America’s Unsafe Medical Products

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Protection Against Illnesses Caused by Vaping
> Issue date: September 6, 2019
> Type of alert: Consumer information

The FDA continues to try to determine the cause of illnesses and deaths related to using e-cigarettes (vaping). This information release specifically encourages “consumers to help protect themselves and avoid buying vaping products of any kind on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.” THC is the psychoactive ingredient in marijuana.

Parathyroid Hormone Injection Recalled
> Issue date: September 5, 2019
> Type of alert: Recall

Takeda Pharmaceutical is recalling all U.S. doses of its injectable Natpara (parathyroid hormone) drug due to potential for small rubber fragments to detach and fall into the cartridge.

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.