FDA Releases New Black Box Warning Updates on 13 Drugs

September 3, 2019 - Last month, a list of 13 medications received new black boxed warning changes, according to the FDA’s Drug Safety-Related Labeling Changes page.  

Since the 1970s, the FDA has regularly issued these “boxed warnings” (also called “black box warnings” due to how the warnings appear in certain labeling documentation) as a means to communicate strong advisory and caution to healthcare providers and consumers about drugs with serious safety risks. Once FDA determines a boxed warning as necessary, pharmaceutical companies are required to comply with adding the specific boxed warning language to product information materials and sharing with the public.

This past month’s boxed warnings included the addition of “complex sleep behaviors” for 7 of the 13 medications, all commonly prescribed to treat insomnia. 

For one of the medications, Ambien (zolpidem), the new boxed warning language can now be read as follows:

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN. Some of these events may result in serious injuries, including death. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior.

For insomnia medications, dizziness and drowsiness are not uncommon side effects but this terminology marks a notably unprecedented inclusion of labeling language for these types of drugs; particularly when some of these medicines have been on the market for decades.

Some media outlets have reported the FDA decision to add “complex sleep behaviors” as a boxed warning was made months ago and had been prompted from reports received by the agency on less than 100 patients. Since the FDA does not mandate adverse drug event reports from healthcare providers and patients, one can speculate the actual number of patients in America who experienced “complex sleep behaviors” during the period of FDA adverse event reporting analysis was likely higher.  

Of the remaining medications with boxed warning updates in August, damage to heart muscle tissue and possible fatal infusion reactions were noted for Doxil (doxorubicin). Risk of hepatitis B reactivation in patients co-infected with HCV and HBV was added for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir).

Two of the 13 drugs noted a boxed warning removal of lactic acidosis for Janumet and Janumet XR (metformin hydrochloride; sitagliptin phosphate). No reason for the removal was provided. 

One medication made a minor wording change in the existing boxed warning, Letairis (ambrisentan). 

Most of the medications with boxed warning updates have been FDA approved for decades. Ambien, Ambien CR, Edular (zolpidem), Intermezzo (zolpidem tartrate), Sonata (zaleplon), and Zolpimist (zolpidem tartrate) were all FDA approved in the early to mid 1990s. However, at least two of the medications are considered fairly new with FDA approvals in 2013 and 2014 respectively for Sovaldi and Harvoni.

With the majority of the 13 drugs now available in generic formulations, 5 of the 13 drugs are still being exclusively sold by their initial drug manufacturers. Those drugs were Gilead-manufactured products Harvoni, Letairis and Solvadi, as well as Merck-manufactured products Janumet and Janumet XR. 

Despite the FDA’s attempt to ensure these boxed warnings are communicated clearly and effectively to the general public, consumers may never know about boxed warnings on their current medication due to numerous factors, such as slow dissemination of boxed warnings to health care providers or poor practice in providing information about boxed warnings from healthcare provider to patient through patient counseling. Some have suggested other means to ensuring the public is aware of all black boxed warnings. 

Safest Drug will continue to monitor black boxed warning updates. We also urge healthcare providers to prioritize patient counseling as a necessary action to avoid treatment decisions where patients are uncomfortable with the potentially serious medication-induced health outcomes that may cause life-threatening conditions including death.

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Safest Drug is a 501(c)(3) non-profit on a mission to implement solutions that help to prevent and alleviate medication-related illness, disability and death. We plan to do this as consumer-focused advocates that lead education, community engagement, policy and research initiatives to better protect consumers, promote the voice of consumers' medication safety experiences and broaden the understanding of what it means to be medicated in America.

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