The U.S. Food and Drug Administration (FDA) on Monday issued a recall on a medical device manufactured by ICU Medical Inc. (NASDAQ: ICUI) intended to keep environmental contaminants out of a drug delivery system. The recall is the 12th recall to date in 2019.
U.S. health care professionals and their patients are not alone in their susceptibility to products that don’t always work as they should. The government of the Philippines, for example, has banned the importation, sales and distribution of Dengvaxia products manufactured by Sanofi (NASDAQ: SNY) subsidiary Sanofi Pasteur and revoked the products’ certificates of product registration for failing to submit requested documentation to the country’s Food and Drug Administration (PFDA). Dengvaxia is a vaccine against dengue in humans. The agency suspended the certificates in 2017 and the products were pulled from the market pending compliance with the PFDA’s request.
Last October, the U.S. Food and Drug Administration (FDA) agreed to consider Dengvaxia on a priority review basis, meaning that a decision must be given within six months. Although dengue is rare in the continental United States, it is endemic in Puerto Rico, the U.S. Virgin Islands, Guam and in other tropical locations that U.S. citizens may visit.
The Philippines government inoculated more than 830,000 of its citizens beginning in 2016 before Sanofi Pasteur revealed the following year that Dengvaxia may raise the risk of severe dengue among children who received the vaccine without being first exposed to the disease borne by mosquitos.
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 since the beginning of 2019. 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.
ICU Medical’s 20mm ChemoLock Vial Spike
> Issue date: February 25, 2019
> Type of alert: Recall
The company is recalling 2,050 units of its CL-80S ChemoLock Vial Spike due to the potential for plastic particles to break off the protective cap, potentially entering the drug delivery system and infused into a patient’s intravenous line resulting in “serious injury or death.” ICU Medical has received no reports of adverse effects related to this issue. The devices are commonly used in pharmacies that compound their own medicines and by healthcare facilities.
> 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.