PMID- 23989840
OWN - NLM
STAT- MEDLINE
DCOM- 20150909
LR  - 20220311
IS  - 1943-4723 (Electronic)
IS  - 0002-8177 (Linking)
VI  - 144
IP  - 9
DP  - 2013 Sep
TI  - Adverse drug and device reactions in the oral cavity: surveillance and reporting.
PG  - 1014-21
AB  - 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.
FAU - Zavras, Athanasios I
AU  - Zavras AI
AD  - Columbia University Medical Center, 622 W. 168th St., Suite PH17-306, New York, 
      NY 10032, USA. az2256@mail.cumc.columbia.edu
FAU - Rosenberg, Gregory E
AU  - Rosenberg GE
FAU - Danielson, Jared D
AU  - Danielson JD
FAU - Cartsos, Vassiliki M
AU  - Cartsos VM
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Am Dent Assoc
JT  - Journal of the American Dental Association (1939)
JID - 7503060
RN  - 0 (Dental Implants)
RN  - 0 (Pharmaceutical Preparations, Dental)
RN  - 0 (Prescription Drugs)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Cough/epidemiology
MH  - Data Mining
MH  - Deglutition Disorders/epidemiology
MH  - Dental Implants/adverse effects
MH  - Dental Instruments/adverse effects
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Dysgeusia/epidemiology
MH  - Equipment Safety
MH  - Humans
MH  - Pharmaceutical Preparations, Dental/adverse effects
MH  - Pharyngitis/epidemiology
MH  - Population Surveillance
MH  - Prescription Drugs/adverse effects
MH  - Product Surveillance, Postmarketing
MH  - Safety
MH  - United States/epidemiology
MH  - United States Food and Drug Administration
MH  - Voluntary Programs
OTO - NOTNLM
OT  - Epidemiology
OT  - U.S. Food and Drug Administration
OT  - consumer product safety
OT  - drugs
OT  - implants
OT  - legal liability
OT  - oral medicine
OT  - postmarketing product surveillance
OT  - safety management
EDAT- 2013/08/31 06:00
MHDA- 2015/09/10 06:00
CRDT- 2013/08/31 06:00
PHST- 2013/08/31 06:00 [entrez]
PHST- 2013/08/31 06:00 [pubmed]
PHST- 2015/09/10 06:00 [medline]
AID - S0002-8177(14)60591-2 [pii]
AID - 10.14219/jada.archive.2013.0228 [doi]
PST - ppublish
SO  - J Am Dent Assoc. 2013 Sep;144(9):1014-21. doi: 10.14219/jada.archive.2013.0228.