America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) has announced four new voluntary recalls for three drugs and one medical device. The agency also released an update on an earlier notification to health care providers related to paclitaxel-coated balloons and stents used to treat peripheral arterial disease.

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 March 18. 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, so the most recent are listed first. Included are the type of alert and the issue date.

Mylan Recalls Levoleucovorin Injection
> Issue date: March 18, 2019
> Type of alert: Recall

Mylan is voluntarily recalling two lots of its levoleucovorin 250 mg per 25 mL injection due to the presence of copper salts in the solution. The drug is used to treat cancer, among other things, and the salts found during stability testing could cause severe consequences, including pulmonary embolism.

Cook Medical Recalls Transseptal Needles
> Issue date: March 18, 2019
> Type of alert: Recall

Cook Medical is voluntarily recalling 97 transseptal needles used to access the left side of a patient’s heart during cardiac procedures. Due to a manufacturing flaw, the needle tips are missing the back bevel that creates a sharp tip. The recall was initiated by the company on February 1.

Hospira 8.4% Sodium Bicarbonate Injection
> Issue date: March 15, 2019
> Type of alert: Recall

Hospira, a division of Pfizer, is voluntarily recalling three lots of the sodium bicarbonate solution due to glass contamination. The solution is delivered intravenously to treat metabolic acidosis.

Treating Peripheral Arterial Disease With Paclitaxel-Coated Devices
> Issue date: March 15, 2019
> Type of alert: Letter to health care providers

In a letter to health care providers on January 17, 2019, the FDA notified peripheral interventionists and vascular medicine physicians of a “possible increased mortality rate after two years” compared to patients treated with non-coated balloons or bare-metal stents. Further analysis of three trials now reveals a 50% increase in mortality risk in patients treated with paclitaxel-coated devices after five years.

Legacy Pharmaceutical Packaging LLC 50 mg Losartan Tablets
> Issue date: March 15, 2019
> Type of alert: Recall

Three lots of 50 mg Losartan tablets used to treat high blood pressure were voluntarily recalled due to possible contamination of the medication manufactured by Hetero Labs.