America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) issued eight new safety alerts in the month of August, four related to product recalls, one a product warning and three product safety communications.

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 August 30. 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 with the most recent listed first. Included are the type of alert and the issue date.

Severe Respiratory Disease Associated with E-Cigarette Product
> Issue date: August 30, 2019
> Type of alert: Safety communication

The FDA reported that 215 possible cases and other reports of pulmonary illness related to e-cigarette product use had been filed with the agency. The FDA and the U.S. Centers for Disease Control (CDC) have ramped up investigations into the use of these products.

Hepatitis C Drugs May Worsen Liver Function
> Issue date: August 28, 2019
> Type of alert: Safety communication

Three drugs (Mavyret, Sepatier and Vosevi) used to treat chronic hepatitis C patients with moderate to severe liver impairment have resulted in rare cases of worsening liver function or liver failure.

Compounded Drug Products Recalled
> Issue date: August 27, 2019
> Type of alert: Recall

The FDA is requesting a recall of certain compounded drugs made by Pacifico National, doing business as AmEx Pharmacy, that “pose unnecessary risks due to significant quality and sterility concerns.”

Heart Valve System Recalled
> Issue date: August 22, 2019
> Type of alert: Recall

Edwards Lifesciences is recalling 1,585 Sapien 3 Ultra delivery systems that are part of the company’s Sapien 3 Transcatheter Heart Valve System used to replace a diseased aortic valve without open-heart surgery. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.” As of the end of July, Edwards had received reports of 17 injuries and one death related to the system.

Migraine Medication May Be Contaminated
> Issue date: August 15, 2019
> Type of alert: Recall

Pfizer is voluntarily recalling two lots of its Relpax 40 mg tablets that may not meet the company’s in-house microbiological specification for the presence of two contaminants.