The U.S. Food and Drug Administration (FDA) has issued three new safety alerts, one related to devices used to assess or diagnose head injuries, one related to product labeling and the third to a recall of aphrodisiac tablets.
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 11. 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.
Addyi (Flibanserin) Labeling Change
> Issue date: April 11, 2019
> Type of alert: Safety communication
Addyi from Sprout Pharmaceuticals is known as the female Viagra. The FDA has determined that the product’s labeling must be changed to reflect continuing concerns about the consumption of alcohol near in time to taking Addyi. The boxed warning, contraindication, warnings and precautions and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening.
Medical Devices Used to Test for and Diagnose Head Injuries
> Issue date: April 10, 2019
> Type of alert: Safety communications
FDA-approved devices used to assess, diagnose or manage head injuries such as concussion, traumatic brain injury and mild traumatic brain injury do not yet include any devices that may be used without an evaluation by a health care provider. Unapproved devices include smartphone or tablet-based apps that are said to be capable of determining changes in mental/cognitive status, including changes to vision, concentration, memory, balance and speech.
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.