Danish post-marketing pharmacosurveillance of spontaneous Oral Adverse Drug Reactions 2009-2019
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Danish post-marketing pharmacosurveillance of spontaneous Oral Adverse Drug Reactions 2009-2019. / Ellefsen, Birita Sofia; Larsen, Kristine Røn; Reibel, Jesper; Kragelund, Camilla.
In: Oral Diseases, 2024.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Danish post-marketing pharmacosurveillance of spontaneous Oral Adverse Drug Reactions 2009-2019
AU - Ellefsen, Birita Sofia
AU - Larsen, Kristine Røn
AU - Reibel, Jesper
AU - Kragelund, Camilla
N1 - This article is protected by copyright. All rights reserved.
PY - 2024
Y1 - 2024
N2 - UNLABELLED: Post-marketing pharmacosurveillance is important to reduce harm to patients from marketed drugs. Oral adverse drug reactions (OADRs) are seldom reported and only few OADRs are listed scarcely in summary of product characteristics (SmPC) of drugs.OBJECTIVE: Structured search for OADRs in the Danish Medicines Agencies database from January 2009 to July 2019.RESULTS: Forty-eight % of OADRs were categorized as "serious" where Oro-facial swelling was reported 1041 times, medication-related osteonecrosis of the jaw (MRONJ) 607 times and para- and hypoaesthesia 329 times. Four-hundred-eighty OADRs in 343 cases were related to biologic or biosimilar drugs where 73% affected the jawbone as MRONJ. Physician reported 44%, dentists 19% and citizens 10% of OADRs.CONCLUSIONS: Health care professionals had a sporadic reporting pattern that seemed to be influenced by the debate in the community and in professional circles but also by the information in the SmPC of the drugs. The results indicate some reporting stimulation of OADRs in relation to Gardasil 4, Septanest, Eltroxin and MRONJ. Eventually the knowledge of OADRs increases but there is a risk of skewed information if reporting is not systematic, reliable and consistent. All healthcare professionals must be educated in spotting and reporting all suspected adverse drug reactions.
AB - UNLABELLED: Post-marketing pharmacosurveillance is important to reduce harm to patients from marketed drugs. Oral adverse drug reactions (OADRs) are seldom reported and only few OADRs are listed scarcely in summary of product characteristics (SmPC) of drugs.OBJECTIVE: Structured search for OADRs in the Danish Medicines Agencies database from January 2009 to July 2019.RESULTS: Forty-eight % of OADRs were categorized as "serious" where Oro-facial swelling was reported 1041 times, medication-related osteonecrosis of the jaw (MRONJ) 607 times and para- and hypoaesthesia 329 times. Four-hundred-eighty OADRs in 343 cases were related to biologic or biosimilar drugs where 73% affected the jawbone as MRONJ. Physician reported 44%, dentists 19% and citizens 10% of OADRs.CONCLUSIONS: Health care professionals had a sporadic reporting pattern that seemed to be influenced by the debate in the community and in professional circles but also by the information in the SmPC of the drugs. The results indicate some reporting stimulation of OADRs in relation to Gardasil 4, Septanest, Eltroxin and MRONJ. Eventually the knowledge of OADRs increases but there is a risk of skewed information if reporting is not systematic, reliable and consistent. All healthcare professionals must be educated in spotting and reporting all suspected adverse drug reactions.
U2 - 10.1111/odi.14559
DO - 10.1111/odi.14559
M3 - Journal article
C2 - 36895115
JO - Oral Diseases
JF - Oral Diseases
SN - 1354-523X
ER -
ID: 340407346