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  1. Medical Product Safety Information

E-Cigarette Products: Safety Communication - Due to the Incidents of Severe Respiratory Disease Associated with Use of an E-Cigarette Product

[Posted 08/30/2019]

AUDIENCE: Consumer, Critical Care Medicine, Emergency Medicine, Health Professional, Pulmonology 

ISSUE: As of Aug. 27, 2019, 215 possible cases have been reported from 25 states, and additional reports of pulmonary illness are under investigation. States are completing their own investigations and verifications of cases based on Center for Disease Control and Prevention (CDC) recently released standardized case definition. While some cases in each of the states are similar and appear to be linked to e-cigarette product use, more information is needed to determine what is causing the respiratory illnesses.

In many cases, patients reported a gradual start of symptoms, including:

  • breathing difficulty
  • shortness of breath
  • and/or chest pain before hospitalization.

Some cases reported mild to moderate gastrointestinal illness including:

  • vomiting
  • diarrhea
  • other symptoms such as fevers or fatigue.

Patients have also acknowledged recent use of tetrahydrocannabinol (THC)-containing e-cigarette products while speaking to healthcare personnel, or in follow-up interviews by health department staff.

BACKGROUND: The FDA has received about 80 samples and continues to receive requests from states to send more samples for the FDA to analyze. The samples represent a variety of different types of products and substances – a number of which contained incomplete information about the product. The FDA is analyzing those samples for their contents, whether they contain nicotine, substances, such as THC or other cannabinoids, or other chemicals and ingredients. The results of that testing will be shared with the respective states to aid in their investigations and will help inform the federal response.

More information is needed to better understand whether there’s a relationship between any specific products or substances and the reported illnesses. At this time, there does not appear to be one product involved in all of the cases, although THC and cannabinoids use has been reported in many cases. At this time, the specific substances within the e-cigarette products that cause illness are not known and could involve a variety of substances. FDA continues to gather information about the names of the products used, where the products were purchased, and how the products were used. That information is critical to help determine whether patterns emerge on which we can take additional action. While the FDA and CDC continue to gather more information about these incidents and any specific products or substances involved, the Agencies also believe it’s important to provide the public with useful information to help protect themselves and their loved ones, as well as continue to notify health care professionals about the illnesses, what to watch for, and how to collect and report information on these cases. 

RECOMMENDATION: As part of that commitment, CDC  issued a Health Alert Network (HAN) Health Advisory. The advisory includes the recommendation that while this investigation is ongoing: 

  • If you are concerned about these specific health risks, consider refraining from the use of e-cigarette products. 
  • Anyone who does use e-cigarette products should not buy these products off the street (e.g., e-cigarette products with THC or other cannabinoids). 
  • Anyone should not modify e-cigarette products or add any substances to these products that are not intended by the manufacturer.

Regardless of the ongoing investigation, e-cigarette products should not be used by youth, young adults, pregnant women, and adults who do not currently use tobacco products. If you use e-cigarette products, monitor yourself for symptoms (e.g., cough, shortness of breath, chest pain) and promptly seek medical attention if you have concerns about your health.

CDC and the FDA will continue to advise and alert the public as more information becomes available. Adult smokers who are attempting to quit should use evidence-based treatments, including counseling and FDA-approved medications. If you need help quitting tobacco products, including e-cigarettes, contact your doctor. If you are concerned about harmful effects from e-cigarette products, call your local poison control center at: 1-800-222-1222. We also continue to encourage the public to submit detailed reports of any unexpected tobacco- or e-cigarette-related health or product issues to the FDA via the online Safety Reporting Portal

Healthcare professionals and consumers are encouraged to report adverse events, or any problems related to these products to the Safety Reporting Portal.

[08/30/2019 - FDA Statement - FDA]

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