Black Box Warnings: What Are They and What Do They Mean?


April 13, 2011

The black box warning is the strongest warning used by the U.S. Food and Drug Administration (FDA) to provide consumer safety warnings and outline drug risks. A black box warning appears on a package insert or on the label of prescription drugs that may cause serious side effects.

The text of the warning is usually surrounded by a black border, which explains the name of the warning. The FDA requires these warnings when medical studies have indicated that a drug carries a significant risk of serious or even life-threatening adverse effects. Our defective drug attorneys represent clients who suffer serious side effects from a wide variety of drugs that carry black box warnings, including but not limited to the following:

  • Avandia
  • Baycol (now recalled)
  • Darvon & Darvocet (now recalled)
  • Gadolinium
  • Prempro
  • Serzone

While doctors may receive notices as to which drugs carry black box warnings, it is not necessarily true that a physician and patient will have a conversation about a drug's black box warning after it is issued. A black box warning usually is the strongest type of warning that the FDA will issue to a drug manufacturer before a recall of the drug takes place and the medication is removed from the market. They became prominent in 2004, and the media attention toward them has increased, as have lawsuits against pharmaceutical companies that sell these dangerous drugs.

The FDA requires that a pharmacy include a package insert for every prescription drug purchased stating the drug's uses, adverse effects, drug interactions and dosage recommendations. Sometimes a pharmacist will not provide these unless you ask for them. A patient has a right to receive all of the information in the package insert. If your pharmacist tells you that he cannot give you the insert, then it is advisable to use another pharmacy.

The information included on a package insert includes the following:

  • Indications and Usage
  • Contraindications
  • Adverse Reactions
  • Reactions
  • Dosage and Administration
  • Black Box Warning

Do not confuse what is called a Patient Information Leaflet with a package insert. These are pamphlets produced by the drug companies to market their drugs for sale. Safety information is all but eliminated in these pamphlets. It is always a good idea to specifically discuss with your doctor any potential side effects and any warnings that have been issued regarding drugs that you are prescribed.

If your doctor prescribes a drug that is new to the market or has just been introduced in the past few years, you should be aware of the following facts:

  • 548 new drugs were approved in the U.S. between 1975-1999
  • By 1999, 45 drugs (8.2%) needed one or more black box warnings and 16 (2.9%) were taken off the market altogether.
  • According to one study, the estimated probability of a drug acquiring a new black-box warning or being withdrawn from the market over a period of 25 years was 20%.
  • Half of these black box warnings occurred within 7 years of the drug's introduction; 1/2 occurred within the first 2 years.

Consumers should be leery of the direct-to-consumer advertising of drugs that is now so prolific. Television, radio and print ads that overstate the benefits of drugs while understating the risk are for selling the drugs not for educating consumers. This type of misleading advertising by drug manufacturers is an increasing basis for FDA action and basis for liability in defective drug lawsuits.

You should keep a record of all the drugs you take, the dosages, the purpose of the drug, and any adverse reactions you notice (and report them to your physician and/or pharmacist). It is also a good idea to use one pharmacy that has all of this information and always check with them before using any new drugs prescribed by a specialist. Even if you are cautious and take all of these precautions, you may still suffer adverse side effects of a drug that may cause serious injury and even death.

If you or a loved one suffer serious injury or wrongful death caused by a dangerous or defective drug, the drug manufacturer may be liable for your injuries despite FDA approval of the drug. In 2008, the U.S. Supreme Court ruled, in Wyeth v. Levine, that federal regulatory approval of a medication does not shield the manufacturer from liability under state law.

Montlick and Associates represents clients who suffer serious side effects from dangerous and defective drugs, especially where drug companies fail to provide adequate warning about the dangers posed by their drugs. If you or someone you love has been the victim of defective drugs with dangerous side effects or inadequate warnings, you should contact Montlick and Associates for a free initial case evaluation. Our Georgia defective drug attorneys are available to assist clients throughout all of Georgia and the Southeast, including but not limited to Albany, Athens, Atlanta, Augusta, Columbus, Dalton, Gainesville, Macon, Marietta, Rome, Roswell, Savannah, Smyrna, Valdosta, Warner Robins and all smaller cities and rural areas in the state. Call us today for your free consultation at 1-800-LAW-NEED (1-800-529-6333) or visit us on the web at www.montlick.com where you can use our free case evaluation form or 24 Hour Live Online Chat. No matter where you are located we are just a phone call away, and we will even come to you.

Category: Personal Injury

Please Note:
Many of our blog articles discuss the law. All information provided about the law is very general in nature and should not be relied upon as legal advice. Every situation is different, and should be analyzed by a lawyer who can provide individualized advice based on the facts involved in your unique situation, and a consideration of all of the nuances of the statutes and case law that apply at the time.