Use of anticoagulants in pediatric patients in Germany
Description
- Anticoagulants are drugs that inhibit blood clotting and are used to treat and prevent thromboembolic events. Thromboembolic events are significantly less common in pediatric patients than in adults and usually occur in hospitalized patients as complications of severe acute or chronic diseases and their treatment. Venous thromboembolisms are significantly more common than arterial thromboembolisms in pediatric patients; the incidence of thrombosis in the superficial and deep veins of the legs also increases with age. Unfractionated heparin, low-molecular-weight heparin, and vitamin-K-antagonists are available for anticoagulation. In addition, two direct oral anticoagulants (DOACs), dabigatran and rivaroxaban, were approved in 2021 for the treatment and recurrence prevention of venous thromboembolisms in children. Special pediatric formulations are available for both DOACs.
To date, no data are available on the use of anticoagulants in pediatric patients in Germany. In particular, it is not known what impact the approval of the two DOACs in 2021 had on prescribing behavior. Information on prescription rates and duration of use makes it possible to classify the public health significance of possible risks and to estimate the frequency of potential signals.
In this context, the prescription patterns of anticoagulants in pediatric patients (children aged 17 years and younger) in Germany will be comprehensively analyzed based on health claims data.
The project is funded by the Federal Institute for Drugs and Medical Devices (BfArM) as part of a call for proposals for pharmacovigilance research.
Funding period
- Begin: November 2025
End: April 2027
Sponsor
- Federal Institute for Drugs and Medical Devices