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J Am Dent Assoc. 2013 Sep;144(9):1014-21.

Adverse drug and device reactions in the oral cavity: surveillance and reporting.

Author information

  • 1Columbia University Medical Center, 622 W. 168th St., Suite PH17-306, New York, NY 10032, USA. az2256@mail.cumc.columbia.edu

Abstract

BACKGROUND:

According to the U.S. Centers for Disease Control and Prevention, 48 percent of Americans (roughly 144 million people) used at least one prescribed medication in the preceding month; 11 percent used five or more. The authors describe the U.S. Food and Drug Administration's (FDA's) MedWatch program, the safety surveillance system for drugs and devices in the United States, and the dentist's role with regard to voluntary reporting of adverse effects (AEs). They also identify the most frequent AEs in the oral cavity as reported in the FDA Adverse Event Reporting System (FAERS).

METHODS:

The authors reviewed the literature regarding MedWatch, and they mined data in the FAERS public database for the 100 most commonly prescribed medications and their associated AEs.

RESULTS:

Pharyngitis was the most common AE. Cough, dysgeusia and dysphagia also were common.

CONCLUSION:

The MedWatch program and its related databases contain useful information about AEs of pharmaceuticals and devices manifested in the oral cavity. Increased participation in the reporting of suspected adverse reactions will improve the national surveillance system and ultimately will protect patients' safety.

PRACTICAL IMPLICATIONS:

As pharmaceutical consumption increases exponentially for a growing segment of the population, and as innovation in dental technology and devices flourishes, dentists have a distinct role in safeguarding patients' well-being. Promptly reporting AEs in the oral cavity improves quality of care and protects patients' well-being.

KEYWORDS:

Epidemiology; U.S. Food and Drug Administration; consumer product safety; drugs; implants; legal liability; oral medicine; postmarketing product surveillance; safety management

PMID:
23989840
[PubMed - in process]
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