FDA Alerts: Cardiology Roundup, Summer 2023

Recalls on digoxin tablets and devices used for the inflation and deflation of aortic balloons have been the focus of cardiology-related Food and Drug Administration (FDA) MedWatch safety alerts this summer. 

FDA Drug Recalls

Lanoxin^® (digoxin)¹ 

On August 31, 2023, the FDA announced a recall for digoxin tablets, manufactured by Marlex Pharmaceuticals, for incorrect labeling: certain lots of bottles labeled as digoxin 0.125 mg contain 0.25 mg, while other lots of bottles labeled as digoxin 0.25 mg contain 0.125 mg.

• Recalled lots:
  • Digoxin 0.125 mg tablet: lot number, E3810; NDC, 10135-0747-01; expiration, 2/2025
  • Digoxin 0.25 mg tablet: lot number, E3811; NDC, 10135-0748-01; expiration, 2/2025

Digoxin 0.25 mg tablets are white to off-white, circular, beveled, uncoated tablets scored between “N” and “202” on one side and plain on the other side. Digoxin 0.125 tablets are yellow, circular, beveled, uncoated tablets scored between “N” and “201” on one side and plain on the other side.

Digoxin is used to treat mild to moderate heart failure in adults, increase the contractility of the heart muscle in children, and control the resting ventricular rate in adults with chronic atrial fibrillation. 

Patients unaware of the labeling mistake who continue to take these pills can over- or underdose on digoxin. Patients who normally take digoxin 0.125 mg, but unknowingly take digoxin 0.25 mg can experience significant drug toxicity (eg, mental disorientation, dizziness, blurred vision, memory loss, and fainting) from the unintended overdose. Patients who take digoxin 0.25 mg, but unknowingly take digoxin 0.125 mg can experience abnormal heart rate and heart failure exacerbation due to the underdose. 

There are no active reports by Marlex Pharmaceuticals of adverse events linked to this recall. 

FDA Medical Devices Recalls

Update: Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps²

The FDA has classified 6 voluntary recalls for the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices manufactured by Getinge, Maquet, and Datascope, as class I, the most serious type of recall. 

Despite concerns revolving around device shutdowns and pump stop events related to the class 1 recalls, the FDA notes that “these devices may continue to be used to provide circulatory support when necessary.”

On August 31, 2023, the FDA provided an update on the recall. 

• Reasons for recall: 
  • Electrical failures in the power source path 
  • Failures in the printed circuit board assembly in the charging path
  • Device sitting in power cart incorrectly and unable to charge the batteries
  • Device unable to auto refill the helium to inflate the balloon
  • Sensitive high priority gas change alarms halting therapy until corrected or device replaced 
  • Internal device temperature exceeds a threshold of 80° C (176°F)

IABP devices are placed in the artery of the descending aorta to electromechanically inflate and deflate intra-aortic balloons and support the left ventricle through counter pulsation.  An interruption in therapy using an IABP can result in serious patient injury or death.

Due to ongoing device failures, the FDA recommends providers consider having additional charged IABP devices available to use in the event of device failure, and to review the recent urgent medical device correction notices from Getinge, Maquet, and Datascope. 

Impella RP Flex with SmartAssist³

The FDA issued a statement on the Abiomed voluntary recall for the Impella RP Flex with SmartAssist on August 17, 2023.

• Reason for recall:
  • Inadequate labeling of precautions for treating patients with a reduced anticoagulation clotting time. 

Patients with central venous lines and cardiac cannulas with systemic anticoagulation of less than 160 to 180 seconds are most at risk for blood clot formation or deposition when Impella RP Flex with SmartAssist catheters are used. 

The Impella RP Flex with SmartAssist System catheter is placed via the internal jugular vein and can be used up to 14 days in patients who develop acute right heart failure after left ventricular assist device implantation. The device pumps into the pulmonary artery to support the right ventricle. 

There have been 12 reported injuries related to this recall, but no reports of death. Impella RP Flex with SmartAssist can still be used with the caveat that providers maintain systemic anticoagulation between 160 to 180 seconds with central venous lines and consider the risk for blood clots on indwelling lines placed before the use of Impella RP Flex with SmartAssist System. For further information, physicians can refer to the recommendations in the “best practices pathway” on Figure 5.2 of the Instructions for Use.

Drug Safety-Related Labeling Changes 

Carospir^® (spironolactone)

CMP Pharma provided an update to spironolactone use in specific populations to include a recommendation against treatment of hypertension in pediatric patients. Prior to this update, recommendation for the use of spironolactone in pediatric patients was not established.

• Use in specific populations update:
  • Not established and not recommended for the treatment of hypertension in pediatric patients due to potential risks associated with the antiandrogenic, progestogenic, and estrogenic properties of spironolactone.

The oral suspension of spironolactone is indicated for the treatment of adults with New York Heart Association class III to IV heart failure and reduced ejection fraction, hypertension, or edema caused by cirrhosis.