America’s Unsafe Medical Products

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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.

DG/Health Naturals Baby Cough Syrup + Mucus
> Issue Date: March 20, 2019
> Type of alert: Recall

Kingston Pharma is recalling lot KL 180157 of this product because it may be contaminated with bacteria that can produce two forms of gastrointestinal illness with symptoms of vomiting or diarrhea. No illnesses have been reported to date.