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Fda database as a potential data source to assess the public perceptions of medication side effects

Session Digital health in clinical practice

Speaker Anusith Tunhasiriwet

Congress : ESC Congress 2018

  • Topic : e-cardiology / digital health, public health, health economics, research methodology
  • Sub-topic : e-Health
  • Session type : Rapid Fire Abstracts
  • FP Number : 1112

Authors : C Krittanawong (New York,US), A Tunhasiriwet (bangkok,TH), M Aydar (Ohio,US), HU Hassan Virk (Philadelphia,US)

C. Krittanawong1 , A. Tunhasiriwet2 , M. Aydar3 , H.U. Hassan Virk4 , 1Mount Sinai School of Medicine - New York - United States of America , 2Bangkok Heart Hospital, Center of Preventive Cardiology - bangkok - Thailand , 3Kent State University, Computer science - Ohio - United States of America , 4Albert Einstein Medical Center, Division of Cardiovascular Disease - Philadelphia - United States of America ,

European Heart Journal ( 2018 ) 39 ( Supplement ), 227

Background: Recently, the Food and Drug Administration (FDA) public datasets were provided using application programming interfaces (APIs). The openFDA provides open access to FDA datasets. Over-the-counter vitamin supplements are certainly in demand in the United States. Several case reports and studies showed that vitamin supplements were associated with common side effects, such as headache, metallic taste, loss of appetite, dryness of the mouth, diarrhea, nausea, vomiting, and constipation. However, serious cardiovascular-related side effects have never been reported.

Purpose: We hypothesized that vitamin supplements may be associated with serious cardiovascular-related side effects using a direct report from the openFDA database.

Methods: We conducted a systematic search of the openFDA using the custom source code and the FDA's new public cloud computing infrastructure (, from database inception through May 2017. Vitamin supplements included were vitamin D, C, B12, multivitamins, and fish oil. An investigator created the custom source code, and two independent investigators reviewed the data. The χ2 test was used to compare the characteristics of individuals who reported adverse effects with other drugs. All p-values were two-sided, and statistical significance was determined at the level of p<0.05.

Results: All vitamin supplements have the same side effects, including constipation, diarrhea, headache, and weight gain. Among the vitamin D-associated cases, 70 reported palpitations; 51, syncope; and 60, cerebrovascular accidents. A total of 110 and 165 cases also reported chest pain and increased blood pressure as vitamin C- and B12-associated side effects, respectively. Moreover, people who take multivitamin had the highest proportion of self-report atrial fibrillation, compared with other groups of vitamin supplements (p<0.05).

Conclusions: This study demonstrates that the use of openFDA potentially determines the uncommon association between vitamin supplements and cardiovascular-related adverse events. Further studies on openFDA data mining are needed to explore uncommon cardiovascular disease side-effects related to common medications, such as statin, acetaminophen, or cough medications.

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