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6 recent FDA announcements relevant for cardiologists

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The FDA provides a public service in the medical community by regulating the use of drugs and devices. Here are 6 recent developments from the FDA that you should have on your radar.

1. Monthly injection of evolocumab gained FDA approval.

   Amgen announced that the FDA approved a new single-dose monthly injection of its PCSK9 inhibitor evolocumab.

   The product (Repatha Pushtronex system) is indicated as an adjunct therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic CVD, and for patients aged 13 years and older receiving treatment for homozygous familial hypercholesterolemia. Read More

    

2. The processed- and prepared-food industry receive guidance for voluntary sodium-reduction plan.

   A draft guidance has been issued to the food industry on voluntarily reducing sodium in processed and commercially prepared food.

   The document drew praise from the American College of Cardiology and the American Heart Association. Read More

    

3. Changes coming to Nutritional Facts label to encourage healthy choices.

   New nutritional facts labels, which feature different formatting and additional information, have been designed to help consumers make healthy food choices. Read More

    

4. New trial of a large bore vascular closure recently approved; device also received CE Mark.

   Previous research has indicated that closure of large bore femoral access sites may be associated with significant increases in time to achieve hemostasis, procedure time, complications and total cost of care. The Manta device (Essential Medical, Inc.) was designed to utilize novel closure technology and features simple deployment to provide immediate hemostasis to reduce complications and costs associated with large bore closure procedures.

   Essential Medical, Inc. announced in July that it received Investigational Device Exemption approval from the FDA to begin a U.S. clinical trial of the Manta device.

   Also announced in July, the company received CE Mark approval for the Manta device. Read More

    

5. Over-the-counter loperamide has been linked to serious cardiac events.

   A drug safety communication has recently been issued stating that serious adverse cardiac events, some leading to death, can occur after taking high doses of loperamide (Imodium A-D, McNeil Consumer Healthcare), a diarrhea drug. Read More

    

6. Hyperkalemia treatment was recently denied FDA approval due to issues with manufacturing.

AstraZeneca announced that it received a complete response letter from the FDA indicating that sodium zirconium cyclosilicate (ZS-9; AstraZeneca/ZS Pharma) will not be approved at this time due to results from a manufacturing inspection. Read More