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The National Heart, Lung, and Blood Institute (NHLBI), in collaboration with other Institutes and Centers (IC) of the NIH, is convening a national workshop to increase understanding of the potential for dietary supplements to interfere with hemostasis and influence antithrombotic therapies. The workshop will:
- Review the effects of dietary supplements on hemostasis and antithrombotic therapies
- Develop strategies to raise awareness among patients and practitioners about the use of dietary supplements
- Formulate a framework for developing a clinical guideline for dietary supplement use in patients on antithrombotic therapies
- Promote integration of new knowledge on the subject into media platforms including NIH internet resources and web-based home monitoring systems for antithrombotic therapies
- Identify gaps in our current knowledge
- Formulate a research agenda
At the end of the workshop, various experts will express their opinions on the topics and analyze views presented at the conference by the speakers and participants. Organizers, in collaboration with the chairperson and speakers, will draft a report on the workshop for publication in a reputable medical journal.
The need for this workshop is dictated by concerns about the frequent use and adverse effects of dietary supplements among patients who are on long-term antithrombotic therapies for preventing and treating heart attack, stroke, deep vein thrombosis, pulmonary embolism, and other conditions predisposing them to thromboembolic complications. To address this issue, the meeting will bring together a broad spectrum of experts to discuss the current knowledge, review regulatory and safety issues, share recent clinical trial findings, and identify opportunities for further research. Attendance will include stakeholders from academies and industries, representatives from IC within NIH, patient advocates, and members of Federal and non-governmental regulatory and standards-setting organizations.
Cardiovascular and cerebrovascular diseases are the leading causes of death in the United States. A large number of patients receive long-term antithrombotic therapies for preventing and managing these disorders, and this number is expected to increase. Non-prescription drugs, vitamins, minerals, botanicals, homeopathies, and other complementary and alternative therapies are being promoted, which has resulted in an increased use of these products among the general population. Because antithrombotic therapies have narrow therapeutic windows, they must be monitored so that patients are not put at risk for thromboembolic or hemorrhagic complications. Unfortunately, studies have found that patients under report the use of dietary supplements and non-prescription medications to their caregivers.
To date, there have been few systematic reviews of the prevalence of non-prescription medications and their ingredients, which may either enhance or diminish the effects of prescribed antithrombotic, anticoagulant, and antiplatelet agents. Drug interactions with herbal and other dietary supplements are much more difficult to characterize and predict because these products are not required to undergo FDA review or approval prior to their marketing. They also do not need to meet the same quality standards as do prescription drugs. Therefore, manufacturers of dietary supplements may not be responsible for demonstrating the safety and efficacy of their product.
Based on pharmacodynamic and pharmacokinetic properties of the commercially available supplements and herbal remedies, the potential for interactions is high. Although practitioners are encouraged to report such interactions to the FDA, published case reports of interactions with the most widely used dietary supplements are limited. Clinical guidance for practitioners who prescribe antithrombotic medications and patients who receive them with respect to dietary supplement use is lacking. This workshop seeks to raise awareness among practitioners about the potential harm or benefit of dietary supplements to patients receiving long-term antithrombotic therapies.