remain on the market, be pulled or receive a black box warning.

A Nevada personal injury attorney knows that, while prescription drugs can work miracles for many patients, their misuse can have dire consequences. The troubling numbers of prescription drug overdose deaths in Nevada bears out this concern.

More research must be done on black box warnings and whether they minimize the risks of side effects and overdoses. In the meantime, anyone who has experienced health hazards as a result of taking a prescription drug is encouraged to meet with an attorney.