Pharmaceutics

This page contains key pharmaceutical news on drug recalls, FDA clearance, safety communications and research. In cardiology, key pharmaceutic agents include antiplatelet therapies, anticoagulants, hypertension drugs, and drugs for heart failure and arrhythmias.   

Laxmi Mehta explaining statins are no longer contraindicated for pregnant women

Is statin therapy safe for pregnant women?

Laxmi Mehta, MD, explained that the use of statins when treating pregnant women is no longer forbidden. However, she added, cardiologists should always discuss it first with their patients.

Alnylam Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for vutrisiran, a subcutaneous injection the company sells under the brand name Amvuttra, to treat adult patients with transthyretin amyloid cardiomyopathy (ATTR-CM).

FDA approves vutrisiran to treat ATTR-CM

The subcutaneous drug, sold under the brand name Amvuttra, joins an ATTR-CM market that already includes Pfizer’s tafamidis (Vyndaqel, Vyndamax) and BridgeBio’s acoramidis (Attruby).

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New drug shows early potential to treat aortic stenosis in some patients without TAVR, SAVR

The drug in question, ataciguat, could help heart patients avoid aortic valve replacement—or at least put it off until later in life.

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Direct marketing to cardiologists increases uptake of some, but not all, heart failure drugs

Researchers tracked three years of CMS data to explore how meal-based marketing may influence the habits of general and advanced heart failure cardiologists.

Video of Dave Dixon explaining the impact of first FDA approval of a generic DOAC.

FDA clears first generic versions of rivaroxaban—what it means for patient care

Dave Dixon, PharmD, explored the short- and long-term impact of these approvals, noting that they could help reduce costs down the line.

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AI could help cardiologists predict bleeding, stroke risks in AFib patients on DOACs

Researchers developed several new AI models that could guide the management of patients with non-valvular atrial fibrillation. There is still some work to do in terms of accuracy, but they already appear to outperform the traditional risk scores being used today.

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Tenecteplase compares favorably to alteplase in new comparison of FDA-approved stroke drugs

Researchers explored data from nearly 80,000 patients, comparing the newest clot-busting stroke drug from Genetech with its predecessor.

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FDA approves first new clot-dissolving drug for ischemic stroke in decades

Tenecteplase is a tissue plasminogen activator given to patients through a single five-second intravenous bolus. It is only the second drug of its kind to gain FDA approval, and the first in many years.