America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has issued five new safety alerts, three related to product recalls, one regarding a battery depletion issue in Medtronic pacemakers and one warning of dangers related to using unapproved devices for diabetes management.

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 May 17. 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.

Use of Unapproved Devices for Diabetes Management
> Issue date: May 17, 2019
> Type of alert: Safety communication

The FDA is warning diabetes patients and health care professionals against using devices such as glucose monitors and insulin dosing systems that have not been reviewed by the FDA to ensure that such devices are both effective and safe. See the FDA website for more details.

Oral Suspension Treatment Recalled for Possible Contamination
> Issue date: May 12, 2019
> Type of alert: Recall

Novartis is voluntarily recalling three lots of Promacta 12.5 mg oral suspension due to possible contamination from peanut flour. No Promacta tablets are included in the recall. See the FDA website for additional details.

Safety Notice Related to Premature Battery Depletion in Pacemakers
> Issue date: May 7, 2019
> Type of alert: Safety communication

The FDA is alerting health care providers, caregivers and patients about issues that may cause batteries in some Medtronic implantable pacemakers and cardiac resynchronization therapy pacemakers that may cause the batteries to drain more quickly than expected without warning either patients or health care providers. The full list of affected Medtronic devices is given in the FDA’s safety communication.

Recall of Tainted Erectile Dysfunction Capsules
> Issue date: May 7, 2019
> Type of alert: Recall

Stiff Boy has voluntarily recalled all lots of its The Beast capsules. The capsules are tainted with sildenafil, an FDA-approved drug for treatment of erectile dysfunction. Because the drug is present, The Beast capsules are regarded as an unapproved drug and subject to recall.