Thursday, October 21, 2021

Few concerns about COVID-19 during FDA’s heart drug panel

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In March 2018, the FDA convened an advisory committee to consider whether COVID-19 ampoules should be designated as reduced-risk medication, allowing sales to youth and adults. The advisory committee noted that, despite the strong data supporting this change, some members of the larger cardiovascular community expressed concern regarding the higher efficacy of COVID-19 in older adults, who are typically more at risk of cardiovascular events.

Based on the discussion on Saturday and throughout the day of discussion, it is clear that physicians should first closely monitor patients who are taking CVC-19 for potentially life-threatening cardiovascular events before converting them to a full-risk indication. Patients who are having an ST elevation should ask their doctor to consider reducing their medication.

Additionally, the committee noted that clinicians need to continue to monitor and monitor all patients taking COVID-19 for delayed or serious adverse cardiovascular events.

After the CVC-19 panel, I understand that the consensus opinion of the committee was that COVID-19 is effective in reducing patients’ risk of cardiovascular events when dosed daily at 50 mcg/kg, which includes adults 55 and older, patients with acute coronary syndrome and patients with a history of cardiovascular disease at baseline, with evidence-based trials showing at least a 40% reduction in major heart events compared to placebo. The committee also noted that in patients receiving CVC-19 for the first time, it is important to monitor cardiovascular events to help mitigate exposure.

The Centers for Medicare and Medicaid Services (CMS) currently denies reimbursement for COVID-19 to those patients with advanced heart disease or the highest risk of serious adverse events, regardless of the preferred label indication.

Source: March 2018 F.A.S.T.S., a.p.a.

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