I thought it might be good to let our readers know what a black box warning is and why they are so important. If you are like most consumers, you probably don’t read the package insert for your prescription drugs. I strongly believe the drug manufacturers are well aware of that reality. The insert is that long piece of paper that, among other things, is folded up into a tiny bundle and has very small print. The insert uses scientific words and medical terms that even some medical professionals have difficulty pronouncing. The biological pathways by which a person’s body absorbs and processes the active ingredients is described. The insert also contains a picture of the molecular orbital diagram for the drug. Additionally, the insert will list important information about warnings, side effects, and how the drug may interact with other prescriptions.
Realistically, in today’s world, most of what we know about prescriptions comes from direct-to-consumer television advertisements that are aimed at consumers. These ads – using sports figures and well known entertainers – convince viewers that the featured drug is exactly what they need to cure their ailments and make them well. In fact, if you turn on your television for more than 10 minutes, you will most assuredly see at least one commercial for some new drug to treat some obscure condition.
For example, restless leg syndrome, which allegedly deprives millions of adults of a good night’s sleep (Kramer on Seinfeld called it “the Jimmy Legs”) – could be featured. During the last five seconds of that commercial, a voiceover will list almost every warning and possible side effect imaginable. That’d done so quickly that it is virtually impossible to mentally process what it is being said. But it doesn’t stop there, because pharmaceutical companies also list warnings and possible side effects during the commercial, usually at the bottom of the screen, in white letters, against a light background, and in such tiny print that even Superman – with his great vision – would have a hard time reading it.
With that having been said, if you are not interested in reading the package insert when you get a new prescription, you should at least glance at it to see if it contains a “black box warning” at the top. For the uniformed, a black box warning is a warning by the Food and Drug Administration (FDA) found at the top of the package insert for prescription drugs. These warnings are the strictest of warnings issued by the FDA when there is reasonable evidence of any serious or life-threatening risk.
The black box warnings are based on clinical data provided to the FDA by the manufacturer through clinical trials and post-marketing surveillance. Medications found to cause serious adverse effects compared with the potential benefit from the drug are required to be reported by the manufacturer to the FDA. Once the FDA confirms a serious risk, a box warning is implemented. These warnings are placed at the top of the prescription label, in bold writing, and are enclosed by a black box, hence the name.
A black box warning is a way in which the FDA warns a person and his health care provider of serious adverse effects or life-threatening risks associated with the drug. Lawyers in our Mass Torts Section have been involved in litigation during the last 15 years that led the FDA to require black box warnings on a number of drugs due to the injuries and deaths our clients and others experienced after taking a prescription drug with inadequate warnings. To name a few, the list includes Celebrex®, Bextra®, and Prempro®.
You can easily find the package inserts for any prescription drug with an internet search. If you have any concerns regarding your prescriptions, you should check with your physician. If you need more information relating to black box warnings, contact Matt Munson, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Matt.Munson@beasleyallen.com.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.