A Seventh-day Adventist Organization

Changing drug labels to mitigate the risk of preventable complications related to the use of certain pharmaceuticals

Poor oral health is one of the major health problems facing the nation, especially among the most vulnerable people.[1] Many suffer from oral diseases including gum disease, tooth decay, and other serious oral health problems. Many systemic diseases and conditions affect oral health and examining the oral environment can often reveal the general health of a patient. There has been heightened interest in the literature on the association between oral infection and inflammation along with other chronic systemic diseases. Some systemic diseases may affect the oral environment and result in complications and symptoms such as xerostomia, a burning sensation in the mouth, candidiasis, periodontitis, bleeding or swollen gums and ulcers.[1-3]

 

Risk of Complications

The use of many prescriptions and over the counter medications among individuals with dental infections poses an increased risk of medical complications. For example, neglecting to treat oral infections before immunosuppressive therapy may result in life threatening infections.[4]This is because drug-induced immunosuppression predisposes many patients with serious and progressive bacterial dental infections to increased risk for bacteremia and potentially the more severe condition, septicemia.

Currently, drug labels for prescription medications that can facilitate systemic complications from bacterial oral lesions do not clarify that risk. Drug labels of many medications with possible oral health side effects and repercussions indicate the need for cautionary use in the presence of active infection. For example, the medication guide for Infliximab states, “you should not start taking Infliximab if you have any kind of infection.”[5] However, these labels do not explicitly state that tooth decay and gum diseases are bacterial infections.  Given that most people often do not consider such pathological conditions as infections, dental status is seldom considered by prescribing medical professionals, pharmacists, or patients, and the reference to cautionary use “if you have any kind of infection” goes unheeded.

A recent study of California physicians found that most physicians prescribing immunosuppressive and cytotoxic pharmaceuticals infrequently inquire about a patient’s dental status, seldom request dental clearance before initiating drug therapies, and rarely advise patients about the importance of maintaining dental health while taking the medication(s).[6] Without clarification that tooth decay and gum diseases are bacterial infections, many drugs are prescribed for and taken by people whose dental condition can more easily spawn serious and potentially lethal septicemias. Consequently, patients can experience avoidable injury or incapacitation.  

 

Recommendations

I recommend that drug labels for all pharmaceuticals with significant known and potential adverse oral/dental considerations should be modified to clarify the oral/dental relationships relevant to the use of these drugs. This involves the appropriate insertion of brief clauses clarifying that infections include oral infections. For example, instead of just saying “infection,” the label should be expanded to clarify that infections include tooth decay and gum diseases. This change to the warnings on the label can be voluntarily undertaken by drug manufacturers or be mandated by Federal regulatory agencies.

The proposed modification of drug labeling for all appropriate pharmaceuticals will help safeguard individuals from the risk of systemic complications seeded by dental infections and further reduce the risk of adverse oral/dental side effects from certain drugs, including that which can result from pharmaceutically induced xerostomia.

 


Paul Gavaza, Ph.D, is an Associate Professor of Pharmaceutical and Administrative Sciences at Loma Linda University School of Pharmacy and a Faculty Scholar at the Institute for Health Policy and Leadership. Dr. Gavaza’s primary research interests include social, economic and behavioral aspects of pharmacy practice and outcomes research. In his free time, he enjoys spending time with his family, writing, and playing tennis and Ping-Pong.
For more information contact Dr. Paul Gavaza here.
 
 
 
 
 

[1]U.S. Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General. Rockville, MD: National Institute of Dental and Craniofacial Research, National Institutes of Health, US Department of Health and Human Services; 2000.

[2]Khader YS, Dauod AS, El-Qaderi SS, Alkafajei A, Batayha WQ. Periodontal status of diabetics compared with nondiabetics: a meta-analysis. Journal of diabetes and its complications. 2006;20(1):59-68.

[3]Fox PC. Xerostomia: recognition and management. Dental Assistant. 2008;77(5):18-18, 20, 44-18 passim.

[4]Meurman JH, Pyrhonen S, Teerenhovi L, Lindqvist C. Oral sources of septicaemia in patients with malignancies. Oral oncology. 1997;33(6):389-397.

[5]Remicade (infliximab) medication guide. Horsham, PA. Janssen Biotech, Inc; 2013.

[6]Gavaza P, Kim W, Mosavin R, Ta N. California Physicians’ Opinions of the Interface between Oral and Overall Health: A Preliminary Study. Journal of Family Medicine and Disease Prevention. 2015;1(020):1-5.

 

 

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Please note that the views expressed in this article do not necessarily represent those of Loma Linda University Health or the Institute for Health Policy and Leadership.

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Comments (1)

  • anon

    This is an overdue request of pharmaceutical companies and the FDA. A simple, yet overlooked improvement, this is a step closer toward recognizing that the mouth and body are intimately connected and part of a whole. Reminding oral healthcare providers, pharmacists, physicians and patients of a "big-picture view" of the body and health requires constant attention and fundamental changes to our current healthcare approach and system.

    I appreciate this one recommendation.

    Thank you.

    Sep 12, 2016

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