Healthcare Business

America's Unsafe Medical Products

Paul Ausick

Aphrodisiac Capsules Marketed by SD Import
> Issue date: April 9, 2019
> Type of alert: Recall

SD Import is voluntarily recalling all lots of its Aphrodisiac Capsules because the product has been found to be tainted with sildenafil, an FDA-approved drug for erectile dysfunction. The recalled capsules have not been approved to contain sildenafil.

Glucose/Warfarin Monitor Test Strips
> Issue date: April 8, 2019
> Type of alert: Safety warning

The FDA is warning users (and caregivers) not to use test strips for these monitoring devices that were either previously owned but unused or test strips that are not authorized for sale in the United States. The strips are often available online marketplace sellers at Amazon, eBay or Craigslist and may be unsafe to use. The FDA warning provides further details.

Atrioseptostomy Dilatation Catheters Recalled
> Issue date: March 29, 2019
> Type of alert: Recall

All catheters made by Edwards Lifesciences between December 22, 2017, and January 18, 2019, and distributed between January 8, 2018, and February 25, 2019, are being recalled because of possible difficulty in deflating the balloon, which could lead to balloon fragmentation or detachment when attempting to retrieve it. One serious injury to an infant was reported. This is a Class I recall, which means that continuing to use the devices may cause serious injury or death.

Security Vulnerabilities Affecting Medtronic Implantable Cardiac Devices
> Issue date: March 21, 2019
> Type of alert: Safety communication

The FDA has confirmed cybersecurity vulnerabilities with the use of wireless telemetry from Conexus used to transmit data from implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. If the vulnerabilities were to be exploited, an unauthorized party could potentially access and manipulate an implantable device, home monitoring system or clinic programmer. Medtronic, the maker of the devices, has issued a security bulletin related to the issue.

Risks of Venclexta Treatment for Multiple Myeloma
> Issue Date: March 21, 2019
> Type of alert: Drug safety statement

The FDA is warning researchers and patients of the risks associated with the investigational use of Venclexta, a product of Abbvie and Genentech, in treating multiple myeloma base on data from a clinical trial. The drug has not been approved for the treatment of multiple myeloma. Patients currently taking the drug for approved uses should continue to do so.

Blue Fusion Dietary Supplement Capsules
> Issue date: March 21, 2019
> Type of alert: Recall

Ata Int. is voluntarily recalling all lots of Bluefusion capsules because the product is tainted with sildenafil, tadalafil and other compounds used to treat erectile dysfunction. The ingredients are undeclared active ingredients in the product that has not been approved for safety and efficacy.