The U.S. Food and Drug Administration (FDA) is responsible for approving medications and medical devices for use in the U.S. The agency determines the indications for a drug or device, what the side effects and risks are, and decides if a drug is safe enough to use and if its risks are balanced by its benefits to patients.
Sometimes the approval of a drug by the FDA is given in spite of serious potential risks, some of which are even life-threatening. The FDA has to decide which patients should risk those side effects to get the benefits of a drug, and which should not. When a drug has such serious potential complications, but the FDA still believes it has some benefits, it uses a black box warning to indicate to patients and doctors just how serious the risks are.
What is the Black Box Warning?
Sometimes the FDA refers to this as simply a boxed warning, but it is also called a black box warning because it is included on packaging information for a drug at the top and with a black box around it to help it stand out to anyone reading. It is important that patients read all the information that comes with a medication. Doctors and pharmacists do their best to be aware of the risks for patients, but it is also the patient’s responsibility to be informed, especially of the black box warnings.
These warnings are designed to bring attention to the most serious risks of a medication. The FDA has the authority to require that a pharmaceutical include a boxed warning on its packaging information. It reserves these warnings for those risks that are significant, severe, and possibly life-threatening as determined by data from research. Studies into the effects of black box warnings have been mixed. For some drugs, the warnings have had the desired effect and reduced use of the drug in populations at risk. For others, the effects were minimal.
There are many examples of drugs that have received the FDA black box warning, but there are also several classes of drugs that have gotten warnings and lot of attention for them. One of these is the group of drugs known as narcotic painkillers. These are also known as opioid drugs, the drugs that are based on compounds naturally found in the opium poppy, like morphine and codeine.
Synthetic narcotic painkillers include drugs like oxycodone, hydrocodone, fentanyl, and hydromorphone, with brand names that include Dilaudid, Vicodin, Oxycontin, and Percocet, among many others. While these medications help many people cope with serious and chronic pain, they come with a very important risk: addiction. These medications are mostly in schedule II of the Drug Enforcement Administration’s classification, which means they are highly susceptible to abuse and addictive.
The recent epidemic of prescription drug abuse and addiction, mostly involving these painkillers, spurred the FDA to require more serious warnings on their labels. Boxed warnings on opioids include information about the potential for abuse and addiction and state that anyone at risk of abusing drugs should not be prescribed them. In 2016 the FDA included a new warning in the black box for opioids that are short-acting, and that these have the highest potential for abuse, that they can lead to addiction, to overdose, and ultimately to death.
Another class of drugs that has received an important black box warning from the FDA is the group known as antidepressants. These are used to treat major depression mainly, but may also be used for other types of depression, anxiety disorders, and other conditions. Examples of antidepressants include Celexa, Cymbalta, Effexor, Lexapro, Paxil, and Prozac.
Antidepressants have been around for many years. For example, Prozac, one of the earlier members of the class was first approved in 1987. It wasn’t until 2007, however, that the FDA required these medications carry a black box warning about the use of the medications in children, teens, and young adults.
The warning came after many years of anecdotal evidence and research indicated that this age group was at risk for increased suicidal thoughts and behaviors when taking antidepressants. Now all of these drugs include the warning that they should not be used in kids and teens unless a doctor believes it is the only treatment that will work and that the young person is carefully monitored for suicidal behaviors.
Type 2 Diabetes Medications
Several medications to lower blood sugar in type 2 diabetes patients have come out in recent years as the number of people struggling with this condition has skyrocketed. As drug companies rush to get them to market, information about risks trickles out more slowly. This information from studies has led to a number of black box warnings being added.
One example is Avandia, a drug approved by the FDA in 1999 and made by GlaxoSmithKline. It took several years for the FDA to require that it carry a warning about congestive heart failure. It was found that Avandia can cause heart failure or cause the chronic condition to worsen in patients who already have it. GlaxoSmithKline has since been accused of knowing about this serious risk long before the 2007 black box warning was initiated. It has been sued and has settled with plaintiffs over the matter.
Victoza is another type 2 diabetes medication that comes with a black box warning. It warns of the potential risk of developing thyroid cancer. This is an instance in which a boxed warning indicates the risk is low, but because the outcome is so serious it warrants the specific warning. So far, Victoza has only been proven to increase the risk of thyroid tumors in rats, but the cancer is rare and serious and so a warning for human patients was deemed necessary.
Many patients have felt that a black box warning came out too late for them or their loved ones. For example, young people died from suicide after taking antidepressants before the boxed warning was put in place. The parents of these young patients believed that they were not adequately warned of the risks of the drugs and that they would not have used them if they had known. Many of these people have sued the drug makers for compensation over their losses. Some lawsuits are successful, while others lack evidence that drug companies had earlier information that they failed to report.
If you have been harmed by a drug that now has a black box warning on it, you may feel you were not properly informed of risks. If you hope to file a lawsuit, let a lawyer guide your next steps and help you decide if you have a case to make.