America’s Unsafe Medical Products

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The government of the Philippines has banned the importation, sales and distribution of Dengvaxia products manufactured by Sanofi (NASDAQ: SNY) subsidiary Sanofi Pasteur, and it revoked the products’ certificates of product registration for failure 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 and Guam, as well as 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 naturally to the disease.

The FDA not only reviews and approves new drugs and other products but also issues alerts that 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 issued 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 first. Included are the type of alert and the issue date.

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.