America’s Unsafe Medical Products

Source: AndreyPopov / iStock

The U.S. Food and Drug Administration (FDA) issued a safety warning Monday to users of test strips to monitor health conditions like blood glucose and warfarin levels.

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all MedWatch alerts for 2019 through April 8. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The 2019 alerts are listed in reverse chronological order, so the most recent are listed first. Included are the type of alert and the issue date.

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.

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.