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Editorial |

FDA Encourages Reporting of Tobacco Product Adverse Experiences FREE TO VIEW

Sandra S. Retzky, DO, JD, RPh, MPH
Author and Funding Information

FINANCIAL/NONFINANCIAL DISCLOSURES: None declared.

Center for Tobacco Products, US Food and Drug Administration, Silver Spring, MD

CORRESPONDENCE TO: Sandra S. Retzky, DO, JD, RPh, MPH, Office of Science, Center for Tobacco Products, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993


Copyright 2016, . All Rights Reserved.


Chest. 2016;150(6):1169-1170. doi:10.1016/j.chest.2016.08.1452
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Published online

Reporting adverse health experiences resulting from tobacco product use is an important public health initiative. The US Food and Drug Administration (FDA) has a Safety Reporting Portal (SRP) for reporting issues involving tobacco products, in addition to human or animal drug products, foods, and dietary supplements. Although most health-care professionals are familiar with reporting drug-related adverse events, they may be unaware that unexpected health or safety concerns arising from tobacco product use can also be reported. “Tobacco products” means any product made or derived from tobacco and not approved by the FDA for therapeutic use. This includes but is not limited to cigarettes, roll-your-own tobacco, cigars, smokeless tobacco, e-cigarettes, water pipe tobacco, pipe tobacco, and delivery devices and components such as e-cigarette devices and water pipe equipment. Anyone—health-care professionals, researchers, manufacturers, or the public—can submit a report to the SRP.

Voluntary reporting enables the FDA and other government agencies to identify and investigate population-based safety signals that may otherwise go unnoticed because of low frequency. To illustrate, over the past several years, five meeting abstracts have described acute eosinophilic pneumonia (AEP). Of these, four cases were associated with tobacco water pipe use.,,, All were serious events. Three cases required intubation and mechanical ventilation for up to 7 days.,, A fourth case required extracorporeal membrane oxygenation for 7 days after mechanical ventilation failed. Although not specifically tobacco related, a fifth case of AEP in a marijuana water pipe user was also reported.

These abstracts describe classic examples of AEP in previously healthy young adults presenting with acute onset of fever and hypoxia after water pipe use., Each patient had 24% or greater eosinophils in BAL fluid. Of note, two patients were new to smoking—another common finding. Although the cause of AEP remains unknown, it is thought to be an acute hypersensitivity reaction to inhaled antigens. Smoking, including exposure to secondhand smoke, is considered the most common causative agent.,

What might explain this AEP cluster in water pipe users? First, the prevalence of water pipe smoking is increasing, especially among young adults. Over the past decade, hookah bars have significantly increased in number., Today, there are almost 1,700 water pipe establishments. The result is that roughly 40% of college campuses are within 3 miles of a hookah bar.

Second, water pipe smoking dramatically increases smoke exposure, which increases the likelihood of inhaling antigens. On a per-puff basis, water pipe smoke volume is 12 times greater than that of cigarettes, with a single 45-min water pipe session creating almost 50 times the amount of smoke. Third, water pipe smoke is much richer in ultrafine respirable particles that can penetrate deep into alveolar tissue. In part, this is due to heating water pipe tobacco at lower temperatures with lighted charcoal, unlike the burning of cigarette tobacco at higher temperatures. Flavorings, so common in water pipe tobacco, add to ultrafine particle production when combusted and also have their own antigenic potential.,, Finally, water pipe smoking often occurs in lounges with many active smokers, adding additional secondary exposures. In aggregate, these characteristics may create a “perfect storm” of events resulting in AEP for susceptible individuals.

Reporting provides a means to alert health-care professionals to unexpected serious problems arising from tobacco product use. AEP is a rare disease with dire consequences, including ARDS and death. From a symptomatic and radiographic standpoint, it can be difficult to distinguish AEP from acute lung injury or severe community-acquired pneumonia and to distinguish ARDS from another cause. Good clinical outcomes depend on a high index of suspicion—something product safety alerts can stimulate. Additionally, reporting such serious health experiences facilitates investigation and appropriate regulatory action, if needed.

To the extent possible, when reporting tobacco-related adverse experiences to the SRP, reporters should provide descriptions including (1) product brand name and manufacturer, (2) concomitantly used nontobacco products (eg, marijuana, medications), (3) delivery device type and use, and (4) location or locations of adverse experience. Water pipe tobacco is often repackaged and sold under different labels by distributors and wholesalers, complicating traceability. Therefore, the easiest and most accurate way to describe a water pipe tobacco product may be to upload package pictures to the SRP, including all sides of the label and universal product code, if available. Optimally, a water pipe report will also include a detailed description of the device and its use, including (1) charcoal type (eg, natural, quick light), (2) charcoal brand, (3) number and type of hoses (eg, leather, plastic), (4) type of bowl fluid (eg, water, ice, wine, juice, milk), (5) whether sharing occurred, and (7) smoking location (eg, home, car, lounge).

The events described in these abstracts underscore the potential seriousness of water pipe-related adverse experiences. For tobacco products in general, and water pipe products in particular, reporting is more important than ever as the tobacco landscape continues to evolve.

References

U.S. Department of Health and Human Services, Food and Drug Administration. The safety reporting portal.https://www.safetyreporting.hhs.gov. Accessed July 5, 2016.
 
Raj V. .Berman A. . Acute eosinophilic pneumonia after use of a hookah (water pipe) causing severe hypoxemia requiring ECMO. Chest. 2013;144:916A- [PubMed]journal. [CrossRef]
 
Dyal H. .Singhvi A. .Patel R. .Mendez M. .Thavarajeh K. .Jennings J. . A case of eosinophilic pneumonia following recent onset of hookah smoking. Chest. 2014;146:406A- [PubMed]journal. [CrossRef]
 
Yellappa N. .Khan I. . Hook(ah)ed up pneumocytes. Chest. 2015;148:412A- [PubMed]journal. [CrossRef]
 
Hilts J. .Skinner A. .Bellam S. . Hookah, an unexpected precipitant of acute eosinophilic pneumonia. Am J Respir Crit Care Med. 2014;189:A6487- [PubMed]journal
 
Pinto S. .Spahr J. . Acute eosinophilic pneumonia after inhalation of marijuana. Am J Respir Crit Care Med. 2015;191:A6497- [PubMed]journal
 
King T.E. . Idiopathic acute eosinophilic pneumonia. UpToDate. 2015;:- [PubMed]journal
 
Philit F. .Etienne-Mastroïanni B. .Parrot A. .Guérin C. .Robert D. .Cordier J.F. . Idiopathic acute eosinophilic pneumonia: a study of 22 patients. Am J Respir Crit Care Med. 2002;166:1235-1239 [PubMed]journal. [CrossRef] [PubMed]
 
Fernández Perez E.R. .Olson A.L. .Frankel S.K. . Eosinophilic lung diseases. Med Clin North Am. 2011;95:1163-1187 [PubMed]journal. [CrossRef] [PubMed]
 
Chung M.K. .Lee S.J. .Kim M.Y. .et al Acute eosinophilic pneumonia following secondhand cigarette smoke exposure. Tuberc Respir Dis (Seoul). 2014;76:188-191 [PubMed]journal. [CrossRef] [PubMed]
 
Cobb C. .Ward K.D. .Maziak W. .et al Water pipe tobacco smoking: an emerging health crisis in the United States. Am J Health Behav. 2010;34:275-285 [PubMed]journal. [CrossRef] [PubMed]
 
Kates F.R. . Geographic proximity of water pipe smoking establishments to colleges in the US. Am J Prev Med. 2016;50:e9-e14 [PubMed]journal. [CrossRef] [PubMed]
 
Eissenberg T. .Shihadeh A. . Water pipe tobacco and cigarette smoking. Am J Prev Med. 2010;37:518-523 [PubMed]journal
 
Daher N. .Saleh R. .Jaroudi E. .et al Comparison of carcinogenic, carbon monoxide, and ultrafine particle emissions from narghile water pipe and cigarettes smoking: sidestream smoke measurements and assessment of second-hand smoke emission factors. Atmos Environ. 2010;44:8-14 [PubMed]journal. [CrossRef]
 
Joudrey P.J. .Jasie K.A. .Pykalo L. . The operation, products and promotion of water pipe businesses in New York City, Abu Dhabi and Dubai. Eastern Mediterranean Health J. 2016;22:237-243 [PubMed]journal
 
Al-Seig N. .Moammar O. .Kartan R. . Flavored cigar smoking induces eosinophilic pneumonia. Chest. 2007;131:1234-1236 [PubMed]journal. [CrossRef] [PubMed]
 

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References

U.S. Department of Health and Human Services, Food and Drug Administration. The safety reporting portal.https://www.safetyreporting.hhs.gov. Accessed July 5, 2016.
 
Raj V. .Berman A. . Acute eosinophilic pneumonia after use of a hookah (water pipe) causing severe hypoxemia requiring ECMO. Chest. 2013;144:916A- [PubMed]journal. [CrossRef]
 
Dyal H. .Singhvi A. .Patel R. .Mendez M. .Thavarajeh K. .Jennings J. . A case of eosinophilic pneumonia following recent onset of hookah smoking. Chest. 2014;146:406A- [PubMed]journal. [CrossRef]
 
Yellappa N. .Khan I. . Hook(ah)ed up pneumocytes. Chest. 2015;148:412A- [PubMed]journal. [CrossRef]
 
Hilts J. .Skinner A. .Bellam S. . Hookah, an unexpected precipitant of acute eosinophilic pneumonia. Am J Respir Crit Care Med. 2014;189:A6487- [PubMed]journal
 
Pinto S. .Spahr J. . Acute eosinophilic pneumonia after inhalation of marijuana. Am J Respir Crit Care Med. 2015;191:A6497- [PubMed]journal
 
King T.E. . Idiopathic acute eosinophilic pneumonia. UpToDate. 2015;:- [PubMed]journal
 
Philit F. .Etienne-Mastroïanni B. .Parrot A. .Guérin C. .Robert D. .Cordier J.F. . Idiopathic acute eosinophilic pneumonia: a study of 22 patients. Am J Respir Crit Care Med. 2002;166:1235-1239 [PubMed]journal. [CrossRef] [PubMed]
 
Fernández Perez E.R. .Olson A.L. .Frankel S.K. . Eosinophilic lung diseases. Med Clin North Am. 2011;95:1163-1187 [PubMed]journal. [CrossRef] [PubMed]
 
Chung M.K. .Lee S.J. .Kim M.Y. .et al Acute eosinophilic pneumonia following secondhand cigarette smoke exposure. Tuberc Respir Dis (Seoul). 2014;76:188-191 [PubMed]journal. [CrossRef] [PubMed]
 
Cobb C. .Ward K.D. .Maziak W. .et al Water pipe tobacco smoking: an emerging health crisis in the United States. Am J Health Behav. 2010;34:275-285 [PubMed]journal. [CrossRef] [PubMed]
 
Kates F.R. . Geographic proximity of water pipe smoking establishments to colleges in the US. Am J Prev Med. 2016;50:e9-e14 [PubMed]journal. [CrossRef] [PubMed]
 
Eissenberg T. .Shihadeh A. . Water pipe tobacco and cigarette smoking. Am J Prev Med. 2010;37:518-523 [PubMed]journal
 
Daher N. .Saleh R. .Jaroudi E. .et al Comparison of carcinogenic, carbon monoxide, and ultrafine particle emissions from narghile water pipe and cigarettes smoking: sidestream smoke measurements and assessment of second-hand smoke emission factors. Atmos Environ. 2010;44:8-14 [PubMed]journal. [CrossRef]
 
Joudrey P.J. .Jasie K.A. .Pykalo L. . The operation, products and promotion of water pipe businesses in New York City, Abu Dhabi and Dubai. Eastern Mediterranean Health J. 2016;22:237-243 [PubMed]journal
 
Al-Seig N. .Moammar O. .Kartan R. . Flavored cigar smoking induces eosinophilic pneumonia. Chest. 2007;131:1234-1236 [PubMed]journal. [CrossRef] [PubMed]
 
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