Healthcare Business

America's Unsafe Medical Products

Paul Ausick

Takeda Uloric
> Issue date:
February 21, 2019
> Type of alert: Safety announcement

Uloric is prescribed to treat gout and was approved by the FDA in 2009 on condition of conducting a post-release study. The results of that study found “an increased risk of death” from heart-related problems or deaths from any cause among patients using Uloric (febuxostat) compared to another treatment, allopurinol (brand name Zyloprim). The FDA is now requiring Takeda to include a Boxed Warning for Uloric and restricting approved use of the drug only to those patients for whom allopurinol is not effective or who suffer severe side effects from allopurinol.

Breast Implants (All Types)
> Issue date: February 7, 2019
> Type of alert: Letter to providers

The FDA is notifying health care providers in a number of specialties of reports indicating that patients with breast implants have an increased risk of developing breast implant associated–anaplastic large cell lymphoma (BIA-ALCL) with the scar tissue next to the implant. The FDA has received 457 unique medical device reports on implants, among whom nine deaths may be attributable to BIA-ALCL.

Dr. Reddy’s Levetiracetam (Antiepileptic)
> Issue date: February 5, 2019
> Type of alert: Recall

Dr. Reddy’s Laboratories, an India-based firm, is voluntarily recalling due to mislabeling its levetiracetam single-dose infusion bags sold in the United States. The amount of sodium chloride in the affected products indicates a concentration of 0.75% on the infusion bag itself and 0.54% (the correct content) on the external foil pouch. There have been no reports of adverse effects from this recall of Dr. Reddy’s antiepileptic treatment.

Abiomed Impella Right Heart Pump System
> Issue date: February 4, 2019
> Type of alert: Letter to providers

The FDA notified cardiologists, cardiothoracic surgeons and transplant surgeons that recent post-approval testing of Abiomed’s Impella heart pump system shows results suggesting a higher mortality rate for patients than in the premarket clinical studies. In pre-approval testing, the survival rate past 30 days was 73.3%; in the post-approval testing, the survival rate is 17.4%. The difference may be attributable to tighter restrictions on patients selected for the pre-approval testing.

Smith’s Medical Sterile Saline and Water
> Issue date: February 4, 2019
> Type of alert: Recall

Smith’s Medical is recalling the solution that is used in humidification products (full list) for patients undergoing respiratory therapy, tracheal wash or wound cleaning. The products may have been exposed to infectious agents due to damage to the containers the company used to package the product. A voluntary recall was begun in September 2017. The recent alert upgrades the action to a Class I recall, the FDA’s most serious category. Using these products may cause injury or death.

Letco Medical Gluthathione-L-Reduced Powder for Compounding Sterile Drugs
> Issue date: February 1, 2019
> Type of alert: Warning

The FDA is warning compounders not to use Letco Medical’s glutathione-L-reduced powder to compound sterile injectable drugs for patients. The powder has been supplied to about 100 compounders in 30 states. The FDA has received seven reports of patients experiencing adverse effects, which the agency believes is due to high levels of endotoxin (a toxin present inside a bacterial cell that is released when the cell disintegrates). FDA testing has begun.