As discussed in Part 1 of this series, the U.S. Food and Drug Administration (FDA) is the governmental entity which oversees the safety of human medical products. The FDA provides safety alerts to both professionals and the public and requires certain drug labeling changes when safety issues with drugs are identified.

The second part of this series will look at how the FDA addresses drug safety via specific warnings. It will also briefly describe a handful of the drug safety warnings and updates that were issued in the third quarter of 2017.

In September of 2016, the FDA moved oversight of drug labeling safety to the Center for Drug Evaluation and Research’s Office of Communications. This office oversees a drug labeling safety database which it makes available to the public. Labeling changes may be searched or downloaded on the FDA’s website. There is also an informational archive for research of older drugs (USFDA, 2017).

At times, the FDA intervenes, requiring the use of a boxed warning. Also known as the black box warning, it is the most serious warning issued by the FDA. Once issued, it may be found in several places including: on the drug’s package insert, in the Physicians’ Desk Reference, on the FDA website, and on the websites of companies that market the drug. The purpose of a boxed warning is to highlight any of the following conditions to those who prescribe drugs:

• There is the potential for an adverse reaction so serious, that it is essential that this potential be considered when assessing the risks and benefits of using the drug; or
• There is the potential for a serious adverse reaction that can be prevented or reduced in frequency or severity by appropriate use of the drug; or
• The FDA has approved the drug with restrictions to ensure safe use (for example, requiring that the drug only be administered in a supervised or in-patient setting).

The boxed warning may apply to a specific drug or to an entire class of drugs (USFDA, 2017).

The responsibility for prescribing drugs falls to the doctor, dentist, or others who may have prescriptive authority. It is the prescriber’s responsibility to provide patients with information regarding the risks associated with use of the drug. It is considered a professional judgment whether to utilize a drug with a boxed warning for a given scenario.

So, how is this important to you? You may utilize facts gained from this information to strengthen your case whether for the defense or the plaintiff. You should be aware of this information as you are building your case to anticipate opposing counsel’s potential arguments.

Remember that it is not uncommon to find that a patient was prescribed drugs that may interact with other medications being taken or that have black box warnings. Questions might be raised as to whether the patient was adequately informed about the risks associated with black box warnings. Delving into these scenarios could be the key to your case.

According to Rubio (2018), in the third quarter of 2017, the FDA issued an update to a variety of black box warnings already in place. Just a few of those included but were not limited to:

• Contraindication of the use of codeine and tramadol products in children under 12 years of age and in those under 18 years following tonsillectomy and/or adenoidectomy because of the risk of respiratory depression;
• Meperidine hydrochloride or Demerol has an increased risk of medication error with administration of the oral solution because of confusion between milligrams and milliliters, which can lead to accidental overdose and death;
• Canagliflozin or Invokana use has a twofold increased risk for lower limb amputations and patients should be monitored for infection, new pain or tenderness, or development of sores or ulcers to the lower extremities; and,
• Levothyroxine sodium or Thyro-Tabs should not be used for treatment of obesity or for weight loss, and in large doses can produce life-threatening toxicity.

NOTE: The information described here is a brief overview of some of the warnings and is not intended for use as a medical reference. For detailed information see the FDA website or other sources above.

It is interesting to consider that these drug label changes represent only a small number of warnings issued by the FDA in a single quarter. This is certainly one of the important reasons to have a nurse consultant available to identify and screen for potential issues related to all drug therapy involved in your cases.

Terri Chabaud, RN, CLNC
Terri Chabaud & Associates

References

Rubio, T. (2018). Perspectives: FDA expert commentaries and interviews: Drug safety warnings and updates: July-September 2017. Retrieved from https://www.medscape.com/viewarticle/890275

U.S. Food & Drug Administration (2017). MedWatch: The FDA safety information and adverse event reporting program. Retrieved from https://www.fda.gov/Safety/MedWatch/default.htm